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

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ClinicalTrials.gov Identifier: NCT03860753
Recruitment Status : Terminated (Halted enrollment due to COVID-19)
First Posted : March 4, 2019
Results First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Jin Ho Yoon, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Pioglitazone Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : August 23, 2019
Actual Study Completion Date : August 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Pioglitazone 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 Comparator: Placebo Drug: Placebo
Pill capsules will look same as that of active drug.




Primary Outcome Measures :
  1. Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) [ Time Frame: baseline, week 4 ]
    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.

  2. Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT) [ Time Frame: baseline, week 4 ]
    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.

  3. Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT) [ Time Frame: baseline, week 4 ]
    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.

  4. Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT) [ Time Frame: baseline, week 4 ]
    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.

  5. Change in Stress-reactivity as Assessed by Self-report on a Visual Analogue Scale (VAS) [ Time Frame: baseline, week 4 ]
    The visual analogue scale (VAS) ranges from 0-10, with a higher score indicating higher stress.


Secondary Outcome Measures :
  1. Change in Alcohol Use as Indicated by Self Report Using the Alcohol Timeline Followback (TLFB) [ Time Frame: baseline, week 4 ]
    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.

  2. Change in Alcohol Craving as Assessed by Self Report Using the The Penn Alcohol Craving Scale (PACS). [ Time Frame: baseline, week 4 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860753


Locations
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United States, Texas
The University of Texas Health Science at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Jin H Yoon, PhD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Jin Ho Yoon, The University of Texas Health Science Center, Houston:
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Responsible Party: Jin Ho Yoon, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03860753    
Other Study ID Numbers: HSC-MS-18-0922 (pilot)
First Posted: March 4, 2019    Key Record Dates
Results First Posted: October 26, 2020
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jin Ho Yoon, The University of Texas Health Science Center, Houston:
Alcohol
Pioglitazone
Stress
Anxiety
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs