rTMS for Stimulant Use Disorders (CTN-0108)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 8
- 主要终点
- Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period.
研究概览
简要总结
The purpose of the study is to determine feasibility of repetitive transcranial magnetic stimulation (rTMS) for individuals with moderate to severe cocaine or methamphetamine use disorder (CUD/MUD). Potential participants will be age 18-65, and interested in cutting down or stopping use. Participants will be randomized to one of two groups; groups will receive rTMS or sham rTMS (placebo) over the course of an 8-week treatment period, and complete follow-up assessments at the end of treatment, 12, and 16 weeks post-randomization.
详细描述
The study will be a randomized, double-blind, sham-controlled trial comparing rTMS vs. placebo delivered over an 8-week treatment period. After assessment and inclusion into the study, participants will be randomized to receive up to 30 sessions of either rTMS or placebo treatments. The target minimum number of rTMS/placebo treatments is 20 treatments over 8 weeks. The secondary objective is to gather preliminary data on the efficacy of rTMS for individuals with moderate to severe CUD or MUD. Follow-up visits occur at end of treatment and at 12- and 16-weeks following randomization.
Other study procedures:
Actigraphy: To assess daily sleep quality during weeks 1-8, the ActiGraph wristband device will record, sleep latency, sleep duration, and intervals of waking during the sleep period.
Electroencephalography (EEG): EEG will be obtained after randomization and again at week 4, to explore the potential for EEG to be used as a biomarker of treatment response.
Cognitive-Behavioral Educational Intervention: Participants in both conditions (rTMS and placebo) will be encouraged to participate in a mobile app-based educational intervention based on principles of Cognitive Behavioral Therapy (CBT) for Substance Use Disorder (SUD).
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
- Double (Participant, Investigator)
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
- •18-65, inclusive
- •Have a diagnosis of moderate or severe Cocaine or Methamphetamine Use Disorder (CUD/MUD) over the past 12 months (as determined by DSM-5 diagnostic criteria).
- •Have used cocaine or methamphetamine on at least 10 of the last 30 days (based on Timeline Follow-Back).
- •Be interested in decreasing cocaine and/or methamphetamine use.
- •If female, willing to use appropriate birth control method during the treatment phase of the study.
- •Be able to understand the study procedures and provide written informed consent to participate in the study.
- •If prescribed benzodiazepines or anticonvulsants, must be on a stable dose for at least 4 weeks prior to consent.
排除标准
- •A Diagnostic and Statistical Manual (DSM-5) diagnosis of moderate or severe SUD of any substance other than cocaine or methamphetamine based on DSM-
- •History of a serious medical disorder that, in the opinion of the Medical Clinician, would make it unsafe to participate in the study or may prevent collection of study data.
- •Is currently engaged in formal SUD treatment.
- •Documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
- •Documented history of brain lesion(s) and/or tumor(s).
- •Metal implants or non-removable metal objects above the waist.
- •Currently pregnant.
- •Lifetime history of prior clinical treatment with TMS.
- •Current or lifetime bipolar disorder.
- •Current psychotic disorder or psychotic depression.
- •Serious risk of homicide or suicide.
- •Are a prisoner or in police custody at the time of eligibility screening.
- •Previously randomized as a participant in the study.
- •Planned admission to a residential treatment facility or other formal SUD treatment program.
- •Unwilling or unable to follow study procedures.
结局指标
主要结局
Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period.
时间窗: From first treatment session (Week 1, first study visit) to end of treatment at 8 weeks
Treatment session attendance and completion will be tracked over the course of the study, and this record will constitute the primary feasibility outcome.
次要结局
- Negative UDS From Weekly UDS(From first treatment week (Week 1) to end of treatment at 8 weeks)
研究者
Kathleen Brady
Distinguished University Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Medical University of South Carolina