Exploration of Gemfibrozil as a Treatment for AUD

NCT03539432 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-018
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Gemfibrozil

EXPERIMENTAL

Gemfibrozil 600 mg by mouth twice daily

Drug: Gemfibrozil 600 MG

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose powder packaged in capsules identical to the experimental condition

Drug: Placebo oral capsule

Interventions

Gemfibrozil 600 MG DRUG

Gemfibrozil capsules (600 mg) taken twice per day

Gemfibrozil

Placebo oral capsule DRUG

Microcrystalline cellulose powder packaged in capsules identical to the experimental medication

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Mind Research Network: lead

Study Sites (1)

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Gemfibrozil

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids

Results Point of Contact

• Title: Dr. Eric Claus
• Organization: The Mind Research Network

eclaus@mrn.org

5055151556

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: May 16, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: October 29, 2021
• Results First Posted: October 18, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)