Trial Outcomes & Findings for Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy (NCT NCT04098302)
NCT ID: NCT04098302
Last Updated: 2025-05-09
Results Overview
The number of heavy drinking days per week (i.e., four or more drinks in a day for women and five or more drinks in a day for men). The values listed in outcome table are the average HDD per week for the last 4 weeks (9-12) of phase 1 treatment. The generalized linear mixed model analysis considered all data from the ITT sample (75 dutasteride and 80 placebo participants)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
180 participants
Primary outcome timeframe
12 weeks (from initiation to end of treatment phase 1)
Results posted on
2025-05-09
Participant Flow
Via postings at UConn Health and radio advertisements
Of the 180 consented, 10 were screen failures and 3 withdrew after screening visit. Five participants did not attend baseline visit to receive medication and 7 did return after baseline visit leaving 155 as the phase 1 modified intention to treat sample (75 dutasteride arm and 80 placebo arm).
Participant milestones
| Measure |
Dutasteride
two 0.5 mg capsules of dutasteride daily
|
Placebo Capsule
inactive placebo matched in appearance with dutasteride capsules
|
Dutasteride - Naltrexone
Phase 1 (week 1-12) dutasteride arm participants with \<60% reduction in drinks per week assigned to naltrexone 50 mg daily for Phase 2 (weeks 13-24)
|
Placebo - Dutasteride
Phase 1 (week 1-12) placebo arm participants with \<60% reduction in drinks per week assigned to dutasteride 1mg daily for Phase 2 (weeks 13-24)
|
|---|---|---|---|---|
|
Wk 1-12 Phase 1 Dutasteride or Placebo
STARTED
|
75
|
80
|
0
|
0
|
|
Wk 1-12 Phase 1 Dutasteride or Placebo
COMPLETED
|
65
|
66
|
0
|
0
|
|
Wk 1-12 Phase 1 Dutasteride or Placebo
NOT COMPLETED
|
10
|
14
|
0
|
0
|
|
Wk 13-24 for Phase 1 Non-responders
STARTED
|
0
|
0
|
49
|
59
|
|
Wk 13-24 for Phase 1 Non-responders
COMPLETED
|
0
|
0
|
44
|
53
|
|
Wk 13-24 for Phase 1 Non-responders
NOT COMPLETED
|
0
|
0
|
5
|
6
|
Reasons for withdrawal
| Measure |
Dutasteride
two 0.5 mg capsules of dutasteride daily
|
Placebo Capsule
inactive placebo matched in appearance with dutasteride capsules
|
Dutasteride - Naltrexone
Phase 1 (week 1-12) dutasteride arm participants with \<60% reduction in drinks per week assigned to naltrexone 50 mg daily for Phase 2 (weeks 13-24)
|
Placebo - Dutasteride
Phase 1 (week 1-12) placebo arm participants with \<60% reduction in drinks per week assigned to dutasteride 1mg daily for Phase 2 (weeks 13-24)
|
|---|---|---|---|---|
|
Wk 1-12 Phase 1 Dutasteride or Placebo
Withdrawal by Subject
|
3
|
11
|
0
|
0
|
|
Wk 1-12 Phase 1 Dutasteride or Placebo
Lost to Follow-up
|
5
|
0
|
0
|
0
|
|
Wk 1-12 Phase 1 Dutasteride or Placebo
Lack of Efficacy
|
2
|
3
|
0
|
0
|
|
Wk 13-24 for Phase 1 Non-responders
Lost to Follow-up
|
0
|
0
|
3
|
3
|
|
Wk 13-24 for Phase 1 Non-responders
Adverse Event
|
0
|
0
|
1
|
1
|
|
Wk 13-24 for Phase 1 Non-responders
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Wk 13-24 for Phase 1 Non-responders
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Wk 13-24 for Phase 1 Non-responders
Protocol Violation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy
Baseline characteristics by cohort
| Measure |
Dutasteride
n=75 Participants
two 0.5 mg capsules of dutasteride daily for 12 weeks
|
Placebo Capsule
n=80 Participants
inactive placebo matched in appearance with dutasteride capsules daily for 12 weeks
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
88 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
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
147 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
151 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
|
|
Region of Enrollment
United States
|
75 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Number of heavy drinking days per week
|
5.4 Heavy drinking days per week
STANDARD_DEVIATION 1.8 • n=5 Participants
|
5.6 Heavy drinking days per week
STANDARD_DEVIATION 1.7 • n=7 Participants
|
5.5 Heavy drinking days per week
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Drinks per week
|
43.2 drinks per week
STANDARD_DEVIATION 21.9 • n=5 Participants
|
43.5 drinks per week
STANDARD_DEVIATION 18.5 • n=7 Participants
|
43.4 drinks per week
STANDARD_DEVIATION 20.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (from initiation to end of treatment phase 1)Population: Participants who attended and provided outcome data for at least one study visit following baseline session.
