Alcohol Use DisorderPhase 1/2NCT05107765
Effects of Pioglitazone on Stress Reactivity and Alcohol Craving
A Phase 1/2 study testing Pioglitazone in people with Alcohol Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 16 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center of Houston
Houston, Texas, 77030
About this study
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
- Conditions
- Alcohol Use Disorder
- Being tested
- Pioglitazone, Placebo
- Keywords
- alcohol, Pioglitazone, Stress, Anxiety
- Medical subject headings
- Alcoholism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
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.
PlaceboDrug
Pill capsules will look same as that of active drug.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | Not described Receives: Drug: Pioglitazone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Heart rate will be collected before and after CPT. The change in Heart rate will be reported as [(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)].
Measured: Baseline, about 2 minutes after the start of the cold pressor task
Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Heart rate will be collected before and after CPT. The change in Heart rate will be reported as [(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)].
Measured: Week 8, about 2 minutes after the start of the Cold Pressor Task
Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Systolic Blood Pressure will be collected before and after CPT. The change in Systolic Blood Pressure will be reported as [( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)].
Measured: Baseline, about 2 minutes after the start of the Cold Pressor Task
Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Systolic Blood Pressure will be collected before and after CPT. The change in Systolic Blood Pressure will be reported as [( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)].
Measured: Week 8, about 2 minutes after the start of the Cold Pressor Task
Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT)
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Diastolic Blood Pressure will be collected before and after CPT. The change in Diastolic Blood Pressure will be reported as [( Diastolic Blood Pressure post cold pressor task) - (Diastolic Blood Pressure pre cold pressor task)].
Measured: Baseline, about 2 minutes after the start of the Cold Pressor Task
Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT)
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Diastolic Blood Pressure will be collected before and after CPT. The change in Diastolic Blood Pressure will be reported as [( Diastolic Blood Pressure post cold pressor task) - (Diastolic Blood Pressure pre cold pressor task)].
Measured: Week 8, about 2 minutes after the start of the Cold Pressor Task
Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as [(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)].
Measured: baseline, about 32 minutes after the start of the Cold Pressor Task
Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as [(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)].
Measured: week 8, about 32 minutes after the start of the Cold Pressor Task
Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT)
The alcohol craving scale has a total score from 0 to 50, higher score indicating greater alcohol craving. During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. The Alcohol Craving Scale will be administered before and after CPT. The change in alcohol craving will be reported as [(Alcohol craving scale score post cold pressor task) - (Alcohol craving scale score pre cold pressor task)]. -- a negative value indicates a decrease in alcohol craving.
Measured: baseline, about 2 minutes after the start of the CPT
Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT)
The alcohol craving scale has a total score from 0 to 50, higher score indicating greater alcohol craving. During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. The Alcohol Craving Scale will be administered before and after CPT. The change in alcohol craving will be reported as [(Alcohol craving scale score post cold pressor task) - (Alcohol craving scale score pre cold pressor task)]. -- a negative value indicates a decrease in alcohol craving.
Measured: week 8, about 2 minutes after the start of the CPT
Secondary outcomes (22)
Change in Drinking Habit as Assessed by the Number of Drinks Per Day (Timeline Followback Method)
The Timeline Followback (TLFB) method was used to assess alcohol consumption by asking study participants to self-report their number of drinks consumed each day over the past week.
The change in drinking habit is reported as [(number of drinks per day at week 8) - (number of drinks per day at baseline)].-- a negative value indicates a decrease in alcohol consumption over time.
Measured: baseline, week 8
Change in Drinking Habit as Assessed by the Number of Heavy Drinking Days (Timeline Followback Method)
The Timeline Followback (TLFB) method was used to assess alcohol consumption by asking study participants to self-report their number of drinks consumed each day over the past week.
Heavy drinking is defined as 4 drinks or more per day for females and 5 or more drinks per day for males. The change in drinking habit is reported as [(number of heavy drinking days at week 8) - (number of heavy drinking days at baseline)].--A negative value indicates a decrease in the number of heavy drinking days over time.
Measured: baseline, week 8
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety.
Measured: Baseline
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety.
Measured: week 1
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety.
Measured: week 2
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety.
Measured: week 3
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety.
Measured: week 4
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety.
Measured: week 5
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety.
Measured: week 6
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety.
Measured: week 7
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
The Hamilton Anxiety Rating Scale(HAM-A) is a 14 item questionnaire scored from 0 (not present) to 4 (very severe). The 14 items are summed to obtain a total score ranging from 0 to 56, high scores indicating greater anxiety.
Measured: week 8
Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS)
The Pennsylvania Alcohol Craving Scale(PACS) total score ranges from 0 to 30, higher scores indicating more alcohol cravings.
Measured: baseline
Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS)
The Pennsylvania Alcohol Craving Scale(PACS) total score ranges from 0 to 30, higher scores indicating more alcohol cravings.
Measured: Week 8
Stress as Assessed by the Perceived Stress Scale(PSS)
The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress.
Measured: Baseline
Stress as Assessed by the Perceived Stress Scale(PSS)
The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress.
Measured: Week 1
Stress as Assessed by the Perceived Stress Scale(PSS)
The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress.
Measured: Week 2
Stress as Assessed by the Perceived Stress Scale(PSS)
The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress.
Measured: Week 3
Stress as Assessed by the Perceived Stress Scale(PSS)
The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress.
Measured: Week 4
Stress as Assessed by the Perceived Stress Scale(PSS)
The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress.
Measured: Week 5
Stress as Assessed by the Perceived Stress Scale(PSS)
The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress.
Measured: Week 6
Stress as Assessed by the Perceived Stress Scale(PSS)
The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress.
Measured: Week 7
Stress as Assessed by the Perceived Stress Scale(PSS)
The Perceived Stress Scale(PSS) is a 10 item questionnaire scored from 0 (never) to 4 (very often). The 10 items are summed to obtain a total score ranging from 0 to 40, high scores indicating greater stress.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start12 May 2022
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jin Ho Yoon, The University of Texas Health Science Center, Houston
- Investigators
- Jin H Yoon, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107765
- Sponsor's protocol ID
- HSC-MS-18-0922 (main study)
- Other IDs
- 1R21AA027273-01A1
- Status last verified
- Aug 2025
- First submitted
- 25 Oct 2021
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pioglitazone on Stress Reactivity and Alcohol Craving
- ClinicalTrials.gov ID
- NCT05107765
- Acronym / sponsor ID
- HSC-MS-18-0922 (main study)
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol, Pioglitazone, Stress, Anxiety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Posted 27 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: Pioglitazone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PioglitazoneFor 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. | Drug | Pioglitazone |
| PlaceboPill capsules will look same as that of active drug. | Drug | Placebo |
Primary outcome
Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)
Time frame: Baseline, about 2 minutes after the start of the cold pressor task
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Heart rate will be collected before and after CPT. The change in Heart rate will be reported as [(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)].
Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)
Time frame: Week 8, about 2 minutes after the start of the Cold Pressor Task
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Heart rate will be collected before and after CPT. The change in Heart rate will be reported as [(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)].
Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)
Time frame: Baseline, about 2 minutes after the start of the Cold Pressor Task
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Systolic Blood Pressure will be collected before and after CPT. The change in Systolic Blood Pressure will be reported as [( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)].
Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)
Time frame: Week 8, about 2 minutes after the start of the Cold Pressor Task
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Systolic Blood Pressure will be collected before and after CPT. The change in Systolic Blood Pressure will be reported as [( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)].
Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT)
Time frame: Baseline, about 2 minutes after the start of the Cold Pressor Task
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Diastolic Blood Pressure will be collected before and after CPT. The change in Diastolic Blood Pressure will be reported as [( Diastolic Blood Pressure post cold pressor task) - (Diastolic Blood Pressure pre cold pressor task)].
Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT)
Time frame: Week 8, about 2 minutes after the start of the Cold Pressor Task
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Diastolic Blood Pressure will be collected before and after CPT. The change in Diastolic Blood Pressure will be reported as [( Diastolic Blood Pressure post cold pressor task) - (Diastolic Blood Pressure pre cold pressor task)].
Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)
Time frame: baseline, about 32 minutes after the start of the Cold Pressor Task
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as [(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)].
Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)
Time frame: week 8, about 32 minutes after the start of the Cold Pressor Task
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as [(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)].
Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT)
Time frame: baseline, about 2 minutes after the start of the CPT
The alcohol craving scale has a total score from 0 to 50, higher score indicating greater alcohol craving. During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. The Alcohol Craving Scale will be administered before and after CPT. The change in alcohol craving will be reported as [(Alcohol craving scale score post cold pressor task) - (Alcohol craving scale score pre cold pressor task)]. -- a negative value indicates a decrease in alcohol craving.
Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT)
Time frame: week 8, about 2 minutes after the start of the CPT
The alcohol craving scale has a total score from 0 to 50, higher score indicating greater alcohol craving. During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. The Alcohol Craving Scale will be administered before and after CPT. The change in alcohol craving will be reported as [(Alcohol craving scale score post cold pressor task) - (Alcohol craving scale score pre cold pressor task)]. -- a negative value indicates a decrease in alcohol craving.
22 secondary outcomes
Change in Drinking Habit as Assessed by the Number of Drinks Per Day (Timeline Followback Method)
Time frame: baseline, week 8
Change in Drinking Habit as Assessed by the Number of Heavy Drinking Days (Timeline Followback Method)
Time frame: baseline, week 8
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
Time frame: Baseline
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
Time frame: week 1
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
Time frame: week 2
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
Time frame: week 3
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
Time frame: week 4
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
Time frame: week 5
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
Time frame: week 6
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
Time frame: week 7
Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)
Time frame: week 8
Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS)
Time frame: baseline
Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS)
Time frame: Week 8
Stress as Assessed by the Perceived Stress Scale(PSS)
Time frame: Baseline
Stress as Assessed by the Perceived Stress Scale(PSS)
Time frame: Week 1
Stress as Assessed by the Perceived Stress Scale(PSS)
Time frame: Week 2
Stress as Assessed by the Perceived Stress Scale(PSS)
Time frame: Week 3
Stress as Assessed by the Perceived Stress Scale(PSS)
Time frame: Week 4
Stress as Assessed by the Perceived Stress Scale(PSS)
Time frame: Week 5
Stress as Assessed by the Perceived Stress Scale(PSS)
Time frame: Week 6
Stress as Assessed by the Perceived Stress Scale(PSS)
Time frame: Week 7
Stress as Assessed by the Perceived Stress Scale(PSS)
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin H Yoon, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pioglitazone in people with Alcohol Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) (time frame: Baseline, about 2 minutes after the start of the cold pressor task). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.