Exploration of Gemfibrozil as a Treatment for AUD

Alcohol Use Disorder Clinical Trial

Official title:

Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03539432
• Other study ID #: 20-018
• Status: Terminated
• Phase: Phase 2
• Start date: May 16, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: September 2021
• Source: The Mind Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Gemfibrozil 600 MG
Gemfibrozil capsules (600 mg) taken twice per day
• Placebo oral capsule
Microcrystalline cellulose powder packaged in capsules identical to the experimental medication

Locations

Country	Name	City	State
United States	The Mind Research Network	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
The Mind Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Standard Drinks Per Drinking Day	Average number of standard drinks consumed on drinking days	Baseline
Primary	Mean Standard Drinks Per Drinking Day	Average number of standard drinks consumed on drinking days	2 weeks post baseline
Primary	Mean Standard Drinks Per Drinking Day	Average number of standard drinks consumed on drinking days	4 weeks post baseline
Primary	Percent Days Abstinent	Percentage of days of abstinence from alcohol	Baseline
Primary	Percent Days Abstinent	Percentage of days of abstinence from alcohol	2 weeks post baseline
Primary	Percent Days Abstinent	Percentage of days of abstinence from alcohol	4 weeks post baseline