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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AA027273-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this study is to examine the effects of pioglitazone on stress-induced relapse risk in a laboratory model and to examine the effects of pioglitazone on drinking, stress/anxiety, and alcohol craving in the natural environment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by end of week 1, which is within standard titration parameters as per the investigator's brochure. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Heart rate will be collected before and after CPT. The change in Heart rate will be reported as [(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)]. | Baseline, about 2 minutes after the start of the cold pressor task |
| Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Heart rate will be collected before and after CPT. The change in Heart rate will be reported as [(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)]. | Week 8, about 2 minutes after the start of the Cold Pressor Task |
| Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Systolic Blood Pressure will be collected before and after CPT. The change in Systolic Blood Pressure will be reported as [( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)]. | Baseline, about 2 minutes after the start of the Cold Pressor Task |
| Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Systolic Blood Pressure will be collected before and after CPT. The change in Systolic Blood Pressure will be reported as [( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)]. | Week 8, about 2 minutes after the start of the Cold Pressor Task |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Drinking Habit as Assessed by the Number of Drinks Per Day (Timeline Followback Method) | The Timeline Followback (TLFB) method was used to assess alcohol consumption by asking study participants to self-report their number of drinks consumed each day over the past week. The change in drinking habit is reported as [(number of drinks per day at week 8) - (number of drinks per day at baseline)].-- a negative value indicates a decrease in alcohol consumption over time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin H Yoon, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center of Houston | Houston | Texas | 77030 | United States |
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Of the 67 participants enrolled, 55 were randomized; 8 were lost to follow-up before randomization, and 4 withdrew before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Pill capsules will look same as that of active drug. |
| FG001 | Pioglitazone | Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by end of week 1, which is within standard titration parameters as per the investigator's brochure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Pill capsules will look same as that of active drug. |
| BG001 | Pioglitazone | Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by end of week 1, which is within standard titration parameters as per the investigator's brochure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Heart rate will be collected before and after CPT. The change in Heart rate will be reported as [(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)]. | Posted | Mean | Standard Deviation | beats per minutes (bpm) | Baseline, about 2 minutes after the start of the cold pressor task |
|
Up to 8 weeks
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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 | Placebo | Placebo: Pill capsules will look same as that of active drug. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders | Systematic Assessment |
Due to technical problems, the data for the outcome measure "Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)" at both baseline and Week 8 were found to be unreliable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jin H Yoon, PhD | The University of Texas Health Science Center of Houston | 713-486-2800 | jin.ho.yoon@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2023 | Aug 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2022 | Aug 8, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Pill capsules will look same as that of active drug. |
|
| Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Diastolic Blood Pressure will be collected before and after CPT. The change in Diastolic Blood Pressure will be reported as [( Diastolic Blood Pressure post cold pressor task) - (Diastolic Blood Pressure pre cold pressor task)]. | Baseline, about 2 minutes after the start of the Cold Pressor Task |
| Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Diastolic Blood Pressure will be collected before and after CPT. The change in Diastolic Blood Pressure will be reported as [( Diastolic Blood Pressure post cold pressor task) - (Diastolic Blood Pressure pre cold pressor task)]. | Week 8, about 2 minutes after the start of the Cold Pressor Task |
| Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as [(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)]. | baseline, about 32 minutes after the start of the Cold Pressor Task |
| Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as [(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)]. | week 8, about 32 minutes after the start of the Cold Pressor Task |
| Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT) | The alcohol craving scale has a total score from 0 to 50, higher score indicating greater alcohol craving. During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. The Alcohol Craving Scale will be administered before and after CPT. The change in alcohol craving will be reported as [(Alcohol craving scale score post cold pressor task) - (Alcohol craving scale score pre cold pressor task)]. -- a negative value indicates a decrease in alcohol craving. | baseline, about 2 minutes after the start of the CPT |
| Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT) | The alcohol craving scale has a total score from 0 to 50, higher score indicating greater alcohol craving. During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. The Alcohol Craving Scale will be administered before and after CPT. The change in alcohol craving will be reported as [(Alcohol craving scale score post cold pressor task) - (Alcohol craving scale score pre cold pressor task)]. -- a negative value indicates a decrease in alcohol craving. | week 8, about 2 minutes after the start of the CPT |
| baseline, week 8 |
