Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Alcohol Use Disorder
In brief
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.
Key facts
- Study ID
- NCT03860753
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 4
- Starts
- 2019-03-01
- Expected to finish
- 2019-08-23
- Last updated by the study team
- 2020-10-26
Who can join
Age: 21 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The University of Texas Health Science at Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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