Feasibility Study on the Use of an Intensive Deep Transcranial Magnetic Stimulation Protocol in the Treatment of Cocaine and Other Stimulants Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility-related endpoints - adherence to dTMS
研究概览
简要总结
The purpose of the study is to explore the Feasibility, Tolerability and Safety of the H7-Coil deep Transcranial Magnetic Stimulation for Subjects with Stimulants Use Disorder (SUD).
详细描述
Stimulants Use Disorder (SUD) is a major public health issue, with potentially severe psychosocial and medical consequences. Even though psychosocial therapies exist, an important proportion of patients do not respond to these approaches, and no approved biological approaches are currently available. deep TMS (dTMS) has been shown effective for Major Depressive Disorder, Obsessive Compulsive Disorder and Nicotine Use Disorder and could also prove available for SUD. Several pilot studies have shown preliminary effectiveness in SUD, but are limited by the length of their protocol, which could result in limited real-world effectiveness secondary to high dropout rates. Given that aTMS protocols have been applied successfully in MDD, we propose to implement this approach for SUD, in order to reduce treatment length and therefore increase retention rates. We will also gather preliminary data on various biomarkers that could help predict response and better understand biological mechanisms behind SUD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with SUD (moderate or severe) based on DSM-5 criteria
- •Current stimulants use with last use in the two weeks prior to admission to the study as confirmed by the Timeline Followback Questionnaire
- •Wanting to stop the intake of stimulants
- •Being able and willing to adhere to the treatment schedule
- •Filling the criteria of the TMS adult safety screening (TASS) questionnaire
- •Being voluntary and competent to consent to treatment
- •Ability to speak and read French or English
排除标准
- •Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder); current acute psychosis, mania or active suicidality (unipolar major depression, anxiety disorders and personality disorders will be allowed as long as they are not primary and causing greater impairment than SUD)
- •Severe and/or unstable medical illness, including but not limited to any neurologic, cardiac, renal or hepatic condition
- •Implanted medical device (including but not limited to intracranial implants, cardiac pacemaker, medication pump, etc.) or intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- •Clinically significant laboratory abnormality, in the opinion of the principal investigator
- •Pregnancy or breastfeeding
- •Another current severe substance use disorder (except nicotine)
- •Anti-craving medication and other psychotropic medications are allowed, but need to have been stable for four (4) weeks before screening
- •Currently taking more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit TMS efficacy.
- •Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with the interview)
结局指标
主要结局
Feasibility-related endpoints - adherence to dTMS
时间窗: after 10 days of treatment sessions
Number of completer treatment sessions
Adverse Events reported
时间窗: up to three months after end of the treatment
Adverse events reported
Feasibility-related endpoints - retention rates
时间窗: after 10 days of treatment sessions
Number of patients who did not completed the total (40) sessions
次要结局
- Percentage change on General Anxiety Disorder (GAD-7)(T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14))
- Percentage change on Stimulants Selective Severity Assessment(T0 (week 0), T1 (end of treatment, week 2), T2 (week 4), T3 (week 6), T4 (week 14))
- Percentage change on Stimulants Craving Questionnaire(T0 (week 0), T1 (end of treatment, week 2), T2 (week 4), T3 (week 6), T4 (week 14))
- Percentage of Positive Urine Drug Screen to Stimulants(up to three months after end of the treatment)
- Percentage change on Patient Health Questionnaire (PHQ-9)(T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14))