| Change in Drinking Habit as Assessed by the Number of Heavy Drinking Days (Timeline Followback Method) | The Timeline Followback (TLFB) method was used to assess alcohol consumption by asking study participants to self-report their number of drinks consumed each day over the past week. Heavy drinking is defined as 4 drinks or more per day for females and 5 or more drinks per day for males. The change in drinking habit is reported as [(number of heavy drinking days at week 8) - (number of heavy drinking days at baseline)].--A negative value indicates a decrease in the number of heavy drinking days over time. | baseline, week 8 |
| Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | Baseline |
| Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | week 1 |
| Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | week 2 |
| Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | week 3 |
| Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | week 4 |
| Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | week 5 |
| Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | week 6 |
| Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | week 7 |
| Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | week 8 |
| Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS) | The Pennsylvania Alcohol Craving Scale(PACS) total score ranges from 0 to 30, higher scores indicating more alcohol cravings. | baseline |
| Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS) | The Pennsylvania Alcohol Craving Scale(PACS) total score ranges from 0 to 30, higher scores indicating more alcohol cravings. | Week 8 |
| Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Baseline |
| Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Week 1 |
| Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Week 2 |
| Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Week 3 |
| Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Week 4 |
| Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Week 5 |
| Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Week 6 |
| Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Week 7 |
| Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Week 8 |
| Withdrawal by Subjects due to scheduling issues |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
|
|
| Primary | Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Heart rate will be collected before and after CPT. The change in Heart rate will be reported as [(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)]. | Posted | Mean | Standard Deviation | beats per minutes (bpm) | Week 8, about 2 minutes after the start of the Cold Pressor Task |
|
|
|
| Primary | Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Systolic Blood Pressure will be collected before and after CPT. The change in Systolic Blood Pressure will be reported as [( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)]. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, about 2 minutes after the start of the Cold Pressor Task |
|
|
|
| Primary | Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Systolic Blood Pressure will be collected before and after CPT. The change in Systolic Blood Pressure will be reported as [( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)]. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Week 8, about 2 minutes after the start of the Cold Pressor Task |
|
|
|
| Primary | Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Diastolic Blood Pressure will be collected before and after CPT. The change in Diastolic Blood Pressure will be reported as [( Diastolic Blood Pressure post cold pressor task) - (Diastolic Blood Pressure pre cold pressor task)]. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, about 2 minutes after the start of the Cold Pressor Task |
|
|
|
| Primary | Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Diastolic Blood Pressure will be collected before and after CPT. The change in Diastolic Blood Pressure will be reported as [( Diastolic Blood Pressure post cold pressor task) - (Diastolic Blood Pressure pre cold pressor task)]. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Week 8, about 2 minutes after the start of the Cold Pressor Task |
|
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|
| Primary | Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as [(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)]. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | baseline, about 32 minutes after the start of the Cold Pressor Task |
|
|
|
| Primary | Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT) | During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as [(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)]. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | week 8, about 32 minutes after the start of the Cold Pressor Task |
|
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|
| Primary | Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT) | The alcohol craving scale has a total score from 0 to 50, higher score indicating greater alcohol craving. During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. The Alcohol Craving Scale will be administered before and after CPT. The change in alcohol craving will be reported as [(Alcohol craving scale score post cold pressor task) - (Alcohol craving scale score pre cold pressor task)]. -- a negative value indicates a decrease in alcohol craving. | Posted | Mean | Standard Deviation | score on a scale | baseline, about 2 minutes after the start of the CPT |
|
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|
| Secondary | Change in Drinking Habit as Assessed by the Number of Drinks Per Day (Timeline Followback Method) | The Timeline Followback (TLFB) method was used to assess alcohol consumption by asking study participants to self-report their number of drinks consumed each day over the past week. The change in drinking habit is reported as [(number of drinks per day at week 8) - (number of drinks per day at baseline)].-- a negative value indicates a decrease in alcohol consumption over time. | Posted | Mean | Standard Deviation | drinks per day | baseline, week 8 |
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| Secondary | Change in Drinking Habit as Assessed by the Number of Heavy Drinking Days (Timeline Followback Method) | The Timeline Followback (TLFB) method was used to assess alcohol consumption by asking study participants to self-report their number of drinks consumed each day over the past week. Heavy drinking is defined as 4 drinks or more per day for females and 5 or more drinks per day for males. The change in drinking habit is reported as [(number of heavy drinking days at week 8) - (number of heavy drinking days at baseline)].--A negative value indicates a decrease in the number of heavy drinking days over time. | Posted | Mean | Standard Deviation | Heavy drinking days | baseline, week 8 |
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| Secondary | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | week 1 |
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| Secondary | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | week 2 |
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| Secondary | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | week 3 |
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| Secondary | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | week 4 |
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| Secondary | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | week 5 |
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| Secondary | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | week 6 |
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| Secondary | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | week 7 |
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| Secondary | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety. | Posted | Mean | Standard Deviation | score on a scale | week 8 |
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| Secondary | Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS) | The Pennsylvania Alcohol Craving Scale(PACS) total score ranges from 0 to 30, higher scores indicating more alcohol cravings. | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| Secondary | Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS) | The Pennsylvania Alcohol Craving Scale(PACS) total score ranges from 0 to 30, higher scores indicating more alcohol cravings. | Posted | Mean | Standard Deviation | score on a scale | Week 8 |
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| Secondary | Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Week 1 |
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| Secondary | Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Week 2 |
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| Secondary | Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Week 3 |
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| Secondary | Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
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| Secondary | Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Week 5 |
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| Secondary | Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
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| Secondary | Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Week 7 |
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|
| Secondary | Stress as Assessed by the Perceived Stress Scale(PSS) | The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress. | Data were only collected from participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Week 8 |
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| Primary | Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT) | The alcohol craving scale has a total score from 0 to 50, higher score indicating greater alcohol craving. During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. The Alcohol Craving Scale will be administered before and after CPT. The change in alcohol craving will be reported as [(Alcohol craving scale score post cold pressor task) - (Alcohol craving scale score pre cold pressor task)]. -- a negative value indicates a decrease in alcohol craving. | Posted | Mean | Standard Deviation | score on a scale | week 8, about 2 minutes after the start of the CPT |
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|
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| 29 |
| 0 |
| 29 |
| 25 |
| 29 |
| EG001 | Pioglitazone | Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by end of week 1, which is within standard titration parameters as per the investigator's brochure. | 0 | 26 | 0 | 26 | 22 | 26 |
| Not Sleeping Well | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Nervousness | Nervous system disorders | Systematic Assessment |
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| Blurry Vision | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Sweating | Nervous system disorders | Systematic Assessment |
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| Confusion | Nervous system disorders | Systematic Assessment |
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| Cloudiness | Nervous system disorders | Systematic Assessment |
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| Memory Loss | Nervous system disorders | Systematic Assessment |
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| Fatigue Tiredness | Nervous system disorders | Systematic Assessment |
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| Difficulty Walking | Nervous system disorders | Systematic Assessment |
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| Weakness | Nervous system disorders | Systematic Assessment |
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| Heart Racing | Nervous system disorders | Systematic Assessment |
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| Chest pain | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Stomach Cramps | Gastrointestinal disorders | Systematic Assessment |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Increased Urination | Renal and urinary disorders | Systematic Assessment |
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| Dry Mouth | Endocrine disorders | Systematic Assessment |
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| Loss of appetite | Endocrine disorders | Systematic Assessment |
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| Fever or Chills | Immune system disorders | Systematic Assessment |
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| skin rash | Immune system disorders | Systematic Assessment |
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| Muscle Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Elevated CK Levels | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Swelling | Blood and lymphatic system disorders | Systematic Assessment |
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| Change in Sexual Function | Reproductive system and breast disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |