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Trial record 17 of 117 for:    DUTASTERIDE

Dutasteride Treatment for the Reduction of Heavy Drinking in Men

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ClinicalTrials.gov Identifier: NCT01758523
Recruitment Status : Completed
First Posted : January 1, 2013
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
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: sugar pill
Enrollment 189
Recruitment Details  
Pre-assignment Details 47 subjects not randomized: 23 excluded at in person screening visit; 24 subjects withdrew prior to randomization
Arm/Group Title Dutasteride Sugar Pill
Hide Arm/Group Description

4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.

Dutasteride

Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.

sugar pill

Period Title: Overall Study
Started 74 68
Attended >/= 1 Visit Post-randomization 68 67
Completed 53 54
Not Completed 21 14
Reason Not Completed
Adverse Event             2             1
Lack of Efficacy             4             2
Lost to Follow-up             3             4
Withdrawal by Subject             12             7
Arm/Group Title Dutasteride Sugar Pill Total
Hide Arm/Group Description

4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.

Dutasteride

Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.

sugar pill

Total of all reporting groups
Overall Number of Baseline Participants 68 67 135
Hide Baseline Analysis Population Description
Subjects who completed at least 1 visit post-randomization (modified intention to treat sample)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 67 participants 135 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
64
  94.1%
62
  92.5%
126
  93.3%
>=65 years
4
   5.9%
5
   7.5%
9
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 67 participants 135 participants
53.0  (7.9) 53.1  (9.4) 53.0  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 67 participants 135 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
68
 100.0%
67
 100.0%
135
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 67 participants 135 participants
Hispanic or Latino
1
   1.5%
0
   0.0%
1
   0.7%
Not Hispanic or Latino
67
  98.5%
67
 100.0%
134
  99.3%
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 68 participants 67 participants 135 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.5%
1
   1.5%
2
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.5%
1
   1.5%
2
   1.5%
White
66
  97.1%
65
  97.0%
131
  97.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants 67 participants 135 participants
68 67 135
Heavy Drinking Days (HDD)/wk   [1] 
Mean (Standard Deviation)
Unit of measure:  Heavy drinking days / week
Number Analyzed 68 participants 67 participants 135 participants
5.2  (2.2) 5.2  (2.1) 5.2  (2.1)
[1]
Measure Description: days/week with 5 or more drinks over the 60 days prior to screening visit
Drinks/week   [1] 
Mean (Standard Deviation)
Unit of measure:  Drinks/week
Number Analyzed 68 participants 67 participants 135 participants
48.8  (24) 47.3  (20.4) 48.0  (22.2)
[1]
Measure Description: Total standard drinks / week over 60 day prior to screening visit
AbstinentDays/week   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 68 participants 67 participants 135 participants
0.67  (1.1) 0.62  (1.1) 0.64  (1.1)
[1]
Measure Description: Days per week with no drinking during the 60 days prior to screening visit
DSM-IV Alcohol Dependence criteria   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 68 participants 67 participants 135 participants
4.3  (1.6) 4.0  (1.6) 4.2  (1.6)
[1]
Measure Description: Number of current Diagnostic and Statistical Manual (DSM-IV) criteria for alcohol dependence (0-7; higher number greater severity of dependence; >2 criteria required for diagnosis of alcohol dependence)
Short Inventory of Problems   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 68 participants 67 participants 135 participants
17.2  (8.2) 16.8  (8.8) 17.0  (8.4)
[1]
Measure Description: The Short Inventory of Problems (SIP). The SIP, is a 15-item instrument with a total score that ranges from 0 to 45, higher score worse outcomes.
Smoker   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 67 participants 135 participants
12
  17.6%
12
  17.9%
24
  17.8%
[1]
Measure Description: 5 or more cigarettes per day
1.Primary Outcome
Title Heavy Drinking Days Per Week
Hide Description Number of days / study week with 5 or more drinks consumed
Time Frame 12-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention to Treat (ITT) all subjects who attended one or more post-randomization visit.
Arm/Group Title Dutasteride Sugar Pill
Hide Arm/Group Description:

4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.

Dutasteride

Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.

sugar pill

Overall Number of Participants Analyzed 68 67
Mean (Standard Error)
Unit of Measure: heavy drinking days/week
1.75  (0.33) 2.67  (0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride, Sugar Pill
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Drinks Per Week
Hide Description Total number of drinks aggregated by week
Time Frame 12-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT (all subjects who attended one or more post-randomization visit)
Arm/Group Title Dutasteride Sugar Pill
Hide Arm/Group Description:

4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.

Dutasteride

Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.

sugar pill

Overall Number of Participants Analyzed 68 67
Mean (Standard Error)
Unit of Measure: drinks/week
22.0  (2.6) 27.2  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride, Sugar Pill
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With no Heavy Drinking Days
Hide Description Number of participants with no heavy drinking days (days with 5 or more drinks) during the last 4 weeks of treatment.
Time Frame Last 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol 12-week completer
Arm/Group Title Dutasteride Sugar Pill
Hide Arm/Group Description:

4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.

Dutasteride

Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.

sugar pill

Overall Number of Participants Analyzed 53 54
Measure Type: Count of Participants
Unit of Measure: Participants
16
  30.2%
8
  14.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride, Sugar Pill
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.49
Confidence Interval (2-Sided) 95%
0.96 to 6.45
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Participants With no Hazardous Drinking
Hide Description Number of participants with no hazardous drinking (not more than 4 drinks on one day and not more than 14 drinks per week) during the last 4 weeks of treatment.
Time Frame Last 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol 12 week treatment completers
Arm/Group Title Dutasteride Sugar Pill
Hide Arm/Group Description:

4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.

Dutasteride

Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.

sugar pill

Overall Number of Participants Analyzed 53 54
Measure Type: Count of Participants
Unit of Measure: Participants
13
  24.5%
3
   5.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride, Sugar Pill
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
1.5 to 20.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title HDD/ Week by Treatment Group and AKR1C3*2 Genotype
Hide Description Change in Number of days / week with 5 or more drinks consumed contrasting AKR1C3*2 CC vs. G-carrier genotype and treatment group
Time Frame 12-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT (all subjects who attended one or more post-randomization visit)
Arm/Group Title Dutasteride - AKR1C3*2 CC Sugar Pill - AKR1C3*2 CC Dutasteride - AKR1C3*2 G-carrier Sugar Pill - AKR1C3*2 G-carrier
Hide Arm/Group Description:
dutasteride treated AKR1C3*2 CC genotype subjects
placebo treated AKR1C3*2 CC genotype subjects
dutasteride treated AKR1C3*2 G-carrier genotype subjects
placebo treated AKR1C3*2 G-carrier genotype subjects
Overall Number of Participants Analyzed 19 25 49 42
Mean (Standard Error)
Unit of Measure: heavy drinking days/week
1.06  (0.48) 2.9  (0.53) 2.05  (0.42) 2.5  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride - AKR1C3*2 CC, Sugar Pill - AKR1C3*2 CC, Dutasteride - AKR1C3*2 G-carrier, Sugar Pill - AKR1C3*2 G-carrier
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments significance for drug x AKR1C3*2 G-carrier genotype
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Carbohydrate-deficient Transferrin
Hide Description Carbohydrate-deficient transferrin (CDT) at end of treatment as percentage of baseline. Serum CDT is a biochemical measure of heavy alcohol use.
Time Frame end of 12-week treatment vs. baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol 12-week completers (serum sample not available for 1 placebo subject).
Arm/Group Title Dutasteride Sugar Pill
Hide Arm/Group Description:

4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.

Dutasteride

Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.

sugar pill

Overall Number of Participants Analyzed 53 53
Mean (Standard Error)
Unit of Measure: percentage of baseline CDT
94  (3.8) 107  (4.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride, Sugar Pill
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Bi-weekly during 12-week active treatment then bi-monthly for 6 months
Adverse Event Reporting Description At each patient visit the study nurse used a 16-item adverse events questionnaire to screen for presence of adverse events.
 
Arm/Group Title Dutasteride Sugar Pill
Hide Arm/Group Description

4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.

Dutasteride

Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.

sugar pill

All-Cause Mortality
Dutasteride Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/67 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Dutasteride Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   4/68 (5.88%)   2/67 (2.99%) 
Infections and infestations     
Tonsillar abscess *  1/68 (1.47%)  0/67 (0.00%) 
Musculoskeletal and connective tissue disorders     
Chronic back pain   0/68 (0.00%)  1/67 (1.49%) 
Nervous system disorders     
alcohol withdrawal   2/68 (2.94%)  1/67 (1.49%) 
Respiratory, thoracic and mediastinal disorders     
COPD exacerbation   1/68 (1.47%)  0/67 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dutasteride Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   37/68 (54.41%)   27/67 (40.30%) 
Gastrointestinal disorders     
Stomach discomfort   11/68 (16.18%)  3/67 (4.48%) 
Nausea   4/68 (5.88%)  5/67 (7.46%) 
General disorders     
Headache   10/68 (14.71%)  11/67 (16.42%) 
Fatigue   5/68 (7.35%)  7/67 (10.45%) 
Sleep disturbance   5/68 (7.35%)  3/67 (4.48%) 
Musculoskeletal and connective tissue disorders     
Muscle or joint pain   11/68 (16.18%)  7/67 (10.45%) 
Reproductive system and breast disorders     
Reduced Libido   6/68 (8.82%)  0/67 (0.00%) 
Impotence   4/68 (5.88%)  2/67 (2.99%) 
Indicates events were collected by systematic assessment
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: NCT01758523     History of Changes
Other Study ID Numbers: 13-056-2
2P60AA003510 ( U.S. NIH Grant/Contract )
First Submitted: December 24, 2012
First Posted: January 1, 2013
Results First Submitted: February 25, 2019
Results First Posted: April 26, 2019
Last Update Posted: April 26, 2019