Trial Outcomes & Findings for Mifepristone Treatment of Alcohol Use Disorder (NCT NCT02179749)
NCT ID: NCT02179749
Last Updated: 2022-10-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Participants will be followed for up to 12 weeks post-assignment
Results posted on
2022-10-06
Participant Flow
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.
Seventy-one subjects were excluded prior to enrollment: sixty-seven did not meet admission criteria and four declined to participate.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
32
|
22
|
|
Overall Study
COMPLETED
|
49
|
32
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Mifepristone Treatment of Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
Experimental: Mifepristone 1200 mg Daily
n=49 Participants
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.
|
Placebo Daily, 1-week
n=32 Participants
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
|
Experimental: Mifepristone 600 mg Day
n=22 Participants
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.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
44.4 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
32 participants
n=7 Participants
|
22 participants
n=5 Participants
|
103 participants
n=4 Participants
|
|
DSM-V symptom count
|
8.63 symptoms
STANDARD_DEVIATION 1.53 • n=5 Participants
|
8.22 symptoms
STANDARD_DEVIATION 1.99 • n=7 Participants
|
8.59 symptoms
STANDARD_DEVIATION 2.30 • n=5 Participants
|
8.5 symptoms
STANDARD_DEVIATION 1.86 • n=4 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for up to 12 weeks post-assignmentPopulation: Individuals with moderate or greater severity level of alcohol use disorder.
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.
Outcome measures
| Measure |
Placebo
n=32 Participants
1 week of double-blind study medication 8 weeks of counseling
|
600 mg/d of Mifepristone
n=22 Participants
1 week of double-blind study medication 8 weeks of counseling
|
1200 mg/d of Mifepristone
n=49 Participants
1 week of double-blind study medication 8 weeks of counseling
|
|---|---|---|---|
|
Drinking Quantity Per Day
|
1.25 Standard drinks per day
Standard Error 0.21
|
1.38 Standard drinks per day
Standard Error 0.21
|
1.10 Standard drinks per day
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Participants will be followed for up to 12 weeksAlcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol.
Outcome measures
| Measure |
Placebo
n=49 Participants
1 week of double-blind study medication 8 weeks of counseling
|
600 mg/d of Mifepristone
n=32 Participants
1 week of double-blind study medication 8 weeks of counseling
|
1200 mg/d of Mifepristone
n=22 Participants
1 week of double-blind study medication 8 weeks of counseling
|
|---|---|---|---|
|
Craving
|
29.02 score on a scale
Standard Error 36.69
|
33.66 score on a scale
Standard Error 36.69
|
28.33 score on a scale
Standard Error 36.69
|
Adverse Events
Experimental: Mifepristone 1200 mg Daily
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo Daily, 1-week
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Experimental: Mifepristone 600 mg Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Mifepristone 1200 mg Daily
n=49 participants at risk
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.
|
Placebo Daily, 1-week
n=32 participants at risk
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
|
Experimental: Mifepristone 600 mg Day
n=22 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/49 • 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.
|
3.1%
1/32 • 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.
|
0.00%
0/22 • 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.
|
Other adverse events
| Measure |
Experimental: Mifepristone 1200 mg Daily
n=49 participants at risk
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.
|
Placebo Daily, 1-week
n=32 participants at risk
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
|
Experimental: Mifepristone 600 mg Day
n=22 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
24.5%
12/49 • 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.
|
12.5%
4/32 • 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.
|
9.1%
2/22 • 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.
|
|
Psychiatric disorders
Fatigue
|
10.2%
5/49 • 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.
|
12.5%
4/32 • 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.
|
0.00%
0/22 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place