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

Purpose

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.

Condition

  • Alcohol Use Disorder

Eligibility

Eligible Ages
Between 21 Years and 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pioglitazone
  • Drug: Pioglitazone
    For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
Placebo Comparator
Placebo
  • Drug: Placebo
    Pill capsules will look same as that of active drug.

More Details

Status
Terminated
Sponsor
The University of Texas Health Science Center, Houston

Study Contact