Status:
COMPLETED
Pioglitazone for the Treatment of Alcohol Use Disorder
Lead Sponsor:
VA Office of Research and Development
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Alcohol Use Disorder (AUD) is common among Veterans but medication treatment is used infrequently and the impact of these treatments are small to moderate at best. Pioglitazone, a medication FDA appro...
Detailed Description
Background: Alcohol use disorder (AUD) and heavy drinking are common among Veterans with 42.2% of Veterans having a life-time history of AUD and 14.8% screening positive for past-year probable AUD. Al...
Eligibility Criteria
Inclusion
- DSM-5 diagnosis of at least moderate alcohol use disorder using the SCID
- A mean of six heavy drinking days per month for the 3-months prior to baseline.
- Drinking at least 14 drinks for men or 7 drinks for women, or more per week for the 4 weeks preceding the screening visit.
- Willingness to provide contact information to confirm study follow-up appointments
- Ability to perform informed consent
- Female subjects: a negative pregnancy test
- Serum ALT \< 3 times reference range
- Stable psychiatric medication doses the month prior to baseline visit (antidepressant, antipsychotic, subjects may have changes in trazodone for sleep)
Exclusion
- Current DSM-5 diagnosis of moderate to severe psychoactive substance use disorder (i.e. cocaine, opiates, methamphetamine) other than cannabis or nicotine
- Medical conditions contraindicating pioglitazone pharmacotherapy (e.g., congestive heart failure, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer)
- Taking medications known to have significant drug interactions with the study medication (CYP2C8 inhibitors or inducers, antihyperglycemic medications)
- Cognitive or physical impairment that precludes study participation
- Currently and seriously suicidal (i.e., plan and intent)
- Currently being treated for AUD with a medication (naltrexone, naltrexone injectable, acamprosate, topiramate, disulfiram and gabapentin)
- Impending incarceration
- Pregnant or planning to become pregnant during the course of the trial or nursing for female patients
- Unwillingness to sign a written informed consent form
- Unwillingness to use a barrier method of birth control during the study for female patients
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2024
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03864146
Start Date
July 17 2019
End Date
March 29 2024
Last Update
June 13 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
2
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309