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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
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.
Pill capsules will look same as that of active drug.
The University of Texas Health Science Center of Houston
Houston, Texas, United States
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
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
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
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
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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