Exploration of Gemfibrozil as a Treatment for AUD
Status: | Terminated |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 3/9/2019 |
Start Date: | May 16, 2018 |
End Date: | December 30, 2018 |
Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder
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.
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.
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
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