Dutasteride Treatment for the Reduction of Heavy Drinking in Men

Completed · Phase 4 · Has a placebo group

Conditions studied: Alcoholism, Alcohol Abuse, Alcohol Dependence

In brief

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

Key facts

Study ID

NCT01758523

Run by

UConn Health

People needed

189

Starts

2013-01-01

Expected to finish

2018-02-28

Last updated by the study team

2019-04-26

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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