Clinical trial NCT03860753: Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)
Official title: Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)
Study type: INTERVENTIONAL
Overall status: TERMINATED
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
First posted: 2019-03-04
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and anxiety.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)
timeFrame: baseline, week 4
measure: Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)
timeFrame: baseline, week 4
measure: Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)
timeFrame: baseline, week 4
measure: Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)
timeFrame: baseline, week 4
measure: Change in Stress-reactivity as Assessed by Self-report on a Visual Analogue Scale (VAS)
timeFrame: baseline, week 4
Secondary outcomes:
measure: Change in Alcohol Use as Indicated by Self Report Using the Alcohol Timeline Followback (TLFB)
timeFrame: baseline, week 4
measure: Change in Alcohol Craving as Assessed by Self Report Using the The Penn Alcohol Craving Scale (PACS).
timeFrame: baseline, week 4
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jin H Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References: