Effects of Pioglitazone on Stress Reactivity and Alcohol Craving
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Alcohol Use Disorder
In brief
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
Key facts
- Study ID
- NCT05107765
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 67
- Starts
- 2022-05-12
- Expected to finish
- 2024-08-16
- Last updated by the study team
- 2025-08-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The University of Texas Health Science Center of Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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