Transcranial Magnetic Stimulation (TMS) to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Engagement in Treatment As Usual Activities
研究概览
简要总结
The study aims to explore the potential of Transcranial Magnetic Stimulation (TMS), particularly Theta Burst Stimulation (TBS), as an adjunctive treatment to enhance recovery outcomes (consumption and craving; withdrawal symptoms; mental, physical, sleep, and cognitive health; engagement with therapy, etc.) in individuals with Opioid Use Disorder (OUD) and individuals with Alcohol Use Disorder (AUD). This project will be completed in partnership with Another Chance Rehab (Portland): Portland's top addiction treatment program offering evidence-based treatment programs for a range of substance use disorders. Another Chance Rehab will serve as the project site for this work.
详细描述
The investigators will conduct a prospective, randomized, controlled trial. To identify which TMS protocol is most efficacious, there will be three arms to this study.
- Treatment as Usual (TAU): Participants complete their regularly scheduled therapy activities and receive no add-on TMS. They will answer the demographic survey and outcome measure surveys (listed in a later section).
- TAU + 3-minute TMS: Participants complete TAU as described above, with one 3-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).
- TAU + 9-minute TMS: Participants complete TAU as described above, with one 9-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).
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
- None
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 old
- •Enrolled in the Intensive Outpatient Program at Another Chance Drug & Alcohol Rehab Center of Portland, Portland, OR.
- •Diagnosed with Opioid Use Disorder
- •Diagnosed with Alcohol Use Disorder
排除标准
- •Children <18 years old
- •Non-English speaking
- •Currently taking prescription benzodiazepines or anti-convulsive medications
- •In active alcohol or opioid withdrawal
- •History of seizure disorder diagnosis
- •History of Schizophrenia, Bipolar Disorder, Mania
研究组 & 干预措施
Treatment As Usual
Study participants in this arm will engage in intensive outpatient alcohol and addiction treatment provided as it usually is for all patients in this program.
3-Minute TMS
TAU + 3-minute TMS: Participants complete TAU as described above, with one 3-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).
干预措施: TMS Low-Dose (Device)
9-Minute TMS
TAU + 9-minute TMS: Participants complete TAU as described above, with one 9-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).
干预措施: TMS High-Dose (Device)
结局指标
主要结局
Engagement in Treatment As Usual Activities
时间窗: 4 weeks
Number of individual treatment sessions attended from baseline assessment to follow up.
Engagement in Treatment As Usual activities
时间窗: 4 weeks
The Investigators will compare engagement in treatment as usual within and between groups by Number of Days in attendance from baseline assessment to follow up.
次要结局
- Delay Discounting(4 weeks)
- Go/No-Go Task(4 weeks)
- Balloon Analogue Risk Task(4 weeks)
- Barratt Impulsiveness Scale-11(4 weeks)
- Sensation Seeking Scale(4 weeks)