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Thiazolidinedione

Pioglitazone for Alcoholism

Phase 1 & 2
Recruiting
Led By Jin H Yoon, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Past month excessive alcohol use (>7 drinks/week for women, >14 drinks/week for men, >3 drinks/occasion for women, >4 drinks/occasion for men)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1,week 2,week3,week 4,week 5,week 6, week 7,week 8
Awards & highlights

Study Summary

This trial will examine if pioglitazone can help reduce stress-induced relapse risk and help with symptoms of drinking, stress/anxiety, and alcohol craving.

Who is the study for?
This trial is for English-speaking adults seeking treatment for Alcohol Use Disorder who drink heavily and show signs of stress or mild to moderate anxiety. They must not have severe mental health scores, physical dependence on alcohol, significant other drug use (except nicotine/marijuana), certain medical conditions like heart failure or liver disease, or be pregnant/nursing.Check my eligibility
What is being tested?
The study tests Pioglitazone's effect on preventing relapse due to stress in people with Alcohol Use Disorder. It compares the effects of Pioglitazone against a placebo in reducing drinking behavior, stress/anxiety levels, and alcohol craving both in a lab setting and daily life.See study design
What are the potential side effects?
Pioglitazone may cause side effects such as fluid retention leading to swelling and weight gain, potential increase in risk of bladder cancer, heart problems especially if there is pre-existing heart disease, liver issues, anemia and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not drink more than the recommended weekly or per occasion limits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1,week 2,week3,week 4,week 5,week 6, week 7,week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1,week 2,week3,week 4,week 5,week 6, week 7,week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)
Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT)
Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)
+2 more
Secondary outcome measures
Anxiety as assessed by the Hamilton Anxiety Rating Scale(HAM-A)
Change in alcohol craving as assessed by the Pennsylvania Alcohol Craving Scale(PACS)
Stress as assessed by the Perceived Stress Scale(PSS)
+2 more

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01612858
19%
diarrhea
13%
Elevated lactic acid
13%
nausea
13%
Elevated serum creatinine
6%
Bloating
6%
Head trauma accompanied by syncope
6%
vomiting
6%
Baker's cyst
6%
tooth pain
6%
Right upper quadrant abdominal pain
6%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metformin
Pioglitazone

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PioglitazoneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pioglitazone
2005
Completed Phase 4
~27720

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
910 Previous Clinical Trials
323,512 Total Patients Enrolled
7 Trials studying Alcoholism
7,854 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
810 Previous Clinical Trials
1,158,192 Total Patients Enrolled
428 Trials studying Alcoholism
778,322 Patients Enrolled for Alcoholism
Jin H Yoon, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Alcoholism
4 Patients Enrolled for Alcoholism

Frequently Asked Questions

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

Could you inform me of any additional research involving Pioglitazone?

"Currently, 31 clinical trials focusing on Pioglitazone are currently active and 4 of these studies have proceeded to Phase 3. Although Lausanne in Vaud is the primary location for such research, a total of 69 medical centres are running similar investigations."

Answered by AI

What is the aggregate figure of participants involved in this clinical experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical study is presently seeking participants. The trial was initially shared on May 12th 2022 and last updated August 29th 2022. 60 individuals are needed from one location."

Answered by AI

In what medical scenarios is Pioglitazone commonly prescribed?

"Pioglitazone is a reliable choice for managing diabetes, diabetic neuralgia, and diet."

Answered by AI

Does this research project still have openings for participants?

"Affirmative. The clinical trial's presence on clinicaltrials.gov verifies that recruiting efforts are ongoing, beginning with its initial post date of May 12th 2022 and most recently updated on August 29th 2022. An estimated 60 individuals will be invited to join this study across one medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center of Houston
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Drinking is a problem with health now. I have been drinking off and on since 17 yeas of age. I now find that I drink everyday with no breaks. I have a full time job and a great deal of responsibility and I’m under stress so I drink. I’m beginning to see the impact this is having on my life. I would like to seek better ways to get through the stress without drinking. There has to be others out there like me that are searching as well and I would like to help me and others who are walking in my same shoes.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Effects of Pioglitazone on Stress Reactivity and Alcohol Craving
Jin Ho Yoon 2022. "Effects of Pioglitazone on Stress Reactivity and Alcohol Craving". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05107765.
All > Alcoholism
~5 spots leftby Aug 2024
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