Dutasteride Treatment for the Reduction of Heavy Drinking in Men (NCT01758523) | Clinical Trial Compass
CompletedPhase 4
Dutasteride Treatment for the Reduction of Heavy Drinking in Men
United States189 participantsStarted 2013-01
Plain-language summary
This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.
Who can participate
Age range18 Years – 70 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 relations…
What they're measuring
1
Heavy Drinking Days Per Week
Timeframe: 12-week treatment period
2
Drinks Per Week
Timeframe: 12-week treatment period
3
Number of Participants With no Heavy Drinking Days