Functional Connectivity Mechanisms of Opioid Abstinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Illicit opioid-use
研究概览
简要总结
This project examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for OUD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recent initiation of methadone or buprenorphine at a clinic, program, or doctor within the past year (i.e., period of time during which treatment drop-out and risk for relapse is highest);
- •eligibility for MRI scanning;
- •ability to commit to study visits.
排除标准
- •current acute psychosis, mania, or suicidal ideation with intent, as assessed during screening with the SCID-5;
- •current intoxication or acute withdrawal at time of study visit sufficient to prevent participation based on: behavioral observation, breathalyzer, and SOWS assessment;
- •severe cognitive impairment as determined via trained clinical research staff through consent process and during consent quiz or as indicated by a PROMIS Cognitive Function tscore <30 (i.e., severe impairment)
- •past or present history of intellectual disability, developmental disorder, or neurological disease;
- •head trauma with loss of consciousness >30 min;
- •organ dysfunction or any unstable or untreated medical conditions that may interfere with study participation.
研究组 & 干预措施
Methadone
Participants initiated into methadone within the past 6 months will receive fMRI and cognitive assessment battery.
干预措施: fMRI (Diagnostic Test)
Buprenorphrine
Participants initiated into buprenorphine within the past 6 months will receive fMRI and cognitive assessment battery.
干预措施: fMRI (Diagnostic Test)
结局指标
主要结局
Illicit opioid-use
时间窗: At monthly visits for 6 months following neuroimaging
Defined as the percent days of self-reported use of illicit opioids (assessed at monthly visits for 6-months following neuroimaging), with the exception of primary type of MOUD (i.e., methadone for methadone treated individuals, buprenorphine for buprenorphine treated individuals).
次要结局
- MOUD retention(up to 9 months)