Dutasteride for the Reduction of Alcohol Use in Male Drinkers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonathan Covault, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01262287
First received: December 15, 2010
Last updated: December 24, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. The investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will result in a greater reduction in the amount of alcohol consumed per day and the frequency of heavy drinking days. The study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis and provide an estimate of likely effect sizes in order to design a more definitive study.


Condition Intervention Phase
Alcoholism
Alcohol Abuse
Alcohol Dependence
Drug: Dutasteride
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo Controlled Pilot Study of Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Heavy drinking days and number of standard drinks per week. [ Time Frame: 8-week treatment period and 16-week post-treatment follow-up ] [ Designated as safety issue: No ]
    Heavy drinking days are those for which 5 or more standardized alcohol drinks are consumed during a single day.


Secondary Outcome Measures:
  • Moderation of drug effect by genetic variation [ Time Frame: 8-week treatment and 16-week post-treatment followup periods ] [ Designated as safety issue: No ]
    Moderation of primary outcome measures by genetic variation in neuroactive steroid biosynthetic enzyme genes

  • Medication safety and tolerability [ Time Frame: 8-week treatment phase and 2 month followup ] [ Designated as safety issue: Yes ]
    Comparisons will be conducted on 1) the number of patients in each of the two groups who report adverse effects, 2) the number of patients in each of the two groups who report moderate-to-severe adverse effects, and 3) the number of patients in each group who discontinue treatment due to adverse effects. Individual adverse events that occur in > 3% of patients in either medication condition will be examined using chi-square analysis.


Enrollment: 47
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dutasteride
dutasteride (1 mg oral daily dose) for 8-week treatment period
Drug: Dutasteride
dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period
Other Name: Avodart
Placebo Comparator: Placebo
placebo daily for 8-week treatment period
Drug: placebo
placebo capsules in same number as active drug, daily for 8-week treatment period

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male outpatients age 18 to 65 years
  • Have an average weekly ethanol consumption of >24 standard drinks
  • Be able to read English at the 8th grade or higher level and show no evidence of significant cognitive impairment
  • Be willing to nominate an individual who will know the patient's whereabouts in order to facilitate follow up during the study
  • Be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels)

Exclusion Criteria:

  • Have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
  • Have a serious psychiatric illness (e.g., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mood or mental disorders, current eating disorder symptoms, or substantial suicide or violence risk) on the basis of history or psychiatric examination
  • Have a current diagnosis of drug dependence (other than nicotine or alcohol dependence)
  • Have a current diagnosis of alcohol dependence who on clinical examination by a physician, are deemed to be too severely alcohol dependent to permit them to participate in a placebo-controlled pilot study
  • Have a history of hypersensitivity to dutasteride
  • Current or past 4 month use of finasteride (Propecia), dutasteride (Avodart) or testosterone
  • Are currently taking psychotropics other than a single antidepressant with stable dose for at least 4 weeks or a non-benzodiazepine sleep medication
  • Are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262287

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Jonathan Covault, MD, PhD University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Jonathan Covault, Professor of Psychiatry, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01262287     History of Changes
Other Study ID Numbers: 11-036-2, P60AA003510
Study First Received: December 15, 2010
Last Updated: December 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Connecticut Health Center:
Randomized Trial
Medication for Heavy Drinking
Dutasteride Treatment

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014