Pioglitazone for the Treatment of Alcohol Use Disorder

NCT03864146 | Completed Results DMC

• 2 other identifiers: NURA-015-18SCX-001837-01
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use Disorder; Alcohol dependence; Craving

Outcome Measures

Primary Outcomes (1)

• Heavy Drinking Days Per Week Change

  The primary outcome is change in heavy drinking days per week as measured by the Timeline Follow-back. A heavy drinking day is defined as : \>4 standard drinks in a day for men and \>3 standard drinks in a day for women

  Change between baseline and 14 weeks

Secondary Outcomes (4)

• Number of Subjects With no Heavy Drinking for the Last 8 Weeks of the Study

  heavy drinking between week 7 and 14

• Number of Drinks Per Week

  Change in mean drinks per week from baseline to week 14

• Alcohol Craving

  Change in mean obsessive compulsive drinking scale score from baseline to week 14

• Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS) Positivity

  Change between baseline and 14 weeks

Study Arms (2)

Pioglitazone

EXPERIMENTAL

Pioglitazone titrated to 45mg by mouth each day

Behavioral: Brief Behavioral Compliance Enhancement Treatment

Placebo

PLACEBO COMPARATOR

placebo, identical 45mg pill

Behavioral: Brief Behavioral Compliance Enhancement Treatment

Interventions

Brief Behavioral Compliance Enhancement Treatment BEHAVIORAL

This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.

Also known as: BBCET

Pioglitazone; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Eric Dieperink, MD
• Organization: Minneapolis VAHCS

eric.dieperink@va.gov

612-467-4010

Study Officials

• Eric W. Dieperink, MD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled parallel group study design

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 6, 2019
• Study Start: July 17, 2019
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)