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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:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 week. 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 or disease Intervention/treatment Phase
Alcoholism Alcohol Abuse Alcohol Dependence Drug: Dutasteride Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo Controlled Pilot Study of Dutasteride for the Reduction of Alcohol Use in Male Drinkers
Study Start Date : January 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Dutasteride
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Other Name: Lactose


Outcome Measures

Primary Outcome Measures :
  1. Change Number of Standard Drinks Per Week. [ 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) ]
    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


Secondary Outcome Measures :
  1. Change in Standard Drinks Per Week - Moderation by Genetic Variation [ 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) ]
    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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262287


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Jonathan Covault, MD, PhD UConn Health
More Information

Responsible Party: Jonathan Covault, Professor of Psychiatry, UConn Health
ClinicalTrials.gov Identifier: NCT01262287     History of Changes
Other Study ID Numbers: 11-036-2
P60AA003510 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2010    Key Record Dates
Results First Posted: February 10, 2017
Last Update Posted: March 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jonathan Covault, UConn Health:
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
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs