Effects of Pioglitazone on Stress Reactivity and Alcohol Craving
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Pioglitazone
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Change in Drinking Habit as Assessed by the Number of Heavy Drinking Days (Timeline Followback Method)(baseline, week 8)
- Anxiety as Assessed by the Hamilton Anxiety Rating Scale(HAM-A)(week 8)
- Change in Drinking Habit as Assessed by the Number of Drinks Per Day (Timeline Followback Method)(baseline, week 8)
- Alcohol Craving as Assessed by the Pennsylvania Alcohol Craving Scale(PACS)(Week 8)
- Stress as Assessed by the Perceived Stress Scale(PSS)(Week 8)
研究者
Jin Ho Yoon
Assistant Professor
The University of Texas Health Science Center, Houston