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Thiazolidinedione

Pioglitazone for Alcoholism (PAUSE Trial)

N/A
Recruiting
Led By Eric W. Dieperink, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to perform informed consent
Female subjects: a negative pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weekly through week 8 then week 10, 12 and 14.
Awards & highlights

PAUSE Trial Summary

This trial will test whether pioglitazone, a medication approved for diabetes, can help reduce alcohol use in Veterans. 200 Veterans with an AUD will be given either pioglitazone or a placebo, and the impact of the medication will be measured.

Who is the study for?
This trial is for Veterans with Alcohol Use Disorder (AUD) who are currently drinking heavily. Participants must have a moderate AUD diagnosis, be willing to follow up, and not be on other AUD medications. Women must test negative for pregnancy and agree to use birth control. People with severe mental health disorders, significant medical conditions like heart failure or liver disease, or those at risk of suicide cannot join.Check my eligibility
What is being tested?
The study is testing if Pioglitazone can help reduce alcohol consumption in people with AUD compared to a placebo. It's a double-blind trial involving 200 Veterans at two VA Health Care Centers where neither the participants nor the researchers know who gets the real medicine versus the placebo.See study design
What are the potential side effects?
Pioglitazone may cause side effects such as edema (swelling), weight gain, anemia (low red blood cell count), headache, muscle pain, sore throat and respiratory infections. There might also be risks related to liver function changes.

PAUSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand and can give consent for my treatment.
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I am not pregnant.
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My psychiatric medication doses have been stable for the last month.
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I have been drinking more than the recommended amount weekly for the past month.

PAUSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weekly through week 8 then week 10, 12 and 14.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weekly through week 8 then week 10, 12 and 14. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
heavy drinking days per week change
Secondary outcome measures
Alcohol craving
No heavy drinking for the last 8 weeks of the study
Number of drinks per week
+1 more

PAUSE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PioglitazoneExperimental Treatment1 Intervention
Pioglitazone titrated to 45mg by mouth each day
Group II: PlaceboPlacebo Group1 Intervention
placebo, identical 45mg pill

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,403 Total Patients Enrolled
41 Trials studying Alcoholism
6,275 Patients Enrolled for Alcoholism
Eric W. Dieperink, MDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN
1 Previous Clinical Trials
139 Total Patients Enrolled
1 Trials studying Alcoholism
139 Patients Enrolled for Alcoholism

Media Library

Pioglitazone (Thiazolidinedione) Clinical Trial Eligibility Overview. Trial Name: NCT03864146 — N/A
Alcoholism Research Study Groups: Placebo, Pioglitazone
Alcoholism Clinical Trial 2023: Pioglitazone Highlights & Side Effects. Trial Name: NCT03864146 — N/A
Pioglitazone (Thiazolidinedione) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03864146 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are eligible to participate in this trial?

"Correct. Clinicaltrials.gov displays that this clinical experiment, which was initially published on July 17th 2019, is actively recruiting participants. This trial aims to recruit 200 individuals from 2 separate locations."

Answered by AI

Is recruitment for this trial still open?

"Affirmative. Clinicaltrials.gov shows that this medical trial, which began on July 17th 2019, is still taking in participants. 200 individuals are expected to be recruited between two sites."

Answered by AI

Who else is applying?

What site did they apply to?
VA Long Beach Healthcare System, Long Beach, CA
Minneapolis VA Health Care System, Minneapolis, MN
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Pioglitazone for the Treatment of Alcohol Use Disorder
2019. "Pioglitazone for the Treatment of Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03864146.
All > Alcoholism
~35 spots leftby Apr 2025
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