Alcohol Use Disorder
Conditions
Keywords
alcohol, Pioglitazone, Stress, Anxiety
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
Interventions
DRUGPioglitazone
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.
DRUGPlacebo
Pill capsules will look same as that of active drug.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT) | 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 Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) | 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 Change in Systolic Blood Pressure During the Cold Pressor Task (CPT) | 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 Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT) | 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 Salivary Cortisol Level Change During the Cold Pressor Task (CPT) | 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 \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Drinking Habit as Assessed by the Number of Drinks Per Day (Timeline Followback Method) | baseline, week 8 | 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. |
| Change in Drinking Habit as Assessed by the Number of Heavy Drinking Days (Timeline Followback Method) | baseline, week 8 | 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. |
| Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | Baseline | 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. |
| Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS) | baseline | The Pennsylvania Alcohol Craving Scale(PACS) total score ranges from 0 to 30, higher scores indicating more alcohol cravings. |
| Stress as Assessed by the Perceived Stress Scale(PSS) | Baseline | 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. |
Countries
United States
Participant flow
Pre-assignment details
Of the 67 participants enrolled, 55 were randomized; 8 were lost to follow-up before randomization, and 4 withdrew before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Pill capsules will look same as that of active drug. | 29 |
| Pioglitazone 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 end of week 1, which is within standard titration parameters as per the investigator's brochure. | 26 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Withdrawal by Subjects due to scheduling issues | 6 | 3 |
| Overall Study | Withdrawn by investigator due to non-compliance | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Pioglitazone |
|---|---|---|---|
| Age, Continuous | 38.03 years STANDARD_DEVIATION 13.63 | 35.93 years STANDARD_DEVIATION 12.36 | 33.58 years STANDARD_DEVIATION 10.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 19 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 36 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 17 Participants | 32 Participants | 15 Participants |
| Region of Enrollment United States | 29 participants | 55 participants | 26 participants |
| Sex: Female, Male Female | 17 Participants | 33 Participants | 16 Participants |
| Sex: Female, Male Male | 12 Participants | 22 Participants | 10 Participants |
| Years of Education | 15.38 years STANDARD_DEVIATION 1.92 | 15.64 years STANDARD_DEVIATION 2.12 | 15.92 years STANDARD_DEVIATION 2.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 26 |
| other Total, other adverse events | 25 / 29 | 22 / 26 |
| serious Total, serious adverse events | 0 / 29 | 0 / 26 |
Outcome results
Primary
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.
Time frame: week 8, about 2 minutes after the start of the CPT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT) | 0.367 score on a scale | Standard Deviation 0.963 |
| Pioglitazone | Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT) | 1.173 score on a scale | Standard Deviation 2.196 |
Primary
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.
Time frame: baseline, about 2 minutes after the start of the CPT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT) | -0.083 score on a scale | Standard Deviation 1.36 |
| Pioglitazone | Change in Alcohol Craving as Assessed by Alcohol Craving Scale Score During the Cold Pressor Task (CPT) | 0.092 score on a scale | Standard Deviation 1.877 |
Primary
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 \[( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)\].
Time frame: Week 8, about 2 minutes after the start of the Cold Pressor Task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT) | 17.778 millimeters of mercury (mmHg) | Standard Deviation 10.963 |
| Pioglitazone | Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT) | 21.091 millimeters of mercury (mmHg) | Standard Deviation 15.165 |
Primary
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 \[( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)\].
Time frame: Baseline, about 2 minutes after the start of the Cold Pressor Task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT) | 19.931 millimeters of mercury (mmHg) | Standard Deviation 12.236 |
| Pioglitazone | Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT) | 20.038 millimeters of mercury (mmHg) | Standard Deviation 13.721 |
Primary
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 \[( Diastolic Blood Pressure post cold pressor task) - (Diastolic Blood Pressure pre cold pressor task)\].
