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Dutasteride Treatment for the Reduction of Heavy Drinking in Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01758523
Recruitment Status : Active, not recruiting
First Posted : January 1, 2013
Last Update Posted : June 21, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Alcoholism Alcohol Abuse Alcohol Dependence Drug: Dutasteride Drug: sugar pill Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dutasteride Treatment for the Reduction of Heavy Drinking
Study Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Drinks per week and heavy drinking days per week [ Time Frame: up to 6-months post-treatment ]
    Heavy drinking day defined as drinking 5 or more drinks for men.

Secondary Outcome Measures :
  1. Moderation of treatment effect by genetic variation in AKR1C3 [ Time Frame: 12 weeks during active treatment phase; 2-, 4-, and 6-month post-treatment ]
    Examine primary outcome data for a drug x genotype interaction focusing on neuroactive steroid metabolism enzyme 3a-HSD(17B-HSD)

  2. 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 ]
    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

  3. Severity of alcohol-related problems [ Time Frame: 12 weeks during active treatment phase; 2-, 4-, and 6-month post-treatment ]
    As measured by the Short Inventory of Problems; SIP

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758523

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Jonathan Covault, M.D., PhD. UConn Health
More Information

Responsible Party: Jonathan Covault, Professor of Psychiatry, UConn Health
ClinicalTrials.gov Identifier: NCT01758523     History of Changes
Other Study ID Numbers: 13-056-2
2P60AA003510 ( U.S. NIH Grant/Contract )
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Jonathan Covault, UConn Health:
neuroactive steroids

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs