Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pioglitazone
干预措施: Pioglitazone (Drug)
Placebo
干预措施: Placebo (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: baseline, week 4
The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and heart rate will be measured before and after CPT. The heart rate change for each time point is calculated as heart rate after CPT minus the heart rate before CPT. This outcome measure reports the heart rate change at week 4 minus the heart rate change at baseline.
Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)
时间窗: baseline, week 4
The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and blood pressure will be measured before and after CPT. The blood pressure change for each time point is calculated as blood pressure after CPT minus the blood pressure before CPT. This outcome measure reports the blood pressure change at week 4 minus the blood pressure change at baseline.
Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)
时间窗: baseline, week 4
The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and blood pressure will be measured before and after CPT. The blood pressure change for each time point is calculated as blood pressure after CPT minus the blood pressure before CPT. This outcome measure reports the blood pressure change at week 4 minus the blood pressure change at baseline.
Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)
时间窗: baseline, week 4
The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and salivary cortisol level will be measured before and after CPT. The salivary cortisol level change for each time point is calculated as salivary cortisol level after CPT minus the salivary cortisol level before CPT. This outcome measure reports the salivary cortisol level change at week 4 minus the salivary cortisol level change at baseline.
Change in Stress-reactivity as Assessed by Self-report on a Visual Analogue Scale (VAS)
时间窗: baseline, week 4
The visual analogue scale (VAS) ranges from 0-10, with a higher score indicating higher stress.
次要结局
- Change in Alcohol Use as Indicated by Self Report Using the Alcohol Timeline Followback (TLFB)(baseline, week 4)
- Change in Alcohol Craving as Assessed by Self Report Using the The Penn Alcohol Craving Scale (PACS).(baseline, week 4)
研究者
Jin Ho Yoon
Assistant Professor
The University of Texas Health Science Center, Houston