Exploration of Gemfibrozil as a Treatment for AUD

Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder

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.

Study Overview

• Status: Terminated
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: Gemfibrozil 600 MG; Drug: Placebo oral capsule

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • The Mind Research Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gemfibrozil; Gemfibrozil 600 mg by mouth twice daily	Drug: Gemfibrozil 600 MG; Gemfibrozil capsules (600 mg) taken twice per day
PLACEBO_COMPARATOR: Placebo; Microcrystalline cellulose powder packaged in capsules identical to the experimental condition	Drug: Placebo oral capsule; Microcrystalline cellulose powder packaged in capsules identical to the experimental medication

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Mind Research Network

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2018
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (ACTUAL): May 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP2C8 Inhibitors; Gemfibrozil
• Other Study ID Numbers: 20-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No