Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)

• Status: Terminated
• Trial end date: 2019-08-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effect of pioglitazone on stress- and alcohol-related measures in treatment-seeking individuals with alcohol use disorder (AUD) and elevated levels of stress and anxiety.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Ethanol; Pioglitazone

Criteria

Inclusion Criteria:

• treatment-seeking individuals diagnosed with AUD diagnostic statistical manual 5 (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)14

• baseline Hamilton Anxiety Rating Scale (HAM-A) or Perceived Stress Scale (PSS) core indicative of mild to moderate anxiety (score 8 to 23) or moderate stress (score 14 to 26), respectively

• increase in alcohol craving following the baseline stress reactivity assessment.

Exclusion Criteria:

• Individuals will be excluded for exhibiting severe scores on the HAM-A, PSS, or post-traumatic (PTSD) checklist (PCL-5) at the discretion of the admitting physician

• physical dependence on alcohol Alcohol Use Disorders Inventory (AUDIT) score indicative of severe alcohol dependence (≥13 for women, ≥15 for men)

• greater than mild substance use disorder on drugs other than alcohol, nicotine, and marijuana

• contraindications for taking pioglitazone; medical conditions contraindicating pioglitazone pharmacotherapy or taking contraindicated 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.