Cannabidiol on reward-and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder: A Double-blind, Placebo-controlled, Cross-over Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Cue-reactivity
研究概览
简要总结
The purpose of this study is to determine the impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder on buprenorphine or methadone treatment.
详细描述
Individuals with opioid use disorder (OUD) demonstrate reward- and stress-related neurocognitive changes compared to individuals without OUD, including cravings for opioids in response to exposure to triggers, tendency to make impulsive and disadvantageous decisions, and a strong attentional bias towards drug-related cues. Together, these deficits are significant contributors to relapse and discontinuation of treatment. Cannabidiol (CBD) has been shown to impact some of these cognitive deficits but studies of CBD among individuals with OUD are mostly lacking. Therefore, this study aims to answer whether CBD has any impact on reward-related neurocognitive deficits in individuals with OUD. If successful, this line of research will lay the groundwork for future studies to evaluate CBD's impact on OUD treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind cross-over trial, in which the research staff and participants will be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Any self-reported use of cannabis or CBD products in the past 30 days
- •Baseline depression (PHQ9) or anxiety (GAD7) scores of greater than 10
- •Currently pregnant
- •Hepatic liver enzymes greater than 3x upper normal limit
- •Hypersensitivity to cannabinoids or sesame oil (CBD solution comes in sesame oil emulsion)
- •Currently taking any medications with known significant pharmacokinetic interactions with CBD
研究组 & 干预措施
Cannabidiol 600mg
All subjects will receive 600mg of oral cannabidiol in a double-blind fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL. Following administration, a battery of tests will be conducted to examine reward- and stress-related neurocognitive processes.
干预措施: Cannabidiol 100 MG/ML [Epidiolex] (Drug)
Placebo
All subjects will receive a matching placebo in a double-blind fashion. Following administration, a battery of tests will be conducted to examine the impact on reward- and stress-related neurocognitive processes.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Cue-reactivity
时间窗: Visit 2 and 3 (at least 1 week apart)
The primary outcomes is cue-induced cravings (Opioid Craving Scale). This was measured with a single 10-point likert scale asking about cravings, where 0 represented lower levels of craving and 10 indicated higher levels of cravings. This was given at 3 different time points, pre-cue, post-neutral, and post-drug images. Cue-induced craving is the difference between drug cue and pre-cue scores.
次要结局
- Decision Making(Visit 2 and 3 (at least 1 week apart))
- Stress-Reactivity (Physiological)(Visit 2 and 3 (at least 1 week apart))
- Delayed Discount(Visit 2 and 3 (at least 1 week apart))
- Attentional Bias(Visit 2 and 3 (at least 1 week apart))
- Stress-reactivity(Visit 2 and 3 (at least 1 week apart))
研究者
Joji Suzuki, MD
Director, Division of Addiction Psychiatry
Brigham and Women's Hospital