Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Number of Participants Relapsed
研究概览
简要总结
The purpose of this study is to establish a new treatment (repetitive transcranial stimulation (rTMS)) for Veterans with stimulant use disorder (SUD). Despite the large public health burden imposed by SUD, there is currently no FDA-approved or widely recognized effective somatic treatment. This placebo controlled study will test the effectiveness of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study in which participants, staff administering treatment, investigators, and outcome assessors are all masked to group assignments.
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
- •Must be a U.S. Veteran
- •Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe
- •Last use of stimulants >2 and <8 weeks
- •Stable medication regimen (no change in dose or agents between 2 weeks prior to the start of and throughout the treatment phase of the study)
- •Stable medical health
排除标准
- •Pregnant or lactating female
- •History of prior adverse reaction to Transcranial magnetic stimulation (TMS)
- •On medications thought to significantly lower seizure threshold, e.g. clozapine, chlorpromazine, clomipramine, and bupropion > 400mg/day
- •Seizure disorder or conditions known to substantially increase risk for seizures
- •Implants or medical devices incompatible with TMS
- •Acute or unstable chronic medical illness that would affect participation or compliance in the study, e.g. unstable angina
- •Unstable psychiatric symptoms that precludes consistent participation in the study, e.g. active current suicidal intent or plan; severe psychosis
- •Other substance use disorder not in remission
- •Chronic or recurring Axis I psychotic disorders
- •For subjects participating in functional magnetic resonance imaging (fMRI) scans, presence of ferromagnetic material in their body or taking DAergic medications
研究组 & 干预措施
Active rTMS
Receive active rTMS
干预措施: Repetitive transcranial magnetic stimulation (rTMS) (Device)
Sham rTMS
Receive sham rTMS
干预措施: Sham rTMS (Device)
结局指标
主要结局
Number of Participants Relapsed
时间窗: 3 months after last rTMS treatment
Rate of stimulant use relapse compared between active vs. sham rTMS groups
次要结局
- Reward circuit function and signaling(Within 1 week before rTMS treatment and within 1 week after rTMS treatment)