The number of heavy drinking days per week (i.e., four or more drinks in a day for women and five or more drinks in a day for men). The values listed in outcome table are the average HDD per week for the last 4 weeks (9-12) of phase 1 treatment. The generalized linear mixed model analysis considered all data from the ITT sample (75 dutasteride and 80 placebo participants)
Outcome measures
| Measure |
Dutasteride
n=75 Participants
two 0.5 mg capsules of dutasteride daily
|
Placebo Capsule
n=80 Participants
inactive placebo matched in appearance with dutasteride capsules
|
|---|---|---|
|
Change in Heavy Drinking Days Per Week for Dutasteride vs. Placebo Groups
|
-2.24 Heavy Drinking Days per week
Standard Error 0.33
|
-1.41 Heavy Drinking Days per week
Standard Error 0.28
|
PRIMARY outcome
Timeframe: 12 weeks (from initiation to end of treatment phase 1)Population: Participants who attended and provided outcome data for at least one study visit following baseline session.
Change in the number of drinks per week during treatment phase 1 of study (week 1-12). The values listed in the outcome table are the average drinks per week for the last 4 weeks of treatment (week 9-12). The generalized linear mixed model analysis considered all data from the ITT sample (75 dutasteride and 80 placebo participants)
Outcome measures
| Measure |
Dutasteride
n=75 Participants
two 0.5 mg capsules of dutasteride daily
|
Placebo Capsule
n=80 Participants
inactive placebo matched in appearance with dutasteride capsules
|
|---|---|---|
|
Change in Drinks Per Week in Dutasteride vs. Placebo Groups
|
-14.16 Drinks per week
Standard Error 2.49
|
-7.72 Drinks per week
Standard Error 2.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks (week 13 to end of treatment phase 2, week 24)Population: Phase 2 (wk13-24) completers. The generalized linear mixed model analysis considered all data from the phase 2 ITT sample (phase 1 non-responders with \<60% reduction in drinks per week (49 phase 1 dutasteride-phase 2 naltrexone and 59 phase 1 placebo-phase 2 dutasteride participants).
The number of heavy drinking days per week (i.e., four or more drinks in a day for women and five or more drinks in a day for men) for phase 1 non-responders (\<60% reduction in drinks per week) during phase 2 comparing naltrexone 50 mg and dutasteride 1 mg daily. The values listed in outcome table are the mean change in HDD per week for the last 4 weeks (wk 21-24) of phase 2 relative to drinking at beginning of phase 2 treatment. treatment.
Outcome measures
| Measure |
Dutasteride
n=44 Participants
two 0.5 mg capsules of dutasteride daily
|
Placebo Capsule
n=53 Participants
inactive placebo matched in appearance with dutasteride capsules
|
|---|---|---|
|
Change in Heavy Drinking Days Per Week for Phase 2 Naltrexone vs Dutasteride Groups
|
-1.45 Heavy drinking days per week
Standard Error 0.26
|
-0.54 Heavy drinking days per week
Standard Error 0.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks (week 13 to end of treatment phase 2, week 24)Population: Phase 2 completers (wk 13-24). The generalized linear mixed model analysis considered all data from the phase 2 ITT sample (phase 1 non-responders. 49 phase 1 dutasteride-phase 2 naltrexone and 59 phase 1 placebo-phase 2 dutasteride participants).
The number of drinks per week for phase 1 non-responders (\<60% reduction in drinks per week) during phase 2 comparing naltrexone 50 mg and dutasteride 1 mg daily. The values listed in outcome table are the mean change in drinks per week for the last 4 weeks (wk 21-24) relative to drinking at beginning of phase 2 treatment.
Outcome measures
| Measure |
Dutasteride
n=44 Participants
two 0.5 mg capsules of dutasteride daily
|
Placebo Capsule
n=53 Participants
inactive placebo matched in appearance with dutasteride capsules
|
|---|---|---|
|
Change in Drinks Per Week in Phase 2 Naltrexone vs. Dutasteride Groups
|
-7.29 drinks per week
Standard Error 1.37
|
-5.31 drinks per week
Standard Error 1.48
|
Adverse Events
Dutasteride
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo Capsule
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Dutasteride - Naltrexone
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo - Dutasteride
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dutasteride
n=75 participants at risk
two 0.5 mg capsules of dutasteride daily for 12 weeks
|
Placebo Capsule
n=80 participants at risk
inactive placebo matched in appearance with dutasteride capsules for 12 weeks
|
Dutasteride - Naltrexone
n=49 participants at risk
Phase 1 (week 1-12) dutasteride arm participants with \<60% reduction in drinks per week assigned to naltrexone 50 mg daily for Phase 2 (weeks 13-24)
|
Placebo - Dutasteride
n=59 participants at risk
Phase 1 (week 1-12) placebo arm participants with \<60% reduction in drinks per week assigned to dutasteride 1mg daily for Phase 2 (weeks 13-24)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/75 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
0.00%
0/80 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
0.00%
0/49 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
1.7%
1/59 • Number of events 1 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
|
Injury, poisoning and procedural complications
fall from step ladder
|
0.00%
0/75 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
0.00%
0/80 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
0.00%
0/49 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
1.7%
1/59 • Number of events 1 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
Other adverse events
| Measure |
Dutasteride
n=75 participants at risk
two 0.5 mg capsules of dutasteride daily for 12 weeks
|
Placebo Capsule
n=80 participants at risk
inactive placebo matched in appearance with dutasteride capsules for 12 weeks
|
Dutasteride - Naltrexone
n=49 participants at risk
Phase 1 (week 1-12) dutasteride arm participants with \<60% reduction in drinks per week assigned to naltrexone 50 mg daily for Phase 2 (weeks 13-24)
|
Placebo - Dutasteride
n=59 participants at risk
Phase 1 (week 1-12) placebo arm participants with \<60% reduction in drinks per week assigned to dutasteride 1mg daily for Phase 2 (weeks 13-24)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.7%
8/75 • Number of events 18 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
6.2%
5/80 • Number of events 8 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
22.4%
11/49 • Number of events 20 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
10.2%
6/59 • Number of events 12 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle or body ache
|
10.7%
8/75 • Number of events 10 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
8.8%
7/80 • Number of events 8 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
18.4%
9/49 • Number of events 33 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
3.4%
2/59 • Number of events 8 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Itching
|
9.3%
7/75 • Number of events 12 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
5.0%
4/80 • Number of events 6 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
4.1%
2/49 • Number of events 2 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
3.4%
2/59 • Number of events 3 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
|
Nervous system disorders
Headache
|
8.0%
6/75 • Number of events 12 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
3.8%
3/80 • Number of events 4 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
8.2%
4/49 • Number of events 13 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
5.1%
3/59 • Number of events 13 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
|
General disorders
Dizzy or lightheaded
|
8.0%
6/75 • Number of events 8 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
7.5%
6/80 • Number of events 10 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
8.2%
4/49 • Number of events 4 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
6.8%
4/59 • Number of events 9 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
|
Nervous system disorders
Numbness or Tingling around Mouth, Fingers, or Toes
|
8.0%
6/75 • Number of events 9 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
7.5%
6/80 • Number of events 17 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
2.0%
1/49 • Number of events 1 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
3.4%
2/59 • Number of events 6 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
|
Reproductive system and breast disorders
Decreased libido
|
6.7%
5/75 • Number of events 21 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
3.8%
3/80 • Number of events 5 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
2.0%
1/49 • Number of events 3 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
3.4%
2/59 • Number of events 9 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
|
Psychiatric disorders
Irritability
|
6.7%
5/75 • Number of events 11 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
3.8%
3/80 • Number of events 3 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
0.00%
0/49 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
0.00%
0/59 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
|
General disorders
Fatigue
|
2.7%
2/75 • Number of events 7 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
6.2%
5/80 • Number of events 10 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
10.2%
5/49 • Number of events 10 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
5.1%
3/59 • Number of events 7 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
|
Nervous system disorders
Difficulty sleeping
|
5.3%
4/75 • Number of events 7 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
2.5%
2/80 • Number of events 7 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
10.2%
5/49 • Number of events 13 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
15.3%
9/59 • Number of events 30 • Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place