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

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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.


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
We found this trial at
1
site
Albuquerque, New Mexico 87131
Phone: 505-272-5028
?
mi
from
Albuquerque, NM
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