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

Phase

2/3

Condition

Alcohol Use Disorder

Substance Abuse

Addictions

Treatment

Dutasteride Capsules

Placebo Capsules

Clinical Study ID

NCT04098302

19-147-2

P50AA027055

Ages 35-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

men and women age 35 to 70 yo inclusive
have an average weekly ethanol consumption of >24 SD for men and >18 for women andat 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 areliable method of birth control and agree to continue such throughout the study andfor 6 months following participation, and have a negative serum pregnancy test priorto initiation of treatment.

Exclusion

Exclusion Criteria:

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 severelyalcohol dependent to permit them to participate in a pbo-controlled study (e.g.,evidence of serious adverse medical or psychiatric effects that are exacerbated byheavy drinking and would, for safety reasons, lead the physician to urge the patientto be totally abstinent and engage in an empirically supported treatment)
current, clinically significant physical disease or abnormality on the basis ofmedical history, physical examination, or routine laboratory evaluation, includingdirect bilirubin more than 2.5 times the upper limit of normal or transaminaseelevations 5 times the upper limit of normal (the investigators will not excludepatients with hypertension, diabetes, asthma or other common medical conditions, ifthese are adequately controlled and the patient has an ongoing relationship with aprimary care provider)
have a serious psychiatric illness on the basis of history or psychiatricexamination (i.e., schizophrenia, active clinically significant mood episode ofbipolar disorder or major depression, organic mental disorder, current clinicallysignificant eating disorder, or substantial suicide or violence risk)
have a current DSM-5 diagnosis of moderate drug use disorder (other than caffeine ornicotine dependence)
currently taking finasteride, dutasteride, medication for treatment of AUD, orchronic use of opioid pain medication
are considered by the investigators to be an unsuitable candidate for aninvestigational drug

Study Design

Dutasteride Capsules

2/3

October 15, 2019

June 28, 2024

Study Description

Heavy drinking remains a significant public health problem and is frequently under treated. Although several medications have been shown to help patients stop or reduce drinking, additional medication options are needed as there is considerable variability in effectiveness or tolerability of existing medications for individual patients. Additionally, identification of individual subject level predictors of efficacy are needed to better personalize pharmacotherapy treatment recommendations. This study will seek to replicate and extend our results showing efficacy of a novel medication dutasteride for reducing drinking and will examine potential easily measured predictors of response.

Dutasteride is a widely prescribed medication for benign prostatic hypertrophy and androgenic hair loss that also modulates the elimination of cortisol and the production of some neuroactive steroids. Changes in the regulation of cortisol and neuroactive steroids have each been suggested as factors which may contribute to the maintenance of alcohol dependence. Data from a recently completed first randomized placebo controlled trial of dutasteride for AUD in a sample of male drinkers, indicates that dutasteride is well tolerated in alcoholics and has efficacy in helping subjects reduce drinking. Additionally, results indicate that dutasteride may be particularly helpful for patients who drink to cope with anxiety and negative emotions, a group of patients with poor response to other treatments.

This 24-week treatment study will use an innovative randomized placebo controlled step therapy design to examine the safety and efficacy of dutasteride to reduce drinking by treatment seeking women and men with hazardous levels of alcohol use. At 12-weeks placebo non-responders will transition to dutasteride and dutasteride non-responders will transition to naltrexone, an FDA approved medication with demonstrated efficacy for reducing heavy drinking. 12-week responders (reduction in drinks/week of 60% or greater compared with screening) will continue for an additional 12-weeks on their initial study medication assignment (dutasteride or placebo).

Additionally, the investigators will examine several baseline measures as predictors of dutasteride efficacy, including drinking to cope, anxiety, adverse child events, and perceived life stress as well as stress resilient vs. reactive genotypes of FKBP5 a chaperone protein involved in regulation of glucocorticoid, androgen and progesterone receptor function.

Connect with a study center

University of Connecticut Health Center
Farmington, Connecticut 06030
United States
Site Not Available

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