The Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Opioid Use Disorders: Analysis of Clinical Outcomes, Functional Magnetic Resonance Imaging, Biomarkers, and Neuropsychological Tests
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The treatment attendance rate
研究概览
简要总结
Opioid use disorder (OUD) is prevalent and causes substantial health and social burdens. Although evidence have showed the effectiveness of opioid agonist maintenance therapy in OUD, high drop-out rate and the requirement of continuing use of opioid agonists are the major problems. Therefore, to develop novel treatment for OUD is important.
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method of brain stimulation used to treat a variety of neuropsychiatric disorders. Recent studies showed that there may be potential therapeutic effects in rTMS for addictive disorder, including reducing craving and substance use severity. The underlying mechanisms of rTMS in treating addictions may involve increased dopamine function in corticomesolimbic brain circuits and modulation of neural activity in brain circuits that relevant to addiction. However, the treatment results of rTMS in OUD were lacked, and the analysis in functional brain imaging study, neuropsychological tests and other potential biomarkers under rTMS treatment were limited, too.
Thus, the investigators will conduct the add-on double-blinded, sham-controlled study rTMS treatment in 40-60 patients with OUD under methadone maintenance therapy. Patients will be allocated to active and sham rTMS in a 1 : 1 ratio, and participants will receive rTMS on the left dorsolateral prefrontal cortex (DLPFC) (15 Hz frequency, 4 seconds per train, inter-train interval of 26 seconds, 40 trains per session, total 11 sessions in 4 weeks). The treatment response, urine drug tests, craving scales and side effects to evaluate the therapeutic effects of rTMS will be examined. Neuropsychological assessments, functional magnetic resonance imaging (fMRI) and tests for potential biomarkers of immune parameters will also be measured during 12-weeks follow up. The study results will provide the important data in whether rTMS add-on methadone maintenance therapy is able to 1) reduce heroin use; 2) reduce craving for heroin; 3) be an effective treatment for OUD, and 4) be associated with improvement in fMRI, biological markers and psychological tests.
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)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent by patient or legal representative.
- •Male or female patient aged ≧20 and ≦65 years.
- •A diagnosis of OUD according to DSM criteria made by a specialist in psychiatry.
- •Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
排除标准
- •Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study.
- •Females who are pregnant or lactation.
- •Current evidence of an uncontrolled and/or clinically significant medical condition, e.g.,cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation.
- •History of seizure or epilepsy.
- •History of neurological diseases or traumatic brain injury.
- •Suicidal attempts or risks during screen or study period.
- •Presence of devices, e.g. pace-makers, cochlear prosthesis, neuro-stimulators, magnetic cochlear prosthesis, intraocular metallic fragments.
- •Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first intervention of the double-blinded treatment.
结局指标
主要结局
The treatment attendance rate
时间窗: 12 weeks
To compare the treatment attendance rate between the active and sham rTMS groups from baseline to endpoint (12 weeks).
The treatment retention rate
时间窗: 12 weeks
To compare the treatment retention rate between the active and sham rTMS groups from baseline to endpoint (12 weeks).
Urinary assessment
时间窗: 12 weeks
Urinary morphine examinations will be measured at every visit. The rate of positive urinary morphine tests will be compared between active and sham rTMS groups in 12 weeks of follow up.
次要结局
- Immunological markers(12 weeks)
- Wisconsin Card Sorting Test(WCST)(12 weeks)
- Side effect checklist(12 weeks)
- fMRI(5 weeks)
- Wechsler Memory Scale - third edition(WMS-III)(12 weeks)
- 17-item Hamilton Depression Rating Scale (HDRS)(12 weeks)
- Family APGAR index(12 weeks)
- Continuous performance tests(CPT)(12 weeks)
- Assessment of craving(12 weeks)
- Barratt Impulsiveness Scale(BIS)(12 weeks)
- World Health Organization's Quality of Life Assessment-Brief of Taiwan (WHOQOL-BREF TW)(12 weeks)
- The Opiate Treatment Index (OTI)(12 weeks)
- Clinical Global Impressions (CGI)(12 weeks)
研究者
Tzu-Yun Wang
Doctor
National Cheng-Kung University Hospital