Exploration of Gemfibrozil as a Treatment for AUD

• Sponsor: The Mind Research Network (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03539432
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Drug: Gemfibrozil 600 MG; Drug: Placebo oral capsule	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder
• Actual Study Start Date: May 16, 2018
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gemfibrozil Gemfibrozil 600 mg by mouth twice daily	Drug: Gemfibrozil 600 MG; Gemfibrozil capsules (600 mg) taken twice per day
Placebo Comparator: Placebo Microcrystalline cellulose powder packaged in capsules identical to the experimental condition	Drug: Placebo oral capsule; Microcrystalline cellulose powder packaged in capsules identical to the experimental medication

Outcome Measures

Primary Outcome Measures

1. Mean Standard Drinks Per Drinking Day [Baseline]

   Average number of standard drinks consumed on drinking days

2. Mean Standard Drinks Per Drinking Day [2 weeks post baseline]

   Average number of standard drinks consumed on drinking days

3. Mean Standard Drinks Per Drinking Day [4 weeks post baseline]

   Average number of standard drinks consumed on drinking days

4. Percent Days Abstinent [Baseline]

   Percentage of days of abstinence from alcohol

5. Percent Days Abstinent [2 weeks post baseline]

   Percentage of days of abstinence from alcohol

6. Percent Days Abstinent [4 weeks post baseline]

   Percentage of days of abstinence from alcohol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Mind Research Network	Albuquerque	New Mexico	United States	87106

Sponsors and Collaborators

• The Mind Research Network

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 27, 2018
• Informed Consent Form - Jun 29, 2018

More Information

Publications

None provided.

• Responsible Party: The Mind Research Network
• ClinicalTrials.gov Identifier: NCT03539432
• Other Study ID Numbers: 20-018
• First Posted: May 29, 2018
• Last Update Posted: Oct 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcoholism; Alcohol Drinking; Gemfibrozil

Study Results

Participant Flow

Arm/Group Title	Gemfibrozil	Placebo
Arm/Group Description	Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
Period Title: Overall Study
STARTED	2	1
COMPLETED	2	0
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Gemfibrozil	Placebo	Total
Arm/Group Description	Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication	Total of all reporting groups
Overall Participants	2	1	3
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	1 100%	3 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 50%	0 0%	1 33.3%
Male	1 50%	1 100%	2 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 50%	0 0%	1 33.3%
Not Hispanic or Latino	1 50%	1 100%	2 66.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%	1 100%	3 100%

Outcome Measures

1. Primary Outcome

Title	Mean Standard Drinks Per Drinking Day
Description	Average number of standard drinks consumed on drinking days
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gemfibrozil	Placebo
Arm/Group Description	Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
Measure Participants	2	1
Mean (Full Range) [Drinks per drinking day]	6.17	8.59

2. Primary Outcome

Title	Mean Standard Drinks Per Drinking Day
Description	Average number of standard drinks consumed on drinking days
Time Frame	2 weeks post baseline

Outcome Measure Data

Analysis Population Description

The one participant in the placebo condition dropped out before taking any medication

Arm/Group Title	Gemfibrozil	Placebo
Arm/Group Description	Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
Measure Participants	2	0
Mean (Full Range) [Drinks per drinking day]	4.12

3. Primary Outcome

Title	Mean Standard Drinks Per Drinking Day
Description	Average number of standard drinks consumed on drinking days
Time Frame	4 weeks post baseline

Outcome Measure Data

Analysis Population Description

The one participant in the placebo condition dropped out before taking any medication

Arm/Group Title	Gemfibrozil	Placebo
Arm/Group Description	Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
Measure Participants	2	0
Mean (Full Range) [Drinks per drinking day]	2.18

4. Primary Outcome

Title	Percent Days Abstinent
Description	Percentage of days of abstinence from alcohol
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gemfibrozil	Placebo
Arm/Group Description	Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
Measure Participants	2	1
Mean (Full Range) [Percentage of abstinent days]	31	32.2

5. Primary Outcome

Title	Percent Days Abstinent
Description	Percentage of days of abstinence from alcohol
Time Frame	2 weeks post baseline

Outcome Measure Data

Analysis Population Description

The one participant in the placebo condition dropped out before taking any medication

Arm/Group Title	Gemfibrozil	Placebo
Arm/Group Description	Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
Measure Participants	2	0
Mean (Full Range) [Percentage of abstinent days]	45.5

6. Primary Outcome

Title	Percent Days Abstinent
Description	Percentage of days of abstinence from alcohol
Time Frame	4 weeks post baseline

Outcome Measure Data

Analysis Population Description

The one participant in the placebo condition dropped out before taking any medication

Arm/Group Title	Gemfibrozil	Placebo
Arm/Group Description	Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
Measure Participants	2	0
Mean (Full Range) [Percentage of abstinent days]	45

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Gemfibrozil		Placebo
Arm/Group Description	Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day		Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
All Cause Mortality
	Gemfibrozil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Serious Adverse Events
	Gemfibrozil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Gemfibrozil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		0/1 (0%)
Gastrointestinal disorders
Abdominal pain	1/2 (50%)	1	0/1 (0%)	0
Nervous system disorders
Fatigue	1/2 (50%)	1	0/1 (0%)	0
Skin and subcutaneous tissue disorders
Bruising	1/2 (50%)	1	0/1 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.