Dutasteride for the Reduction of Alcohol Use in Male Drinkers

NCT01262287 | Completed Phase 4 Results

• 2 other identifiers: 11-036-2P60AA003510
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism; Alcohol Abuse; Alcohol Dependence

Keywords

Randomized Trial; Medication for Heavy Drinking; Dutasteride Treatment

Outcome Measures

Primary Outcomes (1)

• Change Number of Standard Drinks Per Week.

  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

  Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)

Secondary Outcomes (1)

• Change in Standard Drinks Per Week - Moderation by Genetic Variation

  Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)

Study Arms (2)

dutasteride

EXPERIMENTAL

dutasteride (1 mg oral daily dose) for 8-week treatment period

Drug: Dutasteride

Placebo

PLACEBO COMPARATOR

placebo daily for 8-week treatment period

Drug: Placebo

Interventions

Dutasteride DRUG

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

Also known as: Avodart

dutasteride

Placebo DRUG

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

Also known as: Lactose

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Dutasteride; Lactose

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Jonathan Covault
• Organization: University of Connecticut School of Medicine

jocovault@uchc.edu

860-679-7560

Study Officials

• Jonathan Covault, MD, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 20, 2017
• Results First Posted: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)