N/A
N=185
Pioglitazone for the Treatment of Alcohol Use Disorder
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03864146 ↗Enrolled (actual)
185
Serious AEs
5.9%
Results posted
Jun 2025
Primary outcome: Primary: Heavy Drinking Days Per Week Change — -1.76; -2.3 Mean heavy drinking days per week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief Behavioral Compliance Enhancement Treatment (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heavy Drinking Days Per Week Change |
-1.76; -2.3 | — |
| SECONDARY Number of Subjects With no Heavy Drinking for the Last 8 Weeks of the Study |
51; 49 | — |
| SECONDARY Number of Drinks Per Week |
-20.15; -21.20 | — |
| SECONDARY Alcohol Craving |
-5.30; -4.0 | — |
| SECONDARY Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS) Positivity |
0.00; -0.03 | — |
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 approved for diabetes, has been shown in pre-clinical studies to reduce alcohol. The proposed study will test the efficacy of pioglitazone to reduce alcohol use in a double-blind placebo controlled trial. Investigators plan to compare pioglitazone to placebo in 200 Veterans who have an AUD and who are currently drinking alcohol at two Veterans Affairs Health Care Centers. The primary hypothesis is that Veterans with an AUD who are currently drinking alcohol will have a greater reduction in alcohol use following treatment with pioglitazone compared to those treated with placebo.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03864146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.