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Dutasteride Treatment for the Reduction of Heavy Drinking in Men

Primary Purpose

Alcoholism, Alcohol Abuse, Alcohol Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dutasteride
sugar pill
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring neuroactive steroids

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dutasteride

Sugar Pill

Arm Description

4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.

Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.

Outcomes

Primary Outcome Measures

Heavy Drinking Days Per Week
Number of days / study week with 5 or more drinks consumed
Drinks Per Week
Total number of drinks aggregated by week
Number of Participants With no Heavy Drinking Days
Number of participants with no heavy drinking days (days with 5 or more drinks) during the last 4 weeks of treatment.
Number of Participants With no Hazardous Drinking
Number of participants with no hazardous drinking (not more than 4 drinks on one day and not more than 14 drinks per week) during the last 4 weeks of treatment.

Secondary Outcome Measures

HDD/ Week by Treatment Group and AKR1C3*2 Genotype
Change in Number of days / week with 5 or more drinks consumed contrasting AKR1C3*2 CC vs. G-carrier genotype and treatment group
Carbohydrate-deficient Transferrin
Carbohydrate-deficient transferrin (CDT) at end of treatment as percentage of baseline. Serum CDT is a biochemical measure of heavy alcohol use.

Full Information

First Posted
December 24, 2012
Last Updated
April 11, 2019
Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01758523
Brief Title
Dutasteride Treatment for the Reduction of Heavy Drinking in Men
Official Title
Dutasteride Treatment for the Reduction of Heavy Drinking
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Abuse, Alcohol Dependence
Keywords
neuroactive steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dutasteride
Arm Type
Experimental
Arm Description
4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Dutasteride
Other Intervention Name(s)
Avodart
Intervention Type
Drug
Intervention Name(s)
sugar pill
Other Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Heavy Drinking Days Per Week
Description
Number of days / study week with 5 or more drinks consumed
Time Frame
12-week treatment period
Title
Drinks Per Week
Description
Total number of drinks aggregated by week
Time Frame
12-week treatment period
Title
Number of Participants With no Heavy Drinking Days
Description
Number of participants with no heavy drinking days (days with 5 or more drinks) during the last 4 weeks of treatment.
Time Frame
Last 4 weeks of treatment
Title
Number of Participants With no Hazardous Drinking
Description
Number of participants with no hazardous drinking (not more than 4 drinks on one day and not more than 14 drinks per week) during the last 4 weeks of treatment.
Time Frame
Last 4 weeks of treatment
Secondary Outcome Measure Information:
Title
HDD/ Week by Treatment Group and AKR1C3*2 Genotype
Description
Change in Number of days / week with 5 or more drinks consumed contrasting AKR1C3*2 CC vs. G-carrier genotype and treatment group
Time Frame
12-week treatment period
Title
Carbohydrate-deficient Transferrin
Description
Carbohydrate-deficient transferrin (CDT) at end of treatment as percentage of baseline. Serum CDT is a biochemical measure of heavy alcohol use.
Time Frame
end of 12-week treatment vs. baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Covault, M.D., PhD.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

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Dutasteride Treatment for the Reduction of Heavy Drinking in Men

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