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| ID | Type | Description | Link |
|---|---|---|---|
| 12-AA-0143 | Other Identifier | NIH |
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The study was closed to recruitment due to feasibility problems.
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Background:
- Drinking too much alcohol can injure cells in the body. Inflammation is the body s reaction to injured cells. Studies show that inflammation can cause cravings for alcohol. Researchers want to see if pioglitazone, a drug that decreases inflammation, can reduce alcohol craving. If so, it might help develop new ways to help alcoholics with craving.
Objectives:
- To see if pioglitazone can reduce alcohol craving.
Eligibility:
- Adults between 21 and 65 years of age who are alcoholic and have been drinking within the past month.
Design:
Objective: The objective of the present study is to evaluate the role of proinflammatory signaling in alcohol craving. The peroxisome proliferator-activated receptor y (PPARy) agonist pioglitazone, which modulates glial activity, will be used as an experimental treatment. Guided imagery auditory scripts will be used as an established set of stimuli to induce craving. Low dose lipopolysaccharide (LPS) administration which activates proinflammatory signaling will be used as a novel challenge, and evaluated for its ability to provoke alcohol craving. If LPS in fact induces alcohol craving, the present design will allow evaluation of whether pioglitazone can inhibit this response.
Study population: Up to 60 subjects will be recruited for a target accrual of 50 completers. Subjects will be aged 21-65 years, with alcohol dependence as their primary complaint, and without other serious medical or psychiatric conditions. They will be admitted to the NIAAA research inpatient unit at the NIH Clinical Research Center (CRC) through one of the screening protocols (05-AA-0121 Assessment and Treatment of People with Alcohol Drinking Problems ) or 14-AA-0181 "Unit and Clinic Evaluations, Screening, Assessment, and Management") which provides basic assessments and standard withdrawal treatment if needed.
Design: Following inclusion, subjects will undergo interviews for construction of guided imagery scripts, and these scripts will subsequently be used as stress-, alcohol- or neutral condition associated stimuli. Subjects will be randomized to pioglitazone (n=25; final dose: 45mg/daily) or identically looking placebo (n=25). Following at least two weeks of treatment, subjects will undergo three sessions of guided imagery, on separate days and in a counter-balanced order, exposing them to the personalized stress-, alcohol- or neutral condition associated auditory scripts, respectively. During the final week, subjects will undergo two challenge sessions, a minimum of five days apart, with lipopolysaccharide (LPS) or placebo, in counterbalanced order.
Outcome measures: Subjective ratings of mood, anxiety and craving will be obtained twice weekly throughout the study. During the challenge sessions that utilize psychological stimuli or LPS, subjective ratings of craving for alcohol, as well as ratings of negative emotions will be obtained. Lumbar puncture will be performed and cerebrospinal fluid (CSF) obtained to determine the effect of pioglitazone on levels of proinflammatory cytokines. Neuroendocrine, psychological and physiological measures will be collected for exploratory purposes. An fMRI scan will be obtained to evaluate the effect of pioglitazone on BOLD signal in response to emotionally salient visual cues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Experimental | Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days |
|
| Placebo | Placebo Comparator | Subjects received placebo on a similar dosing schedule, for a minimum total of 13 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Pioglitazone is a thiazolidinedione antidiabetic. It works by lowering blood sugar by making the cells of the body more sensitive to the action of insulin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). |
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INCLUSION CRITERIA:
Diagnostic and Statistical Manual (DSM)-IV diagnosis of alcohol dependence on Structured Clinical Interview for DSM Diagnosis (SCID) alcohol problems as primary complaint among substance use disorders, and alcohol use within the last month.
Age 21 65
Right handed
For women:
EXCLUSION CRITERIA:
Any medical illness that in the view of the investigators would compromise participation in research, as determined by medical history, physical examination, laboratory tests (see details under Screening measures below), including, but not limited to:
Psychiatric history:
Substance use disorders:
Inability or unwillingness to participate in an fMRI scan, including
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Diazgranados, M.D. | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21334376 | Background | Capuron L, Miller AH. Immune system to brain signaling: neuropsychopharmacological implications. Pharmacol Ther. 2011 May;130(2):226-38. doi: 10.1016/j.pharmthera.2011.01.014. Epub 2011 Feb 17. | |
| 21402143 | Background | Crews FT, Zou J, Qin L. Induction of innate immune genes in brain create the neurobiology of addiction. Brain Behav Immun. 2011 Jun;25 Suppl 1(Suppl 1):S4-S12. doi: 10.1016/j.bbi.2011.03.003. Epub 2011 Mar 21. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone | Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days |
| FG001 | Placebo | Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone | Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days |
| BG001 | Placebo | Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
|
Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pioglitazone | Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal glucose | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurred vision | Eye disorders | Systematic Assessment |
This study was terminated early, so the number of subjects analyzed is small.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diazgranados, Nancy | National Institute on Alcohol Abuse and Alcoholism | +1 301 435 9386 | nancy.diazgranados@nih.gov |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| D019973 | Alcohol-Related Disorders |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Placebo is an inactive tablet design to look exactly like pioglitazone |
|
|
| Alcohol Craving in Response to the Alcohol Cue Script |
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). |
| 45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 15 minutes prior to the subject receiving an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
| Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 1 hour after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
| Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 2 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
| Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 3 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
| Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 4 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
| Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 5 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
| Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 6 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
| Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | 90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
| Day 1 of the treatment period |
| Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 3 of the treatment period |
| Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 7 of the treatment period |
| Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 10 of the treatment period |
| Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 14 of the treatment period |
| Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 17 of the treatment period |
| Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 21 of the treatment period |
| Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 24 of the treatment period |
| Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 28 of the treatment period |
| Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 31 of the treatment period |
| Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 1 of the treatment period |
| Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 3 of the treatment period |
| Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 7 of the treatment period |
| Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 10 of the treatment period |
| Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 14 of the treatment period |
| Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 17 of the treatment period |
| Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 21 of the treatment period |
| Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 24 of the treatment period |
| Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 28 of the treatment period |
| Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | Day 31 of the treatment period |
| Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | Day 1 of the treatment period |
| Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | Day 3 of the treatment period |
| Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | Day 7 of the treatment period |
| Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | Day 10 of the treatment period |
| Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | Day 14 of the treatment period |
| Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | Day 17 of the treatment period |
| Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | Day 21 of the treatment period |
| Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | Day 24 of the treatment period |
| Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | Day 28 of the treatment period |
| Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | Day 31 of the treatment period |
| 17088043 | Background | Dantzer R, Kelley KW. Twenty years of research on cytokine-induced sickness behavior. Brain Behav Immun. 2007 Feb;21(2):153-60. doi: 10.1016/j.bbi.2006.09.006. Epub 2006 Nov 7. |
| 32445052 | Derived | Schwandt ML, Diazgranados N, Umhau JC, Kwako LE, George DT, Heilig M. PPARgamma activation by pioglitazone does not suppress cravings for alcohol, and is associated with a risk of myopathy in treatment seeking alcohol dependent patients: a randomized controlled proof of principle study. Psychopharmacology (Berl). 2020 Aug;237(8):2367-2380. doi: 10.1007/s00213-020-05540-w. Epub 2020 May 22. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 |
| Placebo |
Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days |
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| Primary | Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Alcohol Cue Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions | Posted | Least Squares Mean | Standard Error | Units on a scale | 15 minutes prior to the subject receiving an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
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| Primary | Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions | Posted | Least Squares Mean | Standard Error | Units on a scale | 1 hour after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
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| Primary | Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions | Posted | Least Squares Mean | Standard Error | Units on a scale | 2 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
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| Primary | Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions | Posted | Least Squares Mean | Standard Error | Units on a scale | 3 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
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| Primary | Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions | Posted | Least Squares Mean | Standard Error | Units on a scale | 4 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
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| Primary | Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions | Posted | Least Squares Mean | Standard Error | Units on a scale | 5 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
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| Primary | Alcohol Craving in Response to the Lipopolysaccharide Challenge | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions | Posted | Least Squares Mean | Standard Error | Units on a scale | 6 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period |
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| Primary | Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Primary | Alcohol Craving in Response to the Stress Script | Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Posted | Least Squares Mean | Standard Error | Units on a scale | 90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period |
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| Secondary | Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 1 of the treatment period |
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| Secondary | Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 3 of the treatment period |
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| Secondary | Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 7 of the treatment period |
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| Secondary | Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 10 of the treatment period |
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| Secondary | Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 14 of the treatment period |
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| Secondary | Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 17 of the treatment period |
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| Secondary | Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 21 of the treatment period |
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| Secondary | Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 24 of the treatment period |
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| Secondary | Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 28 of the treatment period |
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| Secondary | Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period | Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 31 of the treatment period |
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| Secondary | Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 1 of the treatment period |
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| Secondary | Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 3 of the treatment period |
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| Secondary | Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 7 of the treatment period |
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| Secondary | Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 10 of the treatment period |
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| Secondary | Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 14 of the treatment period |
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| Secondary | Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 17 of the treatment period |
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| Secondary | Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 21 of the treatment period |
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| Secondary | Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 24 of the treatment period |
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| Secondary | Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 28 of the treatment period |
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| Secondary | Depression Symptom Ratings Measured Bi-weekly During the Treatment Period | Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). | The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 31 of the treatment period |
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| Secondary | Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 1 of the treatment period |
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| Secondary | Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 3 of the treatment period |
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| Secondary | Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 7 of the treatment period |
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| Secondary | Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 10 of the treatment period |
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| Secondary | Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 14 of the treatment period |
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| Secondary | Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 17 of the treatment period |
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| Secondary | Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 21 of the treatment period |
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| Secondary | Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 24 of the treatment period |
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| Secondary | Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 28 of the treatment period |
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| Secondary | Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period | Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). | The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period | Posted | Least Squares Mean | Standard Error | Units on a scale | Day 31 of the treatment period |
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|
| 2 |
| 8 |
| 8 |
| 8 |
| EG001 | Placebo | Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days | 0 | 8 | 7 | 8 |
| Elevated Creatine Kinase | Investigations | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Blood in stool | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Buzzed | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Loss of Appetite | General disorders | Systematic Assessment |
|
| Low RBC/HGB A1C | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Sleepiness | General disorders | Systematic Assessment |
|
| Tiredness | General disorders | Systematic Assessment |
|
| Trouble Sleeping | General disorders | Systematic Assessment |
|
| Abnormal platelet count | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Elevated Creatine Kinase | Investigations | Systematic Assessment |
|
| Muscle aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Light headed | Nervous system disorders | Systematic Assessment |
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| Sinus pain | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Dark Urine | Renal and urinary disorders | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
|
| Cold-like symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Phlebitis | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001519 | Behavior |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |