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Dutasteride Treatment for the Reduction of Heavy Drinking in Men

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Connecticut Health Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonathan Covault, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01758523
First received: December 24, 2012
Last updated: October 14, 2014
Last verified: October 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 a single 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) or 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758523

Contacts
Contact: Oluwanisola Odesina, M.A. 860-679-8931 oodesina@uchc.edu
Contact: Kathleen Curley, B.S. 860-679-2633 kcurley@uchc.edu

Locations
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         
Sub-Investigator: Anne Kenny, MD         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
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: October 14, 2014
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
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 27, 2014