COMPLETED

Effects of Pioglitazone on Stress Reactivity and Alcohol Craving

Conditions

Alcohol Use Disorder alcohol Pioglitazone Stress Anxiety

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to examine the effects of pioglitazone on stress-induced relapse risk in a laboratory model and to examine the effects of pioglitazone on drinking, stress/anxiety, and alcohol craving in the natural environment

Official Title

Effects of Pioglitazone on Stress Reactivity and Alcohol Craving

Quick Facts

Study Start:2022-05-12

Study Completion:2024-08-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05107765

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* treatment-seeking individuals diagnosed with Alcohol Use Disorder Diagnostic (AUD) and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) * fluent in English * past month excessive alcohol use (\>7 drinks/week for woman, \>14 drinks/week for men, \>3 drinks/occasion for women\>4 drinks/occasion for men) * exhibit baseline measures of either 1) 8-23 on HAM-A indicative of mild to moderate anxiety, 2) 14-26 on PSS Score indicative of moderate stress, or 3) ≥2 on Drinking Motives Questionnaire (DMQ-R) questions related to drinking indicating that individuals drink at least "some of the time" to cope * exhibit increased stress reactivity (increased physiological response and/or self-report) at the baseline stress reactivity assessment * females will need to agree to use of barrier methods of contraception due to pioglitazone's effects on plasma concentrations of oral contraceptives	* Exhibit severe scores on the HAM-A, PSS, or PTSD checklist (PCL-5) - may be enrolled at the discretion of the admitting physician (Dr. Weaver) * physical dependence on alcohol (CIWAA \> 10) * greater than mild substance use disorder on drugs other than alcohol, nicotine, and marijuana * contraindications for taking pioglitazone * medical conditions (e.g., congestive heart failure, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer) * contraindicating pioglitazone pharmacotherapy or taking contraindicated medications (e.g., CYP2C8 inhibitors or inducers, antihyperglycemic medications) * be pregnant, nursing, or planning on becoming pregnant during the course of the study * have any other illness, condition, or use of medications, which in the opinion of the PI and/or admitting physician would preclude safe and/or successful completion of the study

Inclusion Criteria

Exclusion Criteria

* treatment-seeking individuals diagnosed with Alcohol Use Disorder Diagnostic (AUD) and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
* fluent in English
* past month excessive alcohol use (\>7 drinks/week for woman, \>14 drinks/week for men, \>3 drinks/occasion for women\>4 drinks/occasion for men)
* exhibit baseline measures of either 1) 8-23 on HAM-A indicative of mild to moderate anxiety, 2) 14-26 on PSS Score indicative of moderate stress, or 3) ≥2 on Drinking Motives Questionnaire (DMQ-R) questions related to drinking indicating that individuals drink at least "some of the time" to cope
* exhibit increased stress reactivity (increased physiological response and/or self-report) at the baseline stress reactivity assessment
* females will need to agree to use of barrier methods of contraception due to pioglitazone's effects on plasma concentrations of oral contraceptives

* Exhibit severe scores on the HAM-A, PSS, or PTSD checklist (PCL-5) - may be enrolled at the discretion of the admitting physician (Dr. Weaver)
* physical dependence on alcohol (CIWAA \> 10)
* greater than mild substance use disorder on drugs other than alcohol, nicotine, and marijuana
* contraindications for taking pioglitazone
* medical conditions (e.g., congestive heart failure, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer)
* contraindicating pioglitazone pharmacotherapy or taking contraindicated medications (e.g., CYP2C8 inhibitors or inducers, antihyperglycemic medications)
* be pregnant, nursing, or planning on becoming pregnant during the course of the study
* have any other illness, condition, or use of medications, which in the opinion of the PI and/or admitting physician would preclude safe and/or successful completion of the study

Contacts and Locations

Principal Investigator

Jin H Yoon, PhD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center of Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Jin H Yoon, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-12

Study Completion Date2024-08-16

Study Record Updates

Study Start Date2022-05-12

Study Completion Date2024-08-16

Terms related to this study

Keywords Provided by Researchers

alcohol
Pioglitazone
Stress
Anxiety

Additional Relevant MeSH Terms

Alcohol Use Disorder