Behavioral Strategies to Reduce Stress Reactivity in Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Change in Negative Affect
研究概览
简要总结
Opioid use disorder is a major public health problem. Although there are effective treatments for this disorder, many people still relapse and thus there is a need for new treatments to improve outcomes. People who have a strong emotional and physical response to stress are at a higher risk of relapse. The goal of this project is to test the effect of strategies to reduce response to stress in people diagnosed with opioid use disorder. Men and women diagnosed with opioid use disorder will be recruited for a one-session study. Participants will be randomly assigned to one of three brief instructional conditions followed by a brief laboratory stress test. Investigators hypothesize that, compared to education about stress, brief strategies to help people cope with negative emotions will reduce responses to stress and increase tolerance of stress. If this hypothesis is supported, it will inform the development of new treatments to improve outcome in opioid use disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
The study PI and data analyst will be blind to study condition. The experimenter will and participant will be aware of the study condition because this is a behavioral intervention.
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
- •18 years or older
- •primary diagnosis of opioid use disorder
- •ability to read and provide informed consent
排除标准
- •major psychiatric or medical condition that would interfere with the ability to complete study procedures
- •current opioid withdrawal
- •presence of another current substance use disorder at a severity requiring acute treatment
- •endocrine disease or current steroid prescription
- •opioid-positive urine drug screen or breath alcohol test on the data or enrollment (not including prescribed medications)
结局指标
主要结局
Change in Negative Affect
时间窗: Change measured over 2 time points during this 1-session study experiment (from start of a stress induction task to completion; approximately 10-15 minutes).
Negative affect will be measured using the Negative Affect Subscale of the Positive and Negative Affect Schedule. This is a 10-item self-report measure on which respondents rate how strongly they are experiencing negative emotion. The range of scores is 10-50, with higher scores representing higher negative affect.
Distress Tolerance
时间窗: Time-to-event outcome; during this 1-session study, this will measure time to outcome (discontinuation of task) from time of initiation of the stress induction task up to a maximum of 15 minutes later.
Distress tolerance will be measured using the Computerized Mirror Tracing Persistence Task. This is a computer-based task in which participants trace a mirror on the screen using the cursor. Participants are asked to persist at the task for as long as possible. Time to discontinuation is used as a measure of distress tolerance (in seconds). Longer duration reflects better tolerance of distress.
次要结局
- Change in Cortisol Response(Change measured over 2 time points during this 1-session study (from start of stress induction task to 30 minutes after completion; approximately 40-45 minutes).)
- Change in Skin Conductance Level(Change measured over 2 time points during this 1-session study (prior to and during the stress induction task; approximately 10-15 minutes).)
- Change in Opioid Craving(Change measured over 2 time points during this 1-session study (immediately prior to and at the completion of the stress induction task; approximately 10-15 minutes).)
研究者
McHugh, R. Kathryn
Assistant Professor
Mclean Hospital