Trial Outcomes & Findings for Mifepristone for the Prevention of Relapses of Alcohol Drinking (NCT NCT02243709)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

32 participants

Primary outcome timeframe

5 weeks (one week of drug administration, 3 weeks of washout, followed by one week of drug administration)

Results posted on

2025-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	Mifepristone, Then Placebo Participants receive mifepristone 600-mg/day for one week. Participants then go through a 3 week wash out period where no medications are dispensed. Participants then receive a matched placebo (matching Mifepristone) for one week.	Placebo, Then Mifepristone Participants receive a placebo pill for one week. Participants then go through a 3 week wash out period where no medications are dispensed. Participants then receive a matched Mifepristone (600 mg/day) dose for one week.
Phase 1 STARTED	12	20
Phase 1 COMPLETED	11	17
Phase 1 NOT COMPLETED	1	3
Phase 2: Crossover to Opposite Condition STARTED	11	17
Phase 2: Crossover to Opposite Condition COMPLETED	11	17
Phase 2: Crossover to Opposite Condition NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Mifepristone, Then Placebo Participants receive mifepristone 600-mg/day for one week. Participants then go through a 3 week wash out period where no medications are dispensed. Participants then receive a matched placebo (matching Mifepristone) for one week.	Placebo, Then Mifepristone Participants receive a placebo pill for one week. Participants then go through a 3 week wash out period where no medications are dispensed. Participants then receive a matched Mifepristone (600 mg/day) dose for one week.
Phase 1 Lost to Follow-up	0	1
Phase 1 Withdrawal by Subject	1	0
Phase 1 Protocol Violation	0	1
Phase 1 Adverse Event	0	1

Baseline Characteristics

Mifepristone for the Prevention of Relapses of Alcohol Drinking

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Sample n=32 Participants All participants receive either Mifepristone (600 mg) or matched placebo that is randomized within a cross-over, double blind clinical trial.
Age, Continuous	42.9 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race/Ethnicity, Customized African American	9 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	22 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	1 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants
Alcohol craving	40.9 units on a scale STANDARD_DEVIATION 14.8 • n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks (one week of drug administration, 3 weeks of washout, followed by one week of drug administration)

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.

Outcome measures

Outcome measures
Measure	Mifepristone n=27 Participants mifepristone 600-mg/day for a week, after a single dose of 32.4-mg of yohimbine	Placebo n=31 Participants matching placebo/day for a week, after 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	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 day

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.

Outcome measures

Outcome measures
Measure	Mifepristone n=27 Participants mifepristone 600-mg/day for a week, after a single dose of 32.4-mg of yohimbine	Placebo n=31 Participants matching placebo/day for a week, after a single dose of 32.4-mg of yohimbine
Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group	42.92 score on a scale Standard Deviation 17.85	50.13 score on a scale Standard Deviation 19.3

SECONDARY outcome

Timeframe: 1 day

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.

Outcome measures

Outcome measures
Measure	Mifepristone n=27 Participants mifepristone 600-mg/day for a week, after a single dose of 32.4-mg of yohimbine	Placebo n=31 Participants matching placebo/day for a week, after a single dose of 32.4-mg of yohimbine
Drinking Consumption in the Mifepristone Verses Placebo Group	0.8 drinks Standard Error 0.3	0.5 drinks Standard Error 0.2

Adverse Events

Mifepristone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mifepristone n=27 participants at risk mifepristone 600-mg/day for a week, after a single dose of 32.4-mg of yohimbine	Placebo n=31 participants at risk matching placebo/day for a week, after a single dose of 32.4-mg of yohimbine
Gastrointestinal disorders emesis	0.00% 0/27 • 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. Participant were screened initially with a full physical assessment	6.5% 2/31 • Number of events 2 • 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. Participant were screened initially with a full physical assessment
Cardiac disorders hypertension	0.00% 0/27 • 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. Participant were screened initially with a full physical assessment	3.2% 1/31 • Number of events 1 • 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. Participant were screened initially with a full physical assessment

Additional Information

Prof. Carolina Haass-Koffler

Brown University

Phone: 4155191385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place