Trial Outcomes & Findings for Exploration of Gemfibrozil as a Treatment for AUD (NCT NCT03539432)

NCT ID: NCT03539432

Last Updated: 2021-10-29

Results Overview

Average number of standard drinks consumed on drinking days

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-10-29

Participant Flow

Participant milestones

Measure	Gemfibrozil Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Placebo 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
Overall Study STARTED	2	1
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Gemfibrozil Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Placebo 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
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Exploration of Gemfibrozil as a Treatment for AUD

Baseline characteristics by cohort

Measure	Gemfibrozil n=2 Participants Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Placebo n=1 Participants 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 n=3 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	2 participants n=93 Participants	1 participants n=4 Participants	3 participants n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline

Average number of standard drinks consumed on drinking days

Outcome measures

Measure	Gemfibrozil n=2 Participants Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Placebo n=1 Participants 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
Mean Standard Drinks Per Drinking Day	6.17 Drinks per drinking day Interval 5.57 to 6.76	8.59 Drinks per drinking day Interval 8.59 to 8.59

PRIMARY outcome

Timeframe: 2 weeks post baseline

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

Average number of standard drinks consumed on drinking days

Outcome measures

Measure	Gemfibrozil n=2 Participants Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Placebo 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
Mean Standard Drinks Per Drinking Day	4.12 Drinks per drinking day Interval 3.58 to 4.667	—

PRIMARY outcome

Timeframe: 4 weeks post baseline

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

Average number of standard drinks consumed on drinking days

Outcome measures

Measure	Gemfibrozil n=2 Participants Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Placebo 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
Mean Standard Drinks Per Drinking Day	2.18 Drinks per drinking day Interval 2.0 to 2.35	—

PRIMARY outcome

Timeframe: Baseline

Percentage of days of abstinence from alcohol

Outcome measures

Measure	Gemfibrozil n=2 Participants Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Placebo n=1 Participants 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
Percent Days Abstinent	31 Percentage of abstinent days Interval 16.7 to 44.4	32.2 Percentage of abstinent days Interval 32.2 to 32.2

PRIMARY outcome

Timeframe: 2 weeks post baseline

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

Percentage of days of abstinence from alcohol

Outcome measures

Measure	Gemfibrozil n=2 Participants Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Placebo 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
Percent Days Abstinent	45.5 Percentage of abstinent days Interval 0.0 to 90.9	—

PRIMARY outcome

Timeframe: 4 weeks post baseline

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

Percentage of days of abstinence from alcohol

Outcome measures

Measure	Gemfibrozil n=2 Participants Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Placebo 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
Percent Days Abstinent	45 Percentage of abstinent days Interval 0.0 to 90.0	—

Adverse Events

Gemfibrozil

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gemfibrozil n=2 participants at risk Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day	Placebo n=1 participants at risk 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
Gastrointestinal disorders Abdominal pain	50.0% 1/2 • Number of events 1 • 4 weeks	0.00% 0/1 • 4 weeks
Nervous system disorders Fatigue	50.0% 1/2 • Number of events 1 • 4 weeks	0.00% 0/1 • 4 weeks
Skin and subcutaneous tissue disorders Bruising	50.0% 1/2 • Number of events 1 • 4 weeks	0.00% 0/1 • 4 weeks

Additional Information

Dr. Eric Claus

The Mind Research Network

Phone: 5055151556

Email: eclaus@mrn.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place