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Completed

NCT Number: NCT01262287

Dutasteride for the Reduction of Alcohol Use in Male Drinkers

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dutasteride

Drug

dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period

Other names: Avodart

Placebo

Drug

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

Other names: Lactose

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Placebo Controlled Pilot Study of Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 17, 2010
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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