Trial Outcomes & Findings for Dutasteride for the Reduction of Alcohol Use in Male Drinkers (NCT NCT01262287)
NCT ID: NCT01262287
Last Updated: 2017-03-20
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
47 participants
Primary outcome timeframe
Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Results posted on
2017-03-20
Participant Flow
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
Participant milestones
| Measure |
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
|
Placebo
placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
Placebo
placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Dutasteride for the Reduction of Alcohol Use in Male Drinkers
Baseline characteristics by cohort
| Measure |
Dutasteride
n=20 Participants
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
|
Placebo
n=19 Participants
placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
50.95 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
54.95 years
STANDARD_DEVIATION 7.44 • n=7 Participants
|
52.90 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)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
Outcome measures
| Measure |
Dutasteride
n=18 Participants
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
|
Placebo
n=18 Participants
placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
|
AKR1C3*2 G-carriers + Dutasteride
AKR1C3\*2 G-carriers in dutasteride arm (1 mg/day x 8 wks)
|
AKR1C3*2 G-carriers + Placebo
AKR1C3\*2 G-carriers in placebo arm
|
|---|---|---|---|---|
|
Change Number of Standard Drinks Per Week.
|
-26.2 standard drinks per week
Standard Error 4.6
|
-25.5 standard drinks per week
Standard Error 4.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)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)
Outcome measures
| Measure |
Dutasteride
n=8 Participants
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
|
Placebo
n=5 Participants
placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
|
AKR1C3*2 G-carriers + Dutasteride
n=10 Participants
AKR1C3\*2 G-carriers in dutasteride arm (1 mg/day x 8 wks)
|
AKR1C3*2 G-carriers + Placebo
n=13 Participants
AKR1C3\*2 G-carriers in placebo arm
|
|---|---|---|---|---|
|
Change in Standard Drinks Per Week - Moderation by Genetic Variation
|
-32.4 standard drinks per week
Standard Error 5.4
|
-31.2 standard drinks per week
Standard Error 13.9
|
21.8 standard drinks per week
Standard Error 6.9
|
-22.3 standard drinks per week
Standard Error 3.3
|
Adverse Events
Dutasteride
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dutasteride
n=20 participants at risk
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
|
Placebo
n=19 participants at risk
placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
General disorders
Tiredness
|
10.0%
2/20 • Number of events 2 • 8 weeks
|
10.5%
2/19 • Number of events 4 • 8 weeks
|
|
Gastrointestinal disorders
Stomach discomfort
|
20.0%
4/20 • Number of events 4 • 8 weeks
|
5.3%
1/19 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
|
General disorders
change in sleep
|
15.0%
3/20 • Number of events 14 • 8 weeks
|
15.8%
3/19 • Number of events 6 • 8 weeks
|
|
General disorders
lightheadness/dizziness
|
5.0%
1/20 • Number of events 4 • 8 weeks
|
5.3%
1/19 • Number of events 3 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle or joint ache
|
5.0%
1/20 • Number of events 1 • 8 weeks
|
5.3%
1/19 • Number of events 6 • 8 weeks
|
|
Reproductive system and breast disorders
Reduced libido
|
10.0%
2/20 • Number of events 6 • 8 weeks
|
15.8%
3/19 • Number of events 9 • 8 weeks
|
|
Reproductive system and breast disorders
Impotence
|
0.00%
0/20 • 8 weeks
|
5.3%
1/19 • Number of events 5 • 8 weeks
|
|
Reproductive system and breast disorders
gynecomastia
|
5.0%
1/20 • Number of events 2 • 8 weeks
|
0.00%
0/19 • 8 weeks
|
Additional Information
Dr. Jonathan Covault
University of Connecticut School of Medicine
Phone: 860-679-7560
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place