Status:
TERMINATED
Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-40 years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03860753
Start Date
March 1 2019
End Date
August 23 2019
Last Update
October 26 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Texas Health Science at Houston
Houston, Texas, United States, 77030