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Effects of Pioglitazone on Stress Reactivity and Alcohol Craving

Primary Purpose

Alcohol Use Disorder

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pioglitazone

Placebo

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring alcohol, Pioglitazone, Stress, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center of HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pioglitazone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)

Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)

Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT)

Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)

Change in alcohol craving

This self report assessment will be based on the human laboratory stress reactivity assessment and will be measured by the Alcohol craving scale which is a 5 item questionnaire and each item is scored form 0( none)- 10 (extreme) a higher number indicating a higher alcohol craving with a maximum score of 50.

Secondary Outcome Measures

change in drinking habit as assessed by the number of drinks per day

change in drinking habit as assessed by the number of heavy drinking days

Stress as assessed by the Perceived Stress Scale(PSS)

This self report scale is a 10 item questionnaire and is scored form 0(never)-4( very often) for a maximum score of 40

Anxiety as assessed by the Hamilton Anxiety Rating Scale(HAM-A)

This self report scale is a 14 item questionnaire scored form 0(not present) to 4 (very severe) with a maximum score of 56

Change in alcohol craving as assessed by the Pennsylvania Alcohol Craving Scale(PACS)

The PACS is a five-item self-administered instrument for assessing craving. Frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking. The final item asks the responder to provide an average rating of his/her craving over the course of the past week. Each item is scored from 0(none)-10(extreme), a higher number indicating more craving.

Full Information

NCT ID

NCT05107765

First Posted

October 25, 2021

Last Updated

August 29, 2022

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT05107765

Brief Title

Effects of Pioglitazone on Stress Reactivity and Alcohol Craving

Official Title

Effects of Pioglitazone on Stress Reactivity and Alcohol Craving

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 12, 2022 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

alcohol, Pioglitazone, Stress, Anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pioglitazone

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Pioglitazone

Intervention Description

For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by end of week 1, which is within standard titration parameters as per the investigator's brochure.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pill capsules will look same as that of active drug.

Primary Outcome Measure Information:

Title

Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)

Time Frame

baseline,week 8

Title

Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)

Time Frame

baseline,week 8

Title

Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT)

Time Frame

baseline,week 8

Title

Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)

Time Frame

baseline,week 8

Title

Change in alcohol craving

Description

Time Frame

baseline,week 8

Secondary Outcome Measure Information:

Title

change in drinking habit as assessed by the number of drinks per day

Time Frame

baseline to week 8

Title

change in drinking habit as assessed by the number of heavy drinking days

Time Frame

baseline to week 8

Title

Stress as assessed by the Perceived Stress Scale(PSS)

Description

This self report scale is a 10 item questionnaire and is scored form 0(never)-4( very often) for a maximum score of 40

Time Frame

Baseline, week 1,week 2,week3,week 4,week 5,week 6, week 7,week 8

Title

Anxiety as assessed by the Hamilton Anxiety Rating Scale(HAM-A)

Description

This self report scale is a 14 item questionnaire scored form 0(not present) to 4 (very severe) with a maximum score of 56

Time Frame

Baseline, week 1,week 2,week3,week 4,week 5,week 6, week 7,week 8

Title

Change in alcohol craving as assessed by the Pennsylvania Alcohol Craving Scale(PACS)

Description

Time Frame

baseline,week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jin H Yoon, PhD

Phone

713-486-2800

jin.ho.yoon@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica Vincent

Phone

(713) 486-2645

Jessica.N.Vincent@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin H Yoon, PhD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center of Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin H Yoon, PhD

Phone

713-486-2800

jin.ho.yoon@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Jessica Vincent

Phone

(713) 486-2645

Jessica.N.Vincent@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Pioglitazone on Stress Reactivity and Alcohol Craving

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