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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03860753
• Other study ID #: HSC-MS-18-0922 (pilot)
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 1, 2019
• Est. completion date: August 23, 2019

Study information

• Verified date: October 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 23, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

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
Pill capsules will look same as that of active drug.

Locations

Country	Name	City	State
United States	The University of Texas Health Science at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)	The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and heart rate will be measured before and after CPT. The heart rate change for each time point is calculated as heart rate after CPT minus the heart rate before CPT. This outcome measure reports the heart rate change at week 4 minus the heart rate change at baseline.	baseline, week 4
Primary	Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)	The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and blood pressure will be measured before and after CPT. The blood pressure change for each time point is calculated as blood pressure after CPT minus the blood pressure before CPT. This outcome measure reports the blood pressure change at week 4 minus the blood pressure change at baseline.	baseline, week 4
Primary	Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)	The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and blood pressure will be measured before and after CPT. The blood pressure change for each time point is calculated as blood pressure after CPT minus the blood pressure before CPT. This outcome measure reports the blood pressure change at week 4 minus the blood pressure change at baseline.	baseline, week 4
Primary	Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)	The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and salivary cortisol level will be measured before and after CPT. The salivary cortisol level change for each time point is calculated as salivary cortisol level after CPT minus the salivary cortisol level before CPT. This outcome measure reports the salivary cortisol level change at week 4 minus the salivary cortisol level change at baseline.	baseline, week 4
Primary	Change in Stress-reactivity as Assessed by Self-report on a Visual Analogue Scale (VAS)	The visual analogue scale (VAS) ranges from 0-10, with a higher score indicating higher stress.	baseline, week 4
Secondary	Change in Alcohol Use as Indicated by Self Report Using the Alcohol Timeline Followback (TLFB)	The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains an estimate of daily drinking. Participants provide a retrospective estimate of the number of drinks per week for the last seven days.	baseline, week 4
Secondary	Change in Alcohol Craving as Assessed by Self Report Using the The Penn Alcohol Craving Scale (PACS).	The Penn Alcohol Craving Scale (PACS) is a 5-item questionnaire that measures an individual's craving to drink alcohol in the past week. Each item is scored on a scale from 0 to 6, with a total score range of 0 to 30. A higher score indicates greater level of alcohol craving.	baseline, week 4