Time frame: Week 8, about 2 minutes after the start of the Cold Pressor Task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT) | 12 millimeters of mercury (mmHg) | Standard Deviation 9.911 |
| Pioglitazone | Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT) | 13.545 millimeters of mercury (mmHg) | Standard Deviation 10.613 |
Primary
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 \[( Diastolic Blood Pressure post cold pressor task) - (Diastolic Blood Pressure pre cold pressor task)\].
Time frame: Baseline, about 2 minutes after the start of the Cold Pressor Task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT) | 12.793 millimeters of mercury (mmHg) | Standard Deviation 8.862 |
| Pioglitazone | Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)Cold Pressor Task (CPT) | 13.192 millimeters of mercury (mmHg) | Standard Deviation 10.257 |
Primary
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 \[(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)\].
Time frame: Week 8, about 2 minutes after the start of the Cold Pressor Task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) | 4.444 beats per minutes (bpm) | Standard Deviation 8.118 |
| Pioglitazone | Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) | 11.182 beats per minutes (bpm) | Standard Deviation 12.945 |
Primary
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 \[(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)\].
Time frame: Baseline, about 2 minutes after the start of the cold pressor task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) | 5.138 beats per minutes (bpm) | Standard Deviation 11.426 |
| Pioglitazone | Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT) | 12.154 beats per minutes (bpm) | Standard Deviation 11.885 |
Primary
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 \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].
Time frame: baseline, about 32 minutes after the start of the Cold Pressor Task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT) | 230.087 picograms per milliliter (pg/mL) | Standard Deviation 1040.858 |
| Pioglitazone | Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT) | 908.96 picograms per milliliter (pg/mL) | Standard Deviation 2046.185 |
Primary
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 \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].
Time frame: week 8, about 32 minutes after the start of the Cold Pressor Task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT) | 427.61 picograms per milliliter (pg/mL) | Standard Deviation 917.927 |
| Pioglitazone | Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT) | 447.417 picograms per milliliter (pg/mL) | Standard Deviation 1466.214 |
Secondary
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.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS) | 5.6111 score on a scale | Standard Deviation 5.6375 |
| Pioglitazone | Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS) | 7.409 score on a scale | Standard Deviation 5.981 |
Secondary
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS) | 11.103 score on a scale | Standard Deviation 4.678 |
| Pioglitazone | Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS) | 9.577 score on a scale | Standard Deviation 5.994 |
Secondary
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.
Time frame: week 5
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 3.45 score on a scale | Standard Deviation 4.019 |
| Pioglitazone | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 2.5 score on a scale | Standard Deviation 2.502 |
Secondary
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.
Time frame: week 1
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 5.458 score on a scale | Standard Deviation 5.141 |
| Pioglitazone | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 3.458 score on a scale | Standard Deviation 3.538 |
Secondary
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.
Time frame: week 2
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 4.087 score on a scale | Standard Deviation 4.01 |
| Pioglitazone | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 3.435 score on a scale | Standard Deviation 3.116 |
Secondary
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.
Time frame: week 3
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 4.727 score on a scale | Standard Deviation 4.143 |
| Pioglitazone | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 2.95 score on a scale | Standard Deviation 3.236 |
Secondary
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.
Time frame: week 4
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 4.1 score on a scale | Standard Deviation 4.291 |
| Pioglitazone | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 2.524 score on a scale | Standard Deviation 4.308 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 5.862 score on a scale | Standard Deviation 4.991 |
| Pioglitazone | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 4 score on a scale | Standard Deviation 3.929 |
Secondary
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.
Time frame: week 6
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 2.895 score on a scale | Standard Deviation 3.053 |
| Pioglitazone | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 2.6 score on a scale | Standard Deviation 3.662 |
Secondary
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.
Time frame: week 7
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 2.842 score on a scale | Standard Deviation 2.566 |
| Pioglitazone | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 3.364 score on a scale | Standard Deviation 5.876 |
Secondary
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.
