Clinical trial NCT05107765: Effects of Pioglitazone on Stress Reactivity and Alcohol Craving
Official title: Effects of Pioglitazone on Stress Reactivity and Alcohol Craving
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Alcohol Use Disorder
Keywords: alcohol
Pioglitazone
Stress
Anxiety
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of pioglitazone on stress-induced relapse risk in a laboratory model and to examine the effects of pioglitazone on drinking, stress/anxiety, and alcohol craving in the natural environment


Eligibility criteria: Inclusion Criteria:

* treatment-seeking individuals diagnosed with Alcohol Use Disorder Diagnostic (AUD) and Statistical Manual of Mental Disorders, 5th Edition (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)
* exhibit baseline measures of either 1) 8-23 on HAM-A indicative of mild to moderate anxiety, 2) 14-26 on PSS Score indicative of moderate stress, or 3) ≥2 on Drinking Motives Questionnaire (DMQ-R) questions related to drinking indicating that individuals drink at least "some of the time" to cope
* exhibit increased stress reactivity (increased physiological response and/or self-report) at the baseline stress reactivity assessment
* females will need to agree to use of barrier methods of contraception due to pioglitazone's effects on plasma concentrations of oral contraceptives

Exclusion Criteria:

* Exhibit severe scores on the HAM-A, PSS, or PTSD checklist (PCL-5) - may be enrolled at the discretion of the admitting physician (Dr. Weaver)
* physical dependence on alcohol (CIWAA \> 10)
* greater than mild substance use disorder on drugs other than alcohol, nicotine, and marijuana
* contraindications for taking pioglitazone
* medical conditions (e.g., congestive heart failure, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer)
* contraindicating pioglitazone pharmacotherapy or taking contraindicated medications (e.g., CYP2C8 inhibitors or inducers, antihyperglycemic 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

Primary outcomes:
measure: Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)
timeFrame: baseline,week 8
measure: Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)
timeFrame: baseline,week 8
measure: Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT)
timeFrame: baseline,week 8
measure: Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)
timeFrame: baseline,week 8
measure: Change in alcohol craving
timeFrame: baseline,week 8
Secondary outcomes:
measure: change in drinking habit as assessed by the number of drinks per day
timeFrame: baseline to week 8
measure: change in drinking habit as assessed by the number of heavy drinking days
timeFrame: baseline to week 8
measure: Stress as assessed by the Perceived Stress Scale(PSS)
timeFrame: Baseline, week 1,week 2,week3,week 4,week 5,week 6, week 7,week 8
measure: Anxiety as assessed by the Hamilton Anxiety Rating Scale(HAM-A)
timeFrame: Baseline, week 1,week 2,week3,week 4,week 5,week 6, week 7,week 8
measure: Change in alcohol craving as assessed by the Pennsylvania Alcohol Craving Scale(PACS)
timeFrame: baseline,week 8
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center of Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jin H Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References: