Alcohol Use Disorder
Conditions
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.
Interventions
DRUGGemfibrozil 600 MG
Gemfibrozil capsules (600 mg) taken twice per day
DRUGPlacebo oral capsule
Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
Sponsors
The Mind Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Standard Drinks Per Drinking Day | Baseline | Average number of standard drinks consumed on drinking days |
| Percent Days Abstinent | Baseline | Percentage of days of abstinence from alcohol |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemfibrozil Gemfibrozil 600 mg by mouth twice daily
Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day | 2 |
| 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 | 1 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Gemfibrozil | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 2 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 1 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Mean Standard Drinks Per Drinking Day
Average number of standard drinks consumed on drinking days
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gemfibrozil | Mean Standard Drinks Per Drinking Day | 6.17 Drinks per drinking day |
| Placebo | Mean Standard Drinks Per Drinking Day | 8.59 Drinks per drinking day |
Primary
Mean Standard Drinks Per Drinking Day
Average number of standard drinks consumed on drinking days
Time frame: 2 weeks post baseline
Population: The one participant in the placebo condition dropped out before taking any medication
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gemfibrozil | Mean Standard Drinks Per Drinking Day | 4.12 Drinks per drinking day |
Primary
Mean Standard Drinks Per Drinking Day
Average number of standard drinks consumed on drinking days
Time frame: 4 weeks post baseline
Population: The one participant in the placebo condition dropped out before taking any medication
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gemfibrozil | Mean Standard Drinks Per Drinking Day | 2.18 Drinks per drinking day |
Primary
Percent Days Abstinent
Percentage of days of abstinence from alcohol
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gemfibrozil | Percent Days Abstinent | 31 Percentage of abstinent days |
| Placebo | Percent Days Abstinent | 32.2 Percentage of abstinent days |
Primary
Percent Days Abstinent
Percentage of days of abstinence from alcohol
Time frame: 2 weeks post baseline
Population: The one participant in the placebo condition dropped out before taking any medication
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gemfibrozil | Percent Days Abstinent | 45.5 Percentage of abstinent days |
Primary
Percent Days Abstinent
Percentage of days of abstinence from alcohol
Time frame: 4 weeks post baseline
Population: The one participant in the placebo condition dropped out before taking any medication
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gemfibrozil | Percent Days Abstinent | 45 Percentage of abstinent days |