Neurofeedback in Individuals With Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Opioid Use: Urine Tests
研究概览
简要总结
The aim of this study is to train individuals with opioid use disorder to control their brain activity in a way that has been associated with their symptoms. Participants in the experimental group will be given direct feedback regarding their brain activity while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control their brain activity during these feedback sessions. A separate group of participants will be given a control form of feedback that we do not believe can have clinical benefits. Our primary hypothesis is that the neurofeedback training will reduce opioid use and clinical features of opioid use disorder more than the control feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded as to whether they are receiving experimental or control neurofeedback.
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
- •non-methadone opioid positive urine screen (as assessed during standard treatment) or indicated via Utox or self-reported past-month opioid use at screening
- •Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for opioid use disorder, as assessed via structured clinical interview (SCID)
- •≥3 months of methadone treatment
排除标准
- •Having any current neurologic or psychiatric disorders including current moderate to severe other DSM-5 substance use disorders with the exceptions of opioids, cocaine, tobacco and cannabis, as assessed using the SCID.
- •Failure to pass a magnetic resonance imaging (MRI) screening
- •Having significant underlying medical conditions requiring medications.
- •Women who are pregnant or nursing
- •Baseline scanning with excessive motion based on frame to frame displacement
结局指标
主要结局
Opioid Use: Urine Tests
时间窗: Baseline (week 1) to one month post follow-up (week 9)
Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests.
Opioid Use: Timeline Followback Method (TLFB)
时间窗: Baseline (week 1) to one month post follow-up (week 9)
Opioid use assessed using the timeline followback method (TLFB). TLFB asks subjects to estimate drug use during a specific time period in the past. Number of participants positive or negative for drug use.
次要结局
- Mean Change in Functional Connectivity Patterns in the Brain(Baseline (week 1) through follow up (week 5))
- Mean Opioid Craving Score(Baseline (week 1) to one month post follow-up (*week 9*))
- Negative Affect Mean Score(Baseline (week 1) to one month post follow-up (week 9))