Time frame: week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 4.167 score on a scale | Standard Deviation 3.869 |
| Pioglitazone | Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A) | 2.952 score on a scale | Standard Deviation 4.226 |
Secondary
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.
Time frame: baseline, week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Drinking Habit as Assessed by the Number of Drinks Per Day (Timeline Followback Method) | -1.229 drinks per day | Standard Deviation 1.49 |
| Pioglitazone | Change in Drinking Habit as Assessed by the Number of Drinks Per Day (Timeline Followback Method) | -0.714 drinks per day | Standard Deviation 1.02 |
Secondary
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.
Time frame: baseline, week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Drinking Habit as Assessed by the Number of Heavy Drinking Days (Timeline Followback Method) | -5.5 Heavy drinking days | Standard Deviation 5.113 |
| Pioglitazone | Change in Drinking Habit as Assessed by the Number of Heavy Drinking Days (Timeline Followback Method) | -3.591 Heavy drinking days | Standard Deviation 4.152 |
Secondary
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.
Time frame: Week 1
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Stress as Assessed by the Perceived Stress Scale(PSS) | 15.208 score on a scale | Standard Deviation 7.407 |
| Pioglitazone | Stress as Assessed by the Perceived Stress Scale(PSS) | 14.583 score on a scale | Standard Deviation 6.928 |
Secondary
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.
Time frame: Week 2
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Stress as Assessed by the Perceived Stress Scale(PSS) | 13.522 score on a scale | Standard Deviation 7.988 |
| Pioglitazone | Stress as Assessed by the Perceived Stress Scale(PSS) | 14.783 score on a scale | Standard Deviation 6.915 |
Secondary
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.
Time frame: Week 3
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Stress as Assessed by the Perceived Stress Scale(PSS) | 13.318 score on a scale | Standard Deviation 6.785 |
| Pioglitazone | Stress as Assessed by the Perceived Stress Scale(PSS) | 14.19 score on a scale | Standard Deviation 8.116 |
Secondary
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.
Time frame: Week 4
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Stress as Assessed by the Perceived Stress Scale(PSS) | 12.65 score on a scale | Standard Deviation 9.08 |
| Pioglitazone | Stress as Assessed by the Perceived Stress Scale(PSS) | 14.143 score on a scale | Standard Deviation 6.24 |
Secondary
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.
Time frame: Week 5
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Stress as Assessed by the Perceived Stress Scale(PSS) | 12.55 score on a scale | Standard Deviation 8.787 |
| Pioglitazone | Stress as Assessed by the Perceived Stress Scale(PSS) | 12.227 score on a scale | Standard Deviation 7.237 |
Secondary
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.
Time frame: Week 6
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Stress as Assessed by the Perceived Stress Scale(PSS) | 13.8 score on a scale | Standard Deviation 6.478 |
| Pioglitazone | Stress as Assessed by the Perceived Stress Scale(PSS) | 12.429 score on a scale | Standard Deviation 7.427 |
Secondary
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.
Time frame: Week 7
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Stress as Assessed by the Perceived Stress Scale(PSS) | 11.7 score on a scale | Standard Deviation 5.966 |
| Pioglitazone | Stress as Assessed by the Perceived Stress Scale(PSS) | 12.455 score on a scale | Standard Deviation 8.629 |
Secondary
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.
Time frame: Week 8
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Stress as Assessed by the Perceived Stress Scale(PSS) | 11.222 score on a scale | Standard Deviation 7.224 |
| Pioglitazone | Stress as Assessed by the Perceived Stress Scale(PSS) | 12.318 score on a scale | Standard Deviation 6.284 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Stress as Assessed by the Perceived Stress Scale(PSS) | 14.276 score on a scale | Standard Deviation 7.892 |
| Pioglitazone | Stress as Assessed by the Perceived Stress Scale(PSS) | 12.808 score on a scale | Standard Deviation 7.731 |