Exploration of Gemfibrozil as a Treatment for AUD

Phase 2

Terminated

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Gemfibrozil 600 MG; Drug: Placebo oral capsule

• Registration Number: NCT03539432
• Lead Sponsor: The Mind Research Network

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-16
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-29
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Results First Submitted: 2021-08-31
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-21
• Results First Posted: 2021-10-18
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemfibrozil	Gemfibrozil 600 MG	Gemfibrozil 600 mg by mouth twice daily
Placebo	Placebo oral capsule	Microcrystalline cellulose powder packaged in capsules identical to the experimental condition

Primary Outcome Measures

Name	Time	Method
Mean Standard Drinks Per Drinking Day	4 weeks post baseline	Average number of standard drinks consumed on drinking days
Percent Days Abstinent	4 weeks post baseline	Percentage of days of abstinence from alcohol

Trial Locations

Locations (1)

The Mind Research Network; 🇺🇸 Albuquerque, New Mexico, United States