Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tolerability
研究概览
简要总结
The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes.
详细描述
In a randomized double-blind parallel-group sham-controlled design (n=20) administer a 5-day accelerated iTBS protocol (40 treatments) to the left dorsolateral prefrontal cortex during a short inpatient stay. Magnetic resonance imaging will be completed pre-post TMS and participants will be followed for 12 weeks.
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)
盲法说明
Participant and all study personnel are blinded.
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
- •Age 21-65 years inclusive;
- •Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;
- •By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;
- •Provides a urine drug screen positive for methamphetamine;
- •Able to provide informed consent;
- •No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry;
- •Adequate English proficiency for study consent, and completion of the study instruments.
排除标准
- •Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;
- •Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;
- •Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;
- •Current clinically significant neurological disorder or medical illness, including history of seizures, cardiovascular disease/cardiac event, which in the opinion of the study physician would make study participation unsafe;
- •Presence of a clinically significant abnormality on baseline MRI;
- •Inability to have an MRI;
- •Currently breastfeeding, is currently pregnant or lack of use of effective contraception in women of childbearing age, as assessed by urine pregnancy test and self-report (participants will consent to continue effective contraceptives during the study);
- •Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);
- •History of head injury with loss of consciousness for more than 15 minutes;
- •Diagnosis of dementia;
- •Prescribed benzodiazepines or anticonvulsants;
- •Currently enrolled in formal substance use disorder treatment;
- •Metal implants or non-removable metal objects above the waist;
- •Lifetime history of prior clinical treatment with TMS;
- •Serious risk of suicide or homicide;
- •Unable/unwilling to follow the study procedures;
- •History of intractable migraine;
- •Assessed to be at risk for alcohol or opioid withdrawal.
结局指标
主要结局
Tolerability
时间窗: 5 days
Proportion completing at least 20 TMS session - sham vs. active
Study emergent adverse events
时间窗: 12 weeks
Incidence of study emergent adverse events - sham vs. active
次要结局
- Weeks of continuous abstinence(12 weeks)
- Days of methamphetamine use(12 weeks)
- Methamphetamine craving(12 weeks)
- Methamphetamine craving on visual analog scale(12 weeks)
- MRI cue craving(Pre- and Post- TMS stimