Examining how pioglitazone affects stress and alcohol cravings
Effects of Pioglitazone on Stress Reactivity and Alcohol Craving
PHASE1; PHASE2 · The University of Texas Health Science Center, Houston · NCT05107765
This study is testing if the diabetes medication pioglitazone can help people with Alcohol Use Disorder manage stress and reduce their cravings for alcohol.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05107765 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of pioglitazone, a medication typically used for diabetes, on stress-induced relapse risk and alcohol cravings in individuals with Alcohol Use Disorder. Participants will be treated with either pioglitazone or a placebo while their drinking behaviors, stress levels, and anxiety are monitored in both controlled laboratory settings and natural environments. The study aims to understand how this medication may help reduce cravings and improve stress management in those seeking treatment for alcohol use issues.
Who should consider this trial
Good fit: Ideal candidates are treatment-seeking individuals diagnosed with Alcohol Use Disorder who experience mild to moderate anxiety and increased stress reactivity.
Not a fit: Patients with severe anxiety, PTSD, or those not seeking treatment for Alcohol Use Disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to help individuals with Alcohol Use Disorder manage cravings and reduce relapse risk.
How similar studies have performed: While the use of pioglitazone for this purpose is novel, similar studies exploring pharmacological interventions for alcohol cravings have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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 this trial is running
Houston, Texas
- The University of Texas Health Science Center of Houston — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Jin H Yoon, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Jin H Yoon, PhD
- Email: jin.ho.yoon@uth.tmc.edu
- Phone: 713-486-2800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Use Disorder, alcohol, Pioglitazone, Stress, Anxiety