A Phase 1/2 interventional study of Mifepristone 600-mg/day or placebo for a week in Alcohol Use Disorders (AUD), sponsored by Brown University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by Brown University · Phase 1/2, Interventional, and Basic science
The goal of this study is to determine if, under stress, alcohol drinking is reduced using mifepristone
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 32 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Brown University is the lead sponsor of 282 studies on the registry; 42 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
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Exclusion Criteria:
mifepristone 600-mg/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine
Drug: Mifepristone 600-mg/day or placebo for a week
matching placebo/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine
Drug: Mifepristone 600-mg/day or placebo for a week
600-mg of mifepristone for a week, compared to placebo for a week, in a stress-induced condition triggered by a single dose of 32.4 mg of yohimbine
Number of Participants Experiencing Adverse Events in the Mifepristone Versus Placebo Group as a Measure of Safety and Tolerability
Safety and tolerability was assessed by the number of participants who experienced adverse events (AEs) while taking the medication, in the mifepristone group verses the placebo group during Visit 2 through and until Visit 5. AEs were assessed at each visit and special attention was paid to any AEs experienced after administration of the oral administration of mifepristone or placebo- Visit 2 to Visit 3 (7 days total) and Visit 4 through Visit 5 (7 days total), and when it was administered with alcohol during the laboratory paradigms at visits 3 and 4.
Time frame: 5 weeks (one week of drug administration, 3 weeks of washout, followed by one week of drug administration)
Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group
Alcohol craving will be assessed by the Alcohol Craving Questionnaire Short Form - Revised (ACQ-SF-R). The ACQ-SF-R is a 12-item self-report scale that contains items from the 47-item Alcohol Craving Questionnaire (ACQ-Now). ACQ-SF-R also produces scores for compulsivity, expectancy, purposefulness, and emotionality. To assess this outcome, at the alcohol cue reactivity procedures/visits 3 and 5 during alcohol trial 1, the 12-item total ACQ will be summed for each participant and then the total score will be averaged for a mean score. The average ACQ score in the presence of alcohol cues will be compared when participants are taking mifepristone compared to placebo. The ACQ has a total score range between 0-84. A lower score indicates less subjective alcohol craving.
Time frame: 1 day
Drinking Consumption in the Mifepristone Verses Placebo Group
Number of standard drinks desired to be consumed by participants during mifepristone administration compared to placebo administration during the open bar (free choice procedure) in the alcohol cue reactivity at visits 3 and 5.
Time frame: 1 day
| Milestone | Mifepristone, Then Placebo | Placebo, Then Mifepristone |
|---|---|---|
| Started | 12 | 20 |
| Completed | 11 | 17 |
| Not completed | 1 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Milestone | Mifepristone, Then Placebo | Placebo, Then Mifepristone |
|---|---|---|
| Started | 11 | 17 |
| Completed | 11 | 17 |
| Not completed | 0 | 0 |
Safety and tolerability was assessed by the number of participants who experienced adverse events (AEs) while taking the medication, in the mifepristone group verses the placebo group during Visit 2 through and until Visit 5. AEs were assessed at each visit and special attention was paid to any AEs experienced after administration of the oral administration of mifepristone or placebo- Visit 2 to Visit 3 (7 days total) and Visit 4 through Visit 5 (7 days total), and when it was administered with alcohol during the laboratory paradigms at visits 3 and 4.
| Participants | Mifepristone | Placebo |
|---|---|---|
| Number of Participants Experiencing Adverse Events in the Mifepristone Versus Placebo Group as a Measure of Safety and Tolerability | 0 | 3 |
Alcohol craving will be assessed by the Alcohol Craving Questionnaire Short Form - Revised (ACQ-SF-R). The ACQ-SF-R is a 12-item self-report scale that contains items from the 47-item Alcohol Craving Questionnaire (ACQ-Now). ACQ-SF-R also produces scores for compulsivity, expectancy, purposefulness, and emotionality. To assess this outcome, at the alcohol cue reactivity procedures/visits 3 and 5 during alcohol trial 1, the 12-item total ACQ will be summed for each participant and then the total score will be averaged for a mean score. The average ACQ score in the presence of alcohol cues will be compared when participants are taking mifepristone compared to placebo. The ACQ has a total score range between 0-84. A lower score indicates less subjective alcohol craving.
| score on a scale | Mifepristone | Placebo |
|---|---|---|
| Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group | 42.92 ± 17.85 | 50.13 ± 19.3 |
Number of standard drinks desired to be consumed by participants during mifepristone administration compared to placebo administration during the open bar (free choice procedure) in the alcohol cue reactivity at visits 3 and 5.
| drinks | Mifepristone | Placebo |
|---|---|---|
| Drinking Consumption in the Mifepristone Verses Placebo Group | 0.8 ± 0.3 | 0.5 ± 0.2 |
Collected over AEs were monitored for 5 weeks (one week of medication administration, followed by a three week wash out period, then followed by another week of medication administration). Medication administration is randomized between subjects within a cross over design.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mifepristone | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Placebo | 0/31 (0%) | 0/31 (0%) | 3/31 (9.7%) |
| Event | Mifepristone | Placebo |
|---|---|---|
| emesisGastrointestinal disorders | 0/27 | 2/31 |
| hypertensionCardiac disorders | 0/27 | 1/31 |
| Age, Continuous(years) | Overall Sample |
|---|---|
| Mean | 42.9 ± 11.8 |
| Sex: Female, Male(Participants) | Overall Sample |
|---|---|
| Female | 5 |
| Male | 27 |
| Race/Ethnicity, Customized(Participants) | Overall Sample |
|---|---|
| African American | 9 |
| WHITE | 22 |
| Multiracial | 1 |
| Region of Enrollment(Participants) | Overall Sample |
|---|---|
| United States | 32 |
| Alcohol craving(units on a scale) | Overall Sample |
|---|---|
| Mean | 40.9 ± 14.8 |
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