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Exploration of Gemfibrozil as a Treatment for AUD

Primary Purpose

Alcohol Use Disorder

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemfibrozil 600 MG
Placebo oral capsule
Sponsored by
The Mind Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Mind Research Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gemfibrozil

Placebo

Arm Description

Gemfibrozil 600 mg by mouth twice daily

Microcrystalline cellulose powder packaged in capsules identical to the experimental condition

Outcomes

Primary Outcome Measures

Mean Standard Drinks Per Drinking Day
Average number of standard drinks consumed on drinking days
Mean Standard Drinks Per Drinking Day
Average number of standard drinks consumed on drinking days
Mean Standard Drinks Per Drinking Day
Average number of standard drinks consumed on drinking days
Percent Days Abstinent
Percentage of days of abstinence from alcohol
Percent Days Abstinent
Percentage of days of abstinence from alcohol
Percent Days Abstinent
Percentage of days of abstinence from alcohol

Secondary Outcome Measures

Full Information

First Posted
May 16, 2018
Last Updated
October 18, 2021
Sponsor
The Mind Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT03539432
Brief Title
Exploration of Gemfibrozil as a Treatment for AUD
Official Title
Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Funds for the study expired
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Mind Research Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemfibrozil
Arm Type
Experimental
Arm Description
Gemfibrozil 600 mg by mouth twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Microcrystalline cellulose powder packaged in capsules identical to the experimental condition
Intervention Type
Drug
Intervention Name(s)
Gemfibrozil 600 MG
Intervention Description
Gemfibrozil capsules (600 mg) taken twice per day
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
Primary Outcome Measure Information:
Title
Mean Standard Drinks Per Drinking Day
Description
Average number of standard drinks consumed on drinking days
Time Frame
Baseline
Title
Mean Standard Drinks Per Drinking Day
Description
Average number of standard drinks consumed on drinking days
Time Frame
2 weeks post baseline
Title
Mean Standard Drinks Per Drinking Day
Description
Average number of standard drinks consumed on drinking days
Time Frame
4 weeks post baseline
Title
Percent Days Abstinent
Description
Percentage of days of abstinence from alcohol
Time Frame
Baseline
Title
Percent Days Abstinent
Description
Percentage of days of abstinence from alcohol
Time Frame
2 weeks post baseline
Title
Percent Days Abstinent
Description
Percentage of days of abstinence from alcohol
Time Frame
4 weeks post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 any contraindications for MRI
Facility Information:
Facility Name
The Mind Research Network
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exploration of Gemfibrozil as a Treatment for AUD

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