Clinical trial NCT01758523: Dutasteride Treatment for the Reduction of Heavy Drinking in Men
Official title: Dutasteride Treatment for the Reduction of Heavy Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Alcohol Abuse
Alcohol Dependence
Keywords: neuroactive steroids
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2013-01-01
Enrollment: 189
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Heavy Drinking Days Per Week
timeFrame: 12-week treatment period
measure: Drinks Per Week
timeFrame: 12-week treatment period
measure: Number of Participants With no Heavy Drinking Days
timeFrame: Last 4 weeks of treatment
measure: Number of Participants With no Hazardous Drinking
timeFrame: Last 4 weeks of treatment
Secondary outcomes:
measure: HDD/ Week by Treatment Group and AKR1C3*2 Genotype
timeFrame: 12-week treatment period
measure: Carbohydrate-deficient Transferrin
timeFrame: end of 12-week treatment vs. baseline
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Jonathan Covault, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References: