Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- craving
研究概览
简要总结
Deep TMS to the left dorsolateral prefrontal cortex intervention to reduce craving and recurrent opioid use among patients with opioid use disorder who are abstinent for at least one week.
详细描述
The participants will undergo baseline assessments, including rating scales and urine opioid metabolite tests. The participants will receive one of two treatments: High-frequency (10Hz, 3000 pulses per session) dTMS using a double cone coil targeting the left dorsolateral prefrontal cortex or sham stimulation. Each treatment will be preceded by a short-guided imagery (2-3 min) design to activate the relevant brain circuitry (provocation of symptoms may increase the response rate to deep TMS as was evident in the treatment of PTSD, cigarette smoking, and OCD). dTMS sessions will be conducted 10 times per week for 2 weeks, for 20 sessions. 8 weeks of patient follow-up, including clinical visits at weeks 0, 2, and 8. During this phase, subjective and objective measures of opioid use (self-report and analysis of urine samples for opioid metabolite) will be collected. Following the completion of the main part by the individual, an "open-label" treatment using the same parameters of the experiment will be offered (regardless of the treatment group).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age 18- 65
- •Clinical diagnosis of opioid use disorder
排除标准
- •Currently pregnant or breastfeeding
- •Mental retardation, bipolar disorder, any psychotic disorder
- •Neurological diseases such as epilepsy, ischemic stroke, multiple sclerosis
- •History of head trauma that resulted in loss of consciousness for ≥5 minutes and retrograde amnesia for ≥30 minutes (self-reported history)
- •Any history of seizures other than febrile childhood seizures (self-reported history)
- •Clinically significant hearing impairment
- •Having any prosthesis, such as an implant and pacemaker.
- •Illiteracy
结局指标
主要结局
craving
时间窗: pretreatment, 2 weeks, and 8 weeks
craving severity for drug use- Visual Analog Scale (VAS). The minimum and maximum values are 0-10. Higher scores mean a worse outcome.
次要结局
- Opioid use(8 weeks of treatment)
- Impulsivity severity(pretreatment, 2 weeks, and 8 weeks)
- Depression severity(pretreatment, 2 weeks, and 8 weeks)
- Anxiety severity(pretreatment, 2 weeks, and 8 weeks)
研究者
Bengü Yücens
Medical Doctor, Associate Professor
Pamukkale University