Dutasteride Treatment for the Reduction of Heavy Drinking in Men

Condition(s) targeted: Alcoholism; Alcohol Abuse; Alcohol Dependence

Intervention: Dutasteride (Drug); sugar pill (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Connecticut Health Center

Official(s) and/or principal investigator(s):
Jonathan Covault, M.D., PhD., Principal Investigator, Affiliation: University of Connecticut Health Center

Overall contact:
Oluwanisola Odesina, M.A., Phone: 860-679-8931, Email: oodesina@uchc.edu

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

Official title: Dutasteride Treatment for the Reduction of Heavy Drinking

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Drinks per week and heavy drinking days per week

Secondary outcome:

Moderation of treatment effect by genetic variation in AKR1C3

Moderation of treatment effect by genetic variation in SRD5A1 and SRD5A2

Severity of alcohol-related problems

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- an average weekly ethanol consumption of >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 or of prior need for inpatient treatment of alcohol withdrawal);

- current 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

Oluwanisola Odesina, M.A., Phone: 860-679-8931, Email: oodesina@uchc.edu

University of Connecticut Health Center, Farmington, Connecticut 06030, United States; Recruiting
Oluwanisola Odesenia, M.A., Phone: 860-679-8931, Email: oodesina@uchc.edu
Jonathan Covault, MD, PhD, Principal Investigator
Cheryl Oncken, MD, MPH, Sub-Investigator
Howard Tennen, PhD, Sub-Investigator
Anne Kenny, MD, Sub-Investigator

Starting date: January 2013
Last updated: March 2, 2015