Dutasteride Treatment for the Reduction of Heavy Drinking in Men

NCT ID: NCT01758523

Last Updated: 2019-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-02-28

Brief Summary

This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.

Detailed Description

Extensive preclinical studies indicate that neuroactive steroids medicate important effects of alcohol and support the examination of neuroactive steroid modulators as treatment options for alcohol use problems. Dutasteride, a widely prescribed medication for benign prostatic hypertrophy, blocks a key step in the production of neuroactive steroids and represents a promising candidate for treatment of alcohol use disorders. This study will use a 12-week randomized placebo controlled design to examine the safety and efficacy of dutasteride to reduce drinking among a sample of 160 men with hazardous levels of alcohol use. It will additionally examine the potential moderation of dutasteride treatment effects by a common missense polymorphism in a neuroactive steroid biosynthetic enzyme that we have previously reported to be associated with alcohol dependence. Identification of genetic predictors of medication response offers the potential for matching alcohol treatment medications with those most likely to respond.

Conditions

Alcoholism; Alcohol Abuse; Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dutasteride

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

Group Type: EXPERIMENTAL

Dutasteride

Intervention Type: DRUG

Sugar Pill

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

Group Type: PLACEBO_COMPARATOR

sugar pill

Intervention Type: DRUG

Interventions

Dutasteride

Intervention Type: DRUG

sugar pill

Intervention Type: DRUG

Other Intervention Names

Avodart; placebo

Eligibility Criteria

Inclusion Criteria

• an average weekly ethanol consumption of at least 24 standard drinks;
• be able to read English at the 8th grade or higher level;
• no evidence of significant cognitive impairment;
• be willing to provide signed, informed consent to participate in the study (including a willingness to stop or reduce drinking to non-hazardous levels);
• be willing to nominate an individual who will know the patient's whereabouts to facilitate follow up during the study

Exclusion Criteria

• history of significant alcohol withdrawal symptoms (e.g. substantial tremor, autonomic changes, perceptual distortions, seizures, delirium, or hallucinations);
• current Diagnostic and Statistical Manual Version IV (DSM-IV) 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 study (e.g. evidence of serious adverse medical or psychiatric effects that are exacerbated by heavy drinking and would, for safety reasons, lead the physician to urge the patient to be totally abstinent and engage in an empirically supported treatment).
• current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation,(we will not exclude patients with hypertension, diabetes mellitus, asthma or other common medical conditions, if these are adequately controlled and the patient has an ongoing relationship with a primary care provider)
• serious psychiatric illness on the basis of history or psychiatric examination (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mental disorder, current clinically significant eating disorder, or substantial suicide or violence risk);
• current DSM-IV diagnosis of drug dependence (other than nicotine dependence);
• currently taking psychotropics other than medication for depression/anxiety disorder (with stable dose for at least 4 weeks),medications for treatment of Attention Deficit/Hyperactivity Disorder (with stable dose for at least 4 weeks), a non-benzodiazepine sleep medication or a low dose of benzodiazepine equivalent to 2 mg clonazepam or lorazepam per day;
• are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Covault

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Covault, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Countries

United States

References

Covault J, Tennen H, Feinn R. Randomized Placebo-Controlled Clinical Trial of Dutasteride for Reducing Heavy Drinking in Men. J Clin Psychopharmacol. 2024 May-Jun 01;44(3):223-231. doi: 10.1097/JCP.0000000000001849.

Reference Type: DERIVED

PMID: 38684046 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2P60AA003510

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-056-2

Identifier Type: -

Identifier Source: org_study_id