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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: mifepristone 1200 mg daily | Active Comparator | 1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy |
|
| Placebo daily, 1-week | Placebo Comparator | Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone 1200 mg daily | Drug | Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drinking Quantity Per Day | Drinking quantity in standard drinks per day is measured by the Timeline Followback interview. A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer. | Participants will be followed for up to 12 weeks post-assignment |
| Measure | Description | Time Frame |
|---|---|---|
| Craving | Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol. | Participants will be followed for up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J. Mason, Ph.D | The Scripps Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Scripps Research Institute | La Jolla | California | 92037 | United States |
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Seventy-one subjects were excluded prior to enrollment: sixty-seven did not meet admission criteria and four declined to participate.
Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, CA from 10/13/2014-11/6/2019. One Hundred three subjects were enrolled, One Hundred one subjects completed 1-week of medication/placebo, Ninety subjects completed 8-weeks of counseling, and Eighty-four subjects completed a 12-week follow up visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Mifepristone 1200 mg Daily | 1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy Mifepristone 1200 mg daily: Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 8 week duration. |
| FG001 | Placebo Daily, 1-week | Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 8 week duration. Placebo: Placebo tablets, Four tablets daily/am for 1-week duration. |
| FG002 | Experimental: Mifepristone 600 mg Day | 600 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy Mifepristone 600 mg daily: Mifepristone, 300 mg tablets, Four tablets daily/am (Two 300 mg and two placebo tablets) for 1-week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 8 week duration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Mifepristone 1200 mg Daily | 1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy Mifepristone 1200 mg daily: Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 8 week duration. |
| 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 | Drinking Quantity Per Day | Drinking quantity in standard drinks per day is measured by the Timeline Followback interview. A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer. | Individuals with moderate or greater severity level of alcohol use disorder. | Posted | Mean | Standard Error | Standard drinks per day | Participants will be followed for up to 12 weeks post-assignment |
|
Study medication was administered for one week. Adverse event data were collected during this 1-week of medication or placebo treatment. These treatment emergent adverse events were followed until resolution over the 8-week behavioral therapy period.
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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 | Experimental: Mifepristone 1200 mg Daily | 1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy Mifepristone 1200 mg daily: Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 8 week duration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment | Syncope episode while riding a horse resulting in a fall. Overnight hospitalization required. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol -IND | Jul 2, 2014 | Aug 9, 2022 | Prot_SAP_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan | Feb 7, 2014 | Aug 9, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent | Apr 12, 2019 | Aug 9, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Standardized behavioral therapy | Behavioral | Standardized behavioral therapy 1 time per week for 8 week duration. |
|
|
| Placebo | Drug | Placebo tablets, Four tablets daily/am for 1-week duration. |
|
|
| BG001 |
| Placebo Daily, 1-week |
Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy . Placebo: Placebo tablets, Four tablets daily/am for 1-week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 8 week duration |
| BG002 | Experimental: Mifepristone 600 mg Day | 600 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy Mifepristone 600 mg daily: Mifepristone, 300 mg tablets, Four tablets daily/am (Two 300 mg and two placebo tablets) for 1-week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 8 week duration. |
| BG003 | 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 |
|
| DSM-V symptom count | Mean | Standard Deviation | symptoms |
|
| OG002 | 1200 mg/d of Mifepristone | 1 week of double-blind study medication 8 weeks of counseling |
|
|
|
| Secondary | Craving | Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol. | Posted | Mean | Standard Error | score on a scale | Participants will be followed for up to 12 weeks |
|
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 17 |
| 49 |
| EG001 | Placebo Daily, 1-week | Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy . Placebo: Placebo tablets, Four tablets daily/am for 1-week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 8 week duration | 0 | 32 | 1 | 32 | 8 | 32 |
| EG002 | Experimental: Mifepristone 600 mg Day | 600 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy Mifepristone 600 mg daily: Mifepristone, 300 mg tablets, Four tablets daily/am (Two 300 mg and two placebo tablets) for 1-week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 8 week duration. | 0 | 22 | 0 | 22 | 2 | 22 |
|
| Fatigue | Psychiatric disorders | MedDRA | Systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |