Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy

NCT04098302 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 19-147-2P50AA027055
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of dutasteride in reducing drinking and heavy drinking in men and women with alcohol use disorder. The investigators hypothesize that dutasteride 1 mg per day will be well tolerated in this patient population and that, compared to placebo treatment, dutasteride will result in a greater reduction in drinks per week and in the frequency of heavy drinking days.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Heavy Drinking Days Per Week for Dutasteride vs. Placebo Groups

  The number of heavy drinking days per week (i.e., four or more drinks in a day for women and five or more drinks in a day for men). The values listed in outcome table are the average HDD per week for the last 4 weeks (9-12) of phase 1 treatment. The generalized linear mixed model analysis considered all data from the ITT sample (75 dutasteride and 80 placebo participants)

  12 weeks (from initiation to end of treatment phase 1)

• Change in Drinks Per Week in Dutasteride vs. Placebo Groups

  Change in the number of drinks per week during treatment phase 1 of study (week 1-12). The values listed in the outcome table are the average drinks per week for the last 4 weeks of treatment (week 9-12). The generalized linear mixed model analysis considered all data from the ITT sample (75 dutasteride and 80 placebo participants)

  12 weeks (from initiation to end of treatment phase 1)

Other Outcomes (2)

• Change in Heavy Drinking Days Per Week for Phase 2 Naltrexone vs Dutasteride Groups

  12 weeks (week 13 to end of treatment phase 2, week 24)

• Change in Drinks Per Week in Phase 2 Naltrexone vs. Dutasteride Groups

  12 weeks (week 13 to end of treatment phase 2, week 24)

Study Arms (2)

dutasteride

ACTIVE COMPARATOR

two 0.5 mg capsules of dutasteride daily

Drug: Dutasteride Capsules

placebo capsule

PLACEBO COMPARATOR

inactive placebo matched in appearance with dutasteride capsules

Drug: Placebo Capsules

Interventions

Dutasteride Capsules DRUG

1 mg/day oral dutasteride (2 x 0.5 mg capsules)

Also known as: Avodart

dutasteride

Placebo Capsules DRUG

Placebo capsules with matching appearance as Dutasteride Capsules

Also known as: inactive placebo

placebo capsule

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women age 35 to 70 yo inclusive
• have an average weekly ethanol consumption of \>24 SD for men and \>18 for women and at least 2 HDD/wk over the 8 weeks prior to screening
• current DSM-5 AUD
• no evidence of significant cognitive impairment
• for women of child-bearing potential (i.e., no hysterectomy, bilateral oophorectomy, or tubal ligation; or \<2 years postmenopausal) must be non-lactating, practicing a reliable method of birth control and agree to continue such throughout the study and for 6 months following participation, and have a negative serum pregnancy test prior to initiation of treatment.

You may not qualify if:

• history of serious alcohol withdrawal symptoms (e.g., perceptual distortions, seizures, delirium, or hallucinations)
• subjects who on clinical examination by a physician are deemed to be too severely alcohol dependent to permit them to participate in a pbo-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, including direct bilirubin more than 2.5 times the upper limit of normal or transaminase elevations 5 times the upper limit of normal (the investigators will not exclude patients with hypertension, diabetes, asthma or other common medical conditions, if these are adequately controlled and the patient has an ongoing relationship with a primary care provider)
• have a serious psychiatric illness on the basis of history or psychiatric examination (i.e., schizophrenia, active clinically significant mood episode of bipolar disorder or major depression, organic mental disorder, current clinically significant eating disorder, or substantial suicide or violence risk)
• have a current DSM-5 diagnosis of moderate drug use disorder (other than caffeine or nicotine dependence)
• currently taking finasteride, dutasteride, medication for treatment of AUD, or chronic use of opioid pain medication
• are considered by the investigators to be an unsuitable candidate for an investigational drug

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jonathan Covault Study PI
• Organization: UConn Health

jocovault@uchc.edu

860-679-7560

Study Officials

• Jonathan Covault, MD, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: UConn Health Investigational Pharmacy will randomize to dutasteride vs. placebo for phase 1 at baseline
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study consists of two 12-week phases, the first being a 12-week parallel-groups comparison of dutasteride and placebo to evaluate the safety and efficacy of dutasteride 1 mg/day in reducing the likelihood of drinking and heavy drinking in treatment-seeking men and women with alcohol use disorder. In the second 12-week phase, responders in phase 1 (defined as a ≥60% reduction in SD/wk for weeks 9-12 compared with screening) will continue on their initial medication assignment, while non-responder subjects treated with placebo in phase 1 will be given dutasteride during phase 2, and non-responder subjects treated with dutasteride in phase 1 will receive naltrexone daily in phase 2. This design maintains double blind conditions in both phases 1 and 2.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: October 15, 2019
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)