Exploration of Gemfibrozil as a Treatment for AUD
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Gemfibrozil 600 MG; Placebo oral capsule
Intervention description: Gemfibrozil capsules (600 mg) taken twice per day; Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
Intervention MeSH terms: Gemfibrozil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. males and females age 18-60 meeting DSM-V criteria for moderate or severe AUD in the
             past year

          2. interested in cutting down or quitting drinking

          3. able to provide voluntary informed consent

          4. have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in
             the past 30 days

        Exclusion Criteria:

          1. severe liver disease; severe kidney disease; gallbladder disease or gallstones

          2. chronic renal or hepatic failure

          3. recent pancreatitis

          4. insulin-dependent diabetes

          5. other urgent medical problems

          6. moderately elevated liver function tests (AST or ALT greater than 2 times upper limit
             of normal) or elevated creatine kinase (CK)

          7. schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the
             last month

          8. current moderate or severe other substance use disorder (SUD; except nicotine or
             marijuana)

          9. active legal problems with the potential to result in incarceration

         10. pregnancy or lactation, or child bearing age and not on birth control or not willing
             to use other birth control methods (e.g. condoms)

         11. current daily use of anti-craving medications, mood stabilizers, benzodiazepines, or
             anti-psychotics

         12. 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

         13. a history of alcohol withdrawal-induced seizures or delirium tremens (hallucinations,
             disorientation) requiring hospital admission during the last ten years

         14. a history of moderate or severe traumatic brain injury (TBI; loss of consciousness >30
             minutes69)

         15. left-handedness

         16. any contraindications for MRI