NCT04228276终止不适用
Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 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. rTMS may be a promising treatment option for SUD. In this study, we will demonstrate the feasibility of applying rTMS to Veterans with SUD, examine the efficacy 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
- 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
- •Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe
- •Last use of stimulants >1 and <6 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 social environment and housing to enable regular attendance at clinic visits.
- •Ability to undergo cognitive testing, functional magnetic resonance imaging (fMRI) scans, and rTMS (no contraindications)
- •Intelligence Quotient (IQ) > 80
- •Stable medical health
- •Veteran at Palo Alto VA's Addiction Treatment Services
排除标准
- •Pregnant or lactating female
- •History of prior adverse reaction to TMS
- •On medications thought to significantly lower seizure threshold, e.g.:
- •clozapine
- •chlorpromazine
- •clomipramine
- •bupropion > 400 mg/day
- •Use of direct dopaminergic antagonists or agonists
- •History of seizures 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 with study procedures, e.g. unstable angina
- •Unstable psychiatric symptoms that precludes consistent participation in the study, e.g.:
- •active current suicidal intent or plan
- •severe psychosis
- •Inability to undergo fMRI scan, e.g. claustrophobia, presence of ferromagnetic objects in subject's body
- •Other substance use disorder not in sustained remission
- •Chronic or recurring Axis I psychiatric condition preceding SUD other than PTSD
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 and after rTMS treatment)
研究者
研究点 (2)
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