Dutasteride Treatment for the Reduction of Heavy Drinking in Men

NCT01758523 | Completed Phase 4 Results

• 2 other identifiers: 13-056-22P60AA003510
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcoholism; Alcohol Abuse; Alcohol Dependence

Keywords

neuroactive steroids

Outcome Measures

Primary Outcomes (4)

• Heavy Drinking Days Per Week

  Number of days / study week with 5 or more drinks consumed

  12-week treatment period

• Drinks Per Week

  Total number of drinks aggregated by week

  12-week treatment period

• Number of Participants With no Heavy Drinking Days

  Number of participants with no heavy drinking days (days with 5 or more drinks) during the last 4 weeks of treatment.

  Last 4 weeks of treatment

• Number of Participants With no Hazardous Drinking

  Number of participants with no hazardous drinking (not more than 4 drinks on one day and not more than 14 drinks per week) during the last 4 weeks of treatment.

  Last 4 weeks of treatment

Secondary Outcomes (2)

• HDD/ Week by Treatment Group and AKR1C3*2 Genotype

  12-week treatment period

• Carbohydrate-deficient Transferrin

  end of 12-week treatment vs. baseline

Study Arms (2)

dutasteride

EXPERIMENTAL

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

Drug: Dutasteride

Sugar Pill

PLACEBO COMPARATOR

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

Drug: sugar pill

Interventions

Dutasteride DRUG

Also known as: Avodart

dutasteride

sugar pill DRUG

Also known as: placebo

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

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

Related Publications (1)

• 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.

  PMID: 38684046 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Dutasteride; Sugars

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; Carbohydrates

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, M.D., 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 24, 2012
• First Posted: January 1, 2013
• Study Start: January 1, 2013
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: April 26, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-04

Locations

US (1)