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

The University of Texas System (UT)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Alcohol Use Disorder

Treatments

Drug: Pioglitazone

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03860753

HSC-MS-18-0922 (pilot)

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

21 to 40 years old

Volunteers

No Healthy Volunteers

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.