Transcranial Magnetic Stimulation for Treating Patients Under Methadone Maintenance Therapy Combined With Methamphetamine Abuse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Self-report drug use and urine test
研究概览
简要总结
Repetitive transcranial magnetic stimulation (rTMS) has been used to treat opioid and methamphetamine addiction in previous studies, while no evidence was proved for patients methadone maintenance therapy with methamphetamine abuse. The aim of this study is to evaluating the effectiveness and safety of rTMS treatment for methamphetamine abuse in patients with methadone maintenance therapy.
详细描述
First, a multicenter, double-blind, randomized control study is going to be carried out. 60 recruited patients will be randomized assigned to the intervention group (40) and the control group (20), receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS) treatment or 4-week of sham rTMS treatment. Both groups will receive 16-week urine drug test (1 time per week, 4 weeks before rTMS, 4 weeks during rTMS and 8 weeks after rTMS). Self-report methamphetamine use or urine test is set as primary outcome. Cognitive function and craving are also evaluated before and after the intervention. Functional magnetic resonance imaging (fMRI) is applied to investigate the potential neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an evidence-based rTMS treatment protocols for methadone maintenance therapy with methamphetamine abuse and decrease risk of relapse for both the patients and their families.
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, Care Provider, 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
- •aged 18-65 years
- •a diagnosis of OUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and current enrollment in MMT
- •a diagnosis of methamphetamine (MA) use disorder according to the DSM-5
- •four or more positive methamphetamine urine tests within a 4-week period
- •no concurrent medication treatment except for methadone
- •an education level of junior high school or higher
- •normal vision and hearing
排除标准
- •severe physical or neurological conditions requiring active treatment (e.g., stroke, seizure, or traumatic brain injury)
- •use of cognition-enhancing medications within the past 6 months
- •other substance use disorders (excluding nicotine dependence) in recent five years
- •comorbid severe psychiatric disorders (e.g., bipolar disorder, schizophrenia, or major depressive disorder)
- •pregnancy or lactation among female participants
- •contraindications for iTBS, such as implanted devices (e.g., pacemakers, cochlear implants, neurostimulators) or intraocular metal fragments
研究组 & 干预措施
rTMS treatment group
For rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 4 weeks.
干预措施: repetitive transcranial magnetic stimulation (rTMS) (Device)
sham rTMS treatment group
For sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday. Treatment will lasted for 4 weeks.
干预措施: sham repetitive transcranial magnetic stimulation (rTMS) (Device)
结局指标
主要结局
Self-report drug use and urine test
时间窗: 16 weeks
Patients will be asked to report their drug use for 16 weeks every day and do urine tests once a week for 16 weeks. Loss of visit or rejecting to report or rejecting to do urine tests will be treated as drug use positive (relapse).
次要结局
- Change of Craving assessed by Visual Analog Scale(12 weeks)
- Functional magnetic resonance imaging(4 weeks)
- Cognitive function assessed by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(12 weeks)
- Cognitive function assessed by RBANS(4 weeks)
- Magnetic resonance imaging(4 weeks)
- Safety measurements(12 weeks)