Development of a Novel, Scalable, Neurobiologically-Guided Transcranial Magnetic Stimulation Protocol for the Treatment of Cannabis Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Feasibility of study completion as assessed by completion rates
研究概览
简要总结
There has been a considerable rise in cannabis consumption in recent years, with estimates of 200 million individual users globally. Importantly, 3% of these individuals have cannabis use disorder (CUD), with this prevalence increasing to 33% amongst regular users, making it one of the most common substances use disorders (SUDs) worldwide. CUD is associated with substantial health, societal, and economic costs, and worsening of other psychiatric disorders. Despite this clinical burden, effective treatment options are limited. No pharmacological treatments have emerged as clearly efficacious, and psychotherapeutic interventions have shown tempered results.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of addictions. Evidence has indicated its efficacy in reducing drug craving and consumption across numerous SUDs, although research into cannabis has been largely unexplored. Recently, a novel circular rTMS coil, the MagVenture MMC-140, has been developed with the capacity to modulate both the bilateral prefrontal cortex (PFC) and insula, both of which are implicated in the neurocircuitry of craving and executive function. As such, it shows potential for CUD treatment.
This proof-of-concept clinical trial will evaluate the feasibility and tolerability of a 4-week course of rTMS to the PFC/insula using MMC-140 as a treatment for CUD. Feasibility of both high frequency (HF; excitatory) and low frequency (LF; inhibitory) stimulation parameters will be evaluated. In addition, pre/post rTMS changes in cannabis use outcomes (e.g., consumption, craving, and withdrawal), executive function, and PFC/insula functional connectivity will be explored. By comprehensively investigating clinical, cognitive, and neuroimaging effects of rTMS, this study could pave the way for the first brain-based intervention in CUD that could be widely adopted into clinical settings using a novel, cost-effective and accessible rTMS device.
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
- Single (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
- •Must be deemed to have capacity to provide informed consent
- •Age between 18 to 65
- •Diagnosis of cannabis use disorder according to the DSM-5 and the Structured Clinical Interview for DSM-5 (SCID for DSM-541)
- •Report cannabis as the primary drug of concern, a frequent pattern of use (≥5 days per week), and a goal of reduction or abstinence of cannabis use
- •CUDIT-R score ≥12
- •Marijuana Contemplation Ladder ≥7
- •Cannabis positive urine drug screen, with Narcochek baseline THC-COOH level of >150 ng/ml.
- •On a stable regimen of their psychotropic medications for 14 days before enrolment.
排除标准
- •Pregnant or intending to be pregnant during the study
- •Diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other active concurrent psychiatric disorder that is too unstable and may preclude safe participation in the trial as deemed by the PI.
- •Substance use disorder other than cannabis or nicotine, that is of moderate severity or greater, or is the primary substance of concern based on the SCID for DSM-5
- •Known active seizure disorder, significant head injury with an imaging verified lesion
- •Unstable medical illness
- •Presence of cardiac pacemaker, intracranial implant, or metal in the cranium
- •Participants taking > 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.
结局指标
主要结局
Feasibility of study completion as assessed by completion rates
时间窗: The timeframe is through study completion, beginning from baseline to end of rTMS treatment week 4, an average of 8 weeks, the event determined by withdrawal from the study.
Feasibility is determined by completion of the study and all associated study assessments, without withdrawing or being withdrawn from the study. Withdrawal from the study can be dropping out for any reason, including intolerability, serious adverse events, or inability to adhere to study procedures.
Tolerability of Intervention as assessed by adverse event reporting
时间窗: The timeframe is through study completion, beginning from baseline to end of rTMS treatment week 4, an average of 8 weeks. The events being counts of adverse events or serious adverse events.
This will be assessed through a side effect report at each treatment session. Safety monitoring will be implemented through the documentation and monitoring of adverse events (AEs) and serious adverse events (SAEs) using incidence tables by severity, relationship to treatment and baseline parameters.
次要结局
- Cannabis Use(Baseline (pre-rTMS), Weekly (end of each week of rTMS), Follow-up (4-weeks post-rTMS), up to a total time frame of 8 weeks. Events are counted as self reported instances of cannabis use on the Timeline Followback.)
- Cannabis Craving(Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, Follow-up (4-weeks post-rTMS),)
- Cannabis Withdrawal(Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, Follow-up (4-weeks post-rTMS),)
- Prefrontal cortex and Insula Connectivity(Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS))
- Depression symptoms(Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS),)
- Anxiety symptoms(Baseline (pre-rTMS), Weekly (end of each week of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS),)
- Trail Making Test(Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS))
- Hopkins Verbal Learning Test(Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS))
- Digit Span(Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS))
- Continuous Performance Test(Baseline (pre-rTMS), End of rTMS (end of treatment week 4 of rTMS), an average of 8 weeks from baseline assessment to end of rTMS, follow-up (4-weeks post-rTMS))