Exploration of Gemfibrozil as a Treatment for AUD

Study Overview
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Brief Summary
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This study will examine the efficacy of the medication gemfibrozil in reducing alcohol consumption in individuals with an alcohol use disorder who are seeking treatment for alcohol-related problems. Twenty individuals will be randomized to receive four weeks of either gemfibrozil or placebo and retrospective reports of alcohol use will be collected throughout the trial. In addition, brain imaging measures will be collected at baseline and after two weeks of treatment to determine the effects of gemfibrozil on brain functioning.

Official Title
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Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Gemfibrozil 600 MG
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males and females age 18-60 meeting DSM-V criteria for moderate or severe AUD in the past year interested in cutting down or quitting drinking able to provide voluntary informed consent have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in the past 30 days Exclusion Criteria: severe liver disease; severe kidney disease; gallbladder disease or gallstones chronic renal or hepatic failure recent pancreatitis insulin-dependent diabetes other urgent medical problems moderately elevated liver function tests (AST or ALT greater than 2 times upper limit of normal) or elevated creatine kinase (CK) schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the last month current moderate or severe other substance use disorder (SUD; except nicotine or marijuana) active legal problems with the potential to result in incarceration pregnancy or lactation, or child bearing age and not on birth control or not willing to use other birth control methods (e.g. condoms) current daily use of anti-craving medications, mood stabilizers, benzodiazepines, or anti-psychotics regularly taking a medication contraindicated for use with gemfibrozil including other fibrates, statins, repaglinide, or which are believed to interact with gemfibrozil such as dasabuvir, dabrafenib, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone, colestipol, colchicine and warfarin41,68 a history of alcohol withdrawal-induced seizures or delirium tremens (hallucinations, disorientation) requiring hospital admission during the last ten years a history of moderate or severe traumatic brain injury (TBI; loss of consciousness >30 minutes69) left-handedness any contraindications for MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemfibrozil<br>Gemfibrozil 600 mg by mouth twice daily | Drug: Gemfibrozil 600 MG<br>* Gemfibrozil capsules (600 mg) taken twice per day<br>|
| Placebo Comparator: Placebo<br>Microcrystalline cellulose powder packaged in capsules identical to the experimental condition | Drug: Placebo oral capsule<br>* Microcrystalline cellulose powder packaged in capsules identical to the experimental medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Standard Drinks Per Drinking Day | Average number of standard drinks consumed on drinking days | Baseline | 
| Mean Standard Drinks Per Drinking Day | Average number of standard drinks consumed on drinking days | 2 weeks post baseline | 
| Mean Standard Drinks Per Drinking Day | Average number of standard drinks consumed on drinking days | 4 weeks post baseline | 
| Percent Days Abstinent | Percentage of days of abstinence from alcohol | Baseline | 
| Percent Days Abstinent | Percentage of days of abstinence from alcohol | 2 weeks post baseline | 
| Percent Days Abstinent | Percentage of days of abstinence from alcohol | 4 weeks post baseline |