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Trial record 10 of 117 for:    DUTASTERIDE
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Dutasteride for the Reduction of Alcohol Use in Male Drinkers

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ClinicalTrials.gov Identifier: NCT01262287
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : February 10, 2017
Last Update Posted : March 20, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jonathan Covault, UConn Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alcoholism
Alcohol Abuse
Alcohol Dependence
Interventions Drug: Dutasteride
Drug: Placebo
Enrollment 47
Recruitment Details  
Pre-assignment Details 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
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description

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 daily for 8-week treatment period

placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
Period Title: Overall Study
Started 20 19
Completed 18 18
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Arm/Group Title Dutasteride Placebo Total
Hide Arm/Group Description

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 daily for 8-week treatment period

placebo: placebo capsules in same number as active drug, daily for 8-week treatment period

 Total of all reporting groups
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  95.0%
17
  89.5%
36
  92.3%
>=65 years
1
   5.0%
2
  10.5%
3
   7.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 39 participants
50.95  (10.21) 54.95  (7.44) 52.90  (9.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
19
 100.0%
39
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Hispanic or Latino
1
   5.0%
1
   5.3%
2
   5.1%
Not Hispanic or Latino
19
  95.0%
18
  94.7%
37
  94.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.0%
1
   5.3%
2
   5.1%
White
18
  90.0%
18
  94.7%
36
  92.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.0%
0
   0.0%
1
   2.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 19 participants 39 participants
20 19 39
1.Primary Outcome
Title Change Number of Standard Drinks Per Week.
Hide Description 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
Time Frame Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:

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 daily for 8-week treatment period

placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
Overall Number of Participants Analyzed 18 18
Mean (Standard Error)
Unit of Measure: standard drinks per week
-26.2  (4.6) -25.5  (4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Change in Standard Drinks Per Week - Moderation by Genetic Variation
Hide Description 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)
Time Frame Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AKR1C3*2 C/C Genotype + Dutasteride AKR1C3*2 C/C Genotype + Placebo AKR1C3*2 G-carriers + Dutasteride AKR1C3*2 G-carriers + Placebo
Hide Arm/Group Description:
AKR1C3*2 C/C genotype subjects in dutasteride arm (1 mg daily for 8 wks)

AKR1C3*2 C/C genotype subjects in placebo arm

placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
AKR1C3*2 G-carriers in dutasteride arm (1 mg/day x 8 wks)
AKR1C3*2 G-carriers in placebo arm
Overall Number of Participants Analyzed 8 5 10 13
Mean (Standard Error)
Unit of Measure: standard drinks per week
-32.4  (5.4) -31.2  (13.9) 21.8  (6.9) -22.3  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AKR1C3*2 C/C Genotype + Dutasteride, AKR1C3*2 C/C Genotype + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AKR1C3*2 G-carriers + Dutasteride, AKR1C3*2 G-carriers + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description

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 daily for 8-week treatment period

placebo: placebo capsules in same number as active drug, daily for 8-week treatment period
All-Cause Mortality
Dutasteride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dutasteride Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dutasteride Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/20 (55.00%)      9/19 (47.37%)    
Gastrointestinal disorders     
Stomach discomfort *  4/20 (20.00%)  4 1/19 (5.26%)  1
Nausea *  1/20 (5.00%)  1 0/19 (0.00%)  0
General disorders     
Tiredness *  2/20 (10.00%)  2 2/19 (10.53%)  4
change in sleep *  3/20 (15.00%)  14 3/19 (15.79%)  6
lightheadness/dizziness *  1/20 (5.00%)  4 1/19 (5.26%)  3
Musculoskeletal and connective tissue disorders     
Muscle or joint ache *  1/20 (5.00%)  1 1/19 (5.26%)  6
Nervous system disorders     
Headache *  2/20 (10.00%)  2 0/19 (0.00%)  0
Reproductive system and breast disorders     
Reduced libido *  2/20 (10.00%)  6 3/19 (15.79%)  9
Impotence *  0/20 (0.00%)  0 1/19 (5.26%)  5
gynecomastia *  1/20 (5.00%)  2 0/19 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
28% of participants were abstinent for the entire 8-week medication treatment period which reduced ability to detect the hypothesized treatment effects of dutasteride related to alcohol's acute effects on neuroactive steroid production.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jonathan Covault
Organization: University of Connecticut School of Medicine
Phone: 860-679-7560
EMail: jocovault@uchc.edu
Layout table for additonal information
Responsible Party: Jonathan Covault, UConn Health
ClinicalTrials.gov Identifier: NCT01262287     History of Changes
Other Study ID Numbers: 11-036-2
P60AA003510 ( U.S. NIH Grant/Contract )
First Submitted: December 15, 2010
First Posted: December 17, 2010
Results First Submitted: December 17, 2016
Results First Posted: February 10, 2017
Last Update Posted: March 20, 2017