Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms
概览
- 阶段
- 不适用
- 干预措施
- Placebo
- 疾病 / 适应症
- Opioid Use Disorder
- 发起方
- Vanderbilt University Medical Center
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean change in McGill Pain Questionnaire-2 (MPQ-2) ratings of low back pain from the placebo to oxycodone condition
- 状态
- 招募中
- 最后更新
- 6个月前
概览
简要总结
The purpose of this study is to see how stress influences the effects of opioid pain medications often used to help relieve back pain. The study will help to learn more about how high stress levels could increase risk for pain medication misuse.
详细描述
The purpose of this project is to advance mechanistic knowledge of how stress impacts differential opioid analgesic responses that enhance risk for opioid use disorder (OUD), potentially informing development of data-driven precision pain medicine algorithms to mitigate opioid related risks. The study aims to determine whether subjective and physiological stress-related measures are associated with analgesic and misuse-relevant subjective responses to placebo-controlled oxycodone administration. The study also aims to evaluate associations between stress-related measures and both endogenous opioid (EO) function and endocannabinoid (EC) levels and to test whether EO and EC mechanisms contribute to associations between stress-related measures and oxycodone responses Using a mixed between/within-subject design, the study will obtain baseline assessment of stress related markers followed by 3 laboratory sessions with assessment of endocannabinoids, back pain assessment, and exposure to standardized evoked pain stimuli after administration of placebo, naloxone, and oxycodone.
研究者
Stephen Bruehl, PhD
Professor of Anesthesiology
Vanderbilt University Medical Center
入排标准
入选标准
- •Intact cognitive status and ability to provide informed consent
- •Ability to read and write in English sufficiently to understand and complete study questionnaires (which are only validated in English)
- •Age 18 or older And
- •Presence of persistent daily low back pain of at least three months duration and of at least a 3/10 in average intensity
排除标准
- •History of renal or hepatic dysfunction
- •Reports of current or past alcohol or substance abuse or treatment for such condition
- •A reported history of PTSD, psychotic, or bipolar disorders
- •Chronic pain due to malignancy (e.g., cancer) or autoimmune disorders (e.g., rheumatoid arthritis, lupus)
- •Reports of recent benzodiazepine use (confirmed via rapid urine screening prior to each lab session)
- •Any medical conditions (e.g., significant cardiovascular disease) that the study physician feels would contraindicate participation in the lab stressors
- •Reported daily opiate use within the past 6 months, or use of any opioid analgesic medications within 3 days of study participation (confirmed through rapid urine screening prior to each lab session)
- •Pregnancy (females only, to avoid fetal drug exposure - pregnancy tests conducted prior to each lab session to confirm eligibility)
- •Prior allergic reaction/intolerance to oxycodone or its analogs
研究组 & 干预措施
Adults with chronic non-cancer low back pain
干预措施: Placebo
Adults with chronic non-cancer low back pain
干预措施: Oxycodone
Adults with chronic non-cancer low back pain
干预措施: Naloxone
结局指标
主要结局
Mean change in McGill Pain Questionnaire-2 (MPQ-2) ratings of low back pain from the placebo to oxycodone condition
时间窗: Across 2 laboratory assessment days (an expected average of 15 day period)
Mean within participant changes in McGill Pain Questionnaire-2 (MPQ-2) ratings of low back pain from the placebo to oxycodone condition (across 2 testing days). The MPQ-2 score ranges from 0-10 where 0 represents no pain and 10 represents most intense pain. Positive change values indicate decreased pain responsiveness post intervention.
Mean DELTA Drug Liking subscale scores in the oxycodone condition
时间窗: One 1 laboratory assessment day
Mean DELTA Drug Liking subscale scores in the oxycodone condition. The DELTA Drug Liking subscale consists of a single item asking about overall perceived drug liking. The 1-5 scale is anchored with 1 representing dislike a lot and 5 representing like a lot.
Composite measure of changes in MPQ-2 ratings of low back pain from the placebo to naloxone condition (standardized) plus plasma levels of endocannabinoids (standardized)
时间窗: Across 2 laboratory assessment days (an expected average of 15 day period)
Composite measure of changes in MPQ-2 ratings of low back pain from the placebo to naloxone condition (standardized) plus plasma levels of endocannabinoids (standardized). More negative standardized values will indicate low levels of endogenous pain inhibition and more positive levels will indicate high levels of endogenous pain inhibition.
次要结局
- Mean changes in MPQ-2 ratings of ischemic task pain from the placebo to oxycodone condition(Across 2 laboratory assessment days (an expected average of 15 day period))
- Mean changes in Visual Analog Scale (VAS) intensity ratings of ischemic task pain from the placebo to oxycodone condition(Across 2 laboratory assessment days (an expected average of 15 day period))
- Mean changes in MPQ-2 ratings of heat task pain from the placebo to oxycodone condition(Across 2 laboratory assessment days (an expected average of 15 day period))
- Mean changes in VAS intensity ratings of heat task pain from the placebo to oxycodone condition(Across 2 laboratory assessment days (an expected average of 15 day period))
- DELTA Take Again subscale scores in the oxycodone condition(1 laboratory assessment day (an expected average of 15 day period))
- Mean Delta Effects subscale in the oxycodone condition(1 laboratory assessment day (an expected average of 15 day period))
- Mean VAS Opioid Euphoria subscale in the oxycodone condition(1 laboratory assessment day (an expected average of 15 day period))
- Mean VAS Opioid Unpleasantness subscale in the oxycodone condition(1 laboratory assessment day (an expected average of 15 day period))
- Mean VAS Opioid Sedation subscale in the oxycodone condition(1 laboratory assessment day (an expected average of 15 day period))
- Mean change in McGill Pain Questionnaire-2 (MPQ-2) ratings of low back pain from the placebo to naloxone condition(Across 2 laboratory assessment days (an expected average of 15 day period))
- Mean change in McGill Pain Questionnaire-2 (MPQ-2) ratings of ischemic task pain from the placebo to naloxone condition(Across 2 laboratory assessment days (an expected average of 15 day period))
- Mean changes in VAS intensity ratings of ischemic task pain from the placebo to naloxone condition(Across 2 laboratory assessment days (an expected average of 15 day period))
- Mean change in McGill Pain Questionnaire-2 (MPQ-2) ratings of heat task pain from the placebo to naloxone condition(Across 2 laboratory assessment days (an expected average of 15 day period))
- Mean changes in VAS intensity ratings of heat task pain from the placebo to naloxone condition(Across 2 laboratory assessment days (an expected average of 15 day period))
- Mean plasma levels of endocannabinoids(Across 3 laboratory assessment days (an expected average of 15 day period))