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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01AA012602-11A1 | 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 primary hypotheses under test are that alcohol dependent subjects treated with mifepristone will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Korlym (mifepristone) | Active Comparator | 600 mg daily taken orally for one week |
|
| Sugar Pill | Placebo Comparator | placebo pill daily taken orally for one week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Korlym (mifepristone) | Drug | 600 mg/day, oral pill, 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Craving to Drink | Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Drinking | Number of standard drinks per week using the Timeline Followback Interview. Total number of alcoholic drinks consumed per week with a minimum value of 0 and a maximum value of 70. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J Mason, PhD | The Scripps Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Scripps Research Institute | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26121746 | Derived | Vendruscolo LF, Estey D, Goodell V, Macshane LG, Logrip ML, Schlosburg JE, McGinn MA, Zamora-Martinez ER, Belanoff JK, Hunt HJ, Sanna PP, George O, Koob GF, Edwards S, Mason BJ. Glucocorticoid receptor antagonism decreases alcohol seeking in alcohol-dependent individuals. J Clin Invest. 2015 Aug 3;125(8):3193-7. doi: 10.1172/JCI79828. Epub 2015 Jun 29. |
| Label | URL |
|---|---|
| Laboratory Website Contact Form | View source |
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Sixty six subjects were excluded from study participation due to exclusionary criteria, 2 subjects did not return after Visit 1, 4 subjects withdrew consent (2 for time constraints following Visit 1, 1 due to social motivations, 1 due to moving out of state), and 1 subject left the lab during Visit 1 when asked to provide a urine sample.
Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, CA from 03/16/2012-03/14/2014. One Hundred twenty nine non-treatment seeking, paid volunteers signed informed consent, Fifty six subjects were enrolled, and Fifty four subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Korlym (Mifepristone) | Korlym (mifepristone): 600 mg/day, oral pill, 7 days |
| FG001 | Sugar Pill | Sugar Pill: placebo, oral pill, 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Korlym (Mifepristone) | Korlym (mifepristone): 600 mg/day, oral pill, 7 days |
| BG001 | Placebo | Sugar Pill: placebo, oral pill, 7 days |
| 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 | Craving to Drink | Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80. | 1 participant who completed the study had missing VAS scores. | Posted | Mean | Standard Error | units on a scale | 1 week |
|
Adverse event data was collected at all five study visits, an average duration of 6 weeks.
Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.
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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 | Korlym (Mifepristone) | Korlym (mifepristone): 600 mg/day, oral pill, 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold Symptoms | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara J. Mason, Ph.D. | The Scripps Research Institute | 858-784-7328 | mason@scripps.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Sugar Pill | Drug | 600 mg/day, oral pill, 7 days |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| DSM-V symptom count | Diagnostic and Statistical Manual, 5th edition (DSM-V) requires 2 of 11 symptoms for a diagnosis of Alcohol Use Disorder. | Mean | Standard Deviation | number of symptoms |
|
| Years of heavy drinking | Mean | Standard Deviation | years |
|
| DSM-IV symptom count | Diagnostic and Statistical Manual, 4th edition (DSM-IV ) criteria for current Alcohol Dependence defined as three or more symptoms of dependence. | Mean | Standard Deviation | number of symptoms |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Drinking | Number of standard drinks per week using the Timeline Followback Interview. Total number of alcoholic drinks consumed per week with a minimum value of 0 and a maximum value of 70. | Three randomized subjects who met exclusionary criteria were not included in the regression analysis for drinking: two subjects were excluded for unreliable reporting and one subject was excluded for being treatment seeking. | Posted | Mean | Standard Error | alcoholic drinks per week | 2 weeks |
|
|
|
|
| 0 |
| 28 |
| 12 |
| 28 |
| EG001 | Sugar Pill | Sugar Pill: placebo, oral pill, 7 days | 0 | 26 | 8 | 26 |
| Dizzy/Foggy | Nervous system disorders | ICD9 | Systematic Assessment |
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| Abrasions/Bruises | Skin and subcutaneous tissue disorders | ICD9 | Systematic Assessment |
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| Muscle Pain | Musculoskeletal and connective tissue disorders | ICD9 | Systematic Assessment |
|
| Fatigue | General disorders | ICD9 | Systematic Assessment |
|
| Nausea/Gastrointestinal upset | Gastrointestinal disorders | ICD9 | Systematic Assessment |
|
| Headache | General disorders | ICD9 | Systematic Assessment |
|
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D002241 | Carbohydrates |
| Mixed Models Analysis |
| <0.05 |
| 2-Sided |
| No |
| Superiority or Other |