Exploration of Gemfibrozil as a Treatment for AUD
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Alcohol Use Disorder
In brief
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.
Key facts
- Study ID
- NCT03539432
- Run by
- The Mind Research Network
- People needed
- 3
- Starts
- 2018-05-16
- Expected to finish
- 2018-12-30
- Last updated by the study team
- 2021-10-29
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Mind Research Network — Albuquerque, New Mexico, United States
Full record on ClinicalTrials.gov
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