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Exploration of Gemfibrozil as a Treatment for AUD

NCT ID: NCT03539432

Last Updated: 2021-10-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-16

Study Completion Date

2018-12-30

Brief Summary

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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

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Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gemfibrozil

Gemfibrozil 600 mg by mouth twice daily

Group Type EXPERIMENTAL

Gemfibrozil 600 MG

Intervention Type DRUG

Gemfibrozil capsules (600 mg) taken twice per day

Placebo

Microcrystalline cellulose powder packaged in capsules identical to the experimental condition

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Microcrystalline cellulose powder packaged in capsules identical to the experimental medication

Interventions

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Gemfibrozil 600 MG

Gemfibrozil capsules (600 mg) taken twice per day

Intervention Type DRUG

Placebo oral capsule

Microcrystalline cellulose powder packaged in capsules identical to the experimental medication

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Mind Research Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Mind Research Network

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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20-018

Identifier Type: -

Identifier Source: org_study_id