- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04098302
Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
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Connecticut
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Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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.
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: dutasteride
two 0.5 mg capsules of dutasteride daily
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1 mg/day oral dutasteride (2 x 0.5 mg capsules)
Other Names:
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Placebo Comparator: placebo capsule
inactive placebo matched in appearance with dutasteride capsules
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Placebo capsules with matching appearance as Dutasteride Capsules
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Heavy Drinking Days Per Week by Medication Group
Time Frame: 12 weeks (from initiation to end of treatment phase 1)
|
Change in the number of heavy drinking days (i.e., four or more drinks in a day for women and five or more drinks in a day for men) during treatment phase of study.
Daily drinking data will be aggregated to the weekly level.
|
12 weeks (from initiation to end of treatment phase 1)
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Change in Drinks Per Week by Medication Group
Time Frame: 12 weeks (from initiation to end of treatment phase 1)
|
Change in the number of drinks per week during treatment phase of study.
Daily drinking data will be aggregated to the weekly level.
|
12 weeks (from initiation to end of treatment phase 1)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Covault, MD, PhD, UConn Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcoholism
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- 5-alpha Reductase Inhibitors
- Dutasteride
Other Study ID Numbers
- 19-147-2
- P50AA027055 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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