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| ID | Type | Description | Link |
|---|---|---|---|
| P60AA003510 | 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 evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. The investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will result in a greater reduction in the amount of alcohol consumed per week. The study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis and provide an estimate of likely effect sizes in order to design a more definitive study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dutasteride | Experimental | dutasteride (1 mg oral daily dose) for 8-week treatment period |
|
| Placebo | Placebo Comparator | placebo daily for 8-week treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutasteride | Drug | dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change Number of Standard Drinks Per Week. | Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history | Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Standard Drinks Per Week - Moderation by Genetic Variation | Moderation of primary outcome measure [change in standard drinks per week from baseline to end point (average weeks 7 and 8 of treatment)] by genetic variation rs12529 in neuroactive steroid biosynthetic enzyme gene AKR1C (AKR1C3*2 C-allele associated with alcohol use disorder) | Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Covault, MD, PhD | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
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4 subjects excluded during screening due to medical or laboratory exclusion (n=3) or current drug dependence (n=1); 4 subjects lost interest in participation following screening and prior to randomization to treatment arm resulting in 37 subjects available for randomization to treatment arm
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| ID | Title | Description |
|---|---|---|
| FG000 | Dutasteride | dutasteride (1 mg oral daily dose) for 8-week treatment period Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period |
| FG001 | Placebo | placebo daily for 8-week treatment period placebo: placebo capsules in same number as active drug, daily for 8-week treatment period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dutasteride | dutasteride (1 mg oral daily dose) for 8-week treatment period Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period |
| BG001 | Placebo |
| 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 | Change Number of Standard Drinks Per Week. | Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history | Posted | Mean | Standard Error | standard drinks per week | Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment) |
|
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 | Dutasteride | dutasteride (1 mg oral daily dose) for 8-week treatment period Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
28% of participants were abstinent for the entire 8-week medication treatment period which reduced ability to detect the hypothesized treatment effects of dutasteride related to alcohol's acute effects on neuroactive steroid production.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Covault | University of Connecticut School of Medicine | 860-679-7560 | jocovault@uchc.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | placebo capsules in same number as active drug, daily for 8-week treatment period |
|
|
placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Change in Standard Drinks Per Week - Moderation by Genetic Variation | Moderation of primary outcome measure [change in standard drinks per week from baseline to end point (average weeks 7 and 8 of treatment)] by genetic variation rs12529 in neuroactive steroid biosynthetic enzyme gene AKR1C (AKR1C3*2 C-allele associated with alcohol use disorder) | Posted | Mean | Standard Error | standard drinks per week | Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment) |
|
|
|
|
| 0 |
| 20 |
| 11 |
| 20 |
| EG001 | Placebo | placebo daily for 8-week treatment period placebo: placebo capsules in same number as active drug, daily for 8-week treatment period | 0 | 19 | 9 | 19 |
| Tiredness | General disorders | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| change in sleep | General disorders | Non-systematic Assessment |
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| lightheadness/dizziness | General disorders | Non-systematic Assessment |
|
| Muscle or joint ache | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Reduced libido | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Impotence | Reproductive system and breast disorders | Non-systematic Assessment |
|
| gynecomastia | Reproductive system and breast disorders | Non-systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| Superiority or Other |