Albuquerque, New Mexico 87106

  • Alcohol Use Disorder

Purpose:

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.


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


Study is Available At:


Original ID:

20-018


NCT ID:

NCT03539432


Secondary ID:


Study Acronym:


Brief Title:

Exploration of Gemfibrozil as a Treatment for AUD


Official Title:

Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Mind Research Network


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:

Funds for the study expired


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

3


Enrollment Type:

Actual


Study Dates

Start Date:May 16, 2018
Completion Date:December 30, 2018
Completion Type:Actual
Primary Completion Date:December 30, 2018
Primary Completion Type:Actual
Verification Date:March 2019
Last Changed Date:March 5, 2019
First Received Date:May 16, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percent days abstinent
Time Frame:6 weeks post baseline
Safety Issues:False
Description:Percentage of days of abstinence from alcohol
Outcome Type:Primary Outcome
Measure:Percent days abstinent
Time Frame:4 weeks post baseline
Safety Issues:False
Description:Percentage of days of abstinence from alcohol
Outcome Type:Primary Outcome
Measure:Percent days abstinent
Time Frame:2 weeks post baseline
Safety Issues:False
Description:Percentage of days of abstinence from alcohol
Outcome Type:Primary Outcome
Measure:Percent days abstinent
Time Frame:Baseline
Safety Issues:False
Description:Percentage of days of abstinence from alcohol
Outcome Type:Primary Outcome
Measure:Drinks per drinking day
Time Frame:6 weeks post baseline
Safety Issues:False
Description:Average number of standard drinks consumed on drinking days
Outcome Type:Primary Outcome
Measure:Drinks per drinking day
Time Frame:4 weeks post baseline
Safety Issues:False
Description:Average number of standard drinks consumed on drinking days
Outcome Type:Primary Outcome
Measure:Drinks per drinking day
Time Frame:2 weeks post baseline
Safety Issues:False
Description:Average number of standard drinks consumed on drinking days
Outcome Type:Primary Outcome
Measure:Drinks per drinking day
Time Frame:Baseline
Safety Issues:False
Description:Average number of standard drinks consumed on drinking days

Study Interventions

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

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Microcrystalline cellulose powder packaged in capsules identical to the experimental condition
Study Arm Type:Experimental
Arm Name:Gemfibrozil
Description:Gemfibrozil 600 mg by mouth twice daily

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The Mind Research Network

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 04, 2021

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