Dutasteride Treatment for the Reduction of Heavy Drinking in Men
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcoholism Alcohol Abuse Alcohol Dependence |
Drug: Dutasteride Drug: sugar pill |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Dutasteride Treatment for the Reduction of Heavy Drinking |
- Drinks per week and heavy drinking days per week [ Time Frame: up to 6-months post-treatment ] [ Designated as safety issue: No ]Heavy drinking day defined as drinking 5 or more drinks for men.
- Moderation of treatment effect by genetic variation in AKR1C3 [ Time Frame: 12 weeks during active treatment phase; 2-, 4-, and 6-month post-treatment ] [ Designated as safety issue: No ]Examine primary outcome data for a drug x genotype interaction focusing on neuroactive steroid metabolism enzyme 3a-HSD(17B-HSD)
- Moderation of treatment effect by genetic variation in SRD5A1 and SRD5A2 [ Time Frame: 12 weeks during active treatment phase; 2-, 4-, and 6-month post-treatment ] [ Designated as safety issue: No ]Examine primary outcome data for a drug x genotype interaction focusing on neuroactive steroid metabolism enzyme 5a-reductase type 1 and 2 which are inhibited by dutasteride
- Severity of alcohol-related problems [ Time Frame: 12 weeks during active treatment phase; 2-, 4-, and 6-month post-treatment ] [ Designated as safety issue: No ]As measured by the Short Inventory of Problems; SIP
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: dutasteride
4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.
|
Drug: Dutasteride
Other Name: Avodart
|
|
Placebo Comparator: Sugar Pill
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
Other Name: placebo
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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 a single antidepressant (with stable dose for at least 4 weeks), a non-benzodiazepine sleep medication or a low dose of benzodiazepine equivalent to 1 mg clonazepam or lorazepam per day;
- are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug
Contacts and Locations| Contact: Oluwanisola Odesina, M.A. | 860-679-8931 | oodesina@uchc.edu |
| Contact: Paula Gendreau, B.S. | 860-679-8074 | gendreau@nso.uchc.edu |
| United States, Connecticut | |
| University of Connecticut Health Center | Recruiting |
| Farmington, Connecticut, United States, 06030 | |
| Contact: Oluwanisola Odesenia, M.A. 860-679-8931 oodesina@uchc.edu | |
| Principal Investigator: Jonathan Covault, MD, PhD | |
| Sub-Investigator: Cheryl Oncken, MD, MPH | |
| Sub-Investigator: Howard Tennen, PhD | |
| Principal Investigator: | Jonathan Covault, M.D., PhD. | University of Connecticut Health Center |
More Information
No publications provided
| Responsible Party: | Jonathan Covault, Professor of Psychiatry, University of Connecticut Health Center |
| ClinicalTrials.gov Identifier: | NCT01758523 History of Changes |
| Other Study ID Numbers: | 13-056-2, 2P60AA003510 |
| Study First Received: | December 24, 2012 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Connecticut Health Center:
|
neuroactive steroids |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Dutasteride |
5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013