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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860753
Recruitment Status : Terminated (Halted enrollment due to COVID-19)
First Posted : March 4, 2019
Last Update Posted : September 16, 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


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 [ Time Frame: baseline, week 4 ]
  2. Change in stress-reactivity as assessed by systolic blood pressure [ Time Frame: baseline, week 4 ]
  3. Change in stress-reactivity as assessed by diastolic blood pressure [ Time Frame: baseline, week 4 ]
  4. Change in stress-reactivity as assessed by salivary cortisol level [ Time Frame: baseline, week 4 ]
  5. Change in stress-reactivity as assessed by self-report [ Time Frame: baseline, week 4 ]

Secondary Outcome Measures :
  1. Change in alcohol use as indicated by self report [ Time Frame: baseline, week 4 ]
  2. Change in alcohol craving as assessed by self report [ Time Frame: baseline, week 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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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
Last Update Posted: September 16, 2020
Last Verified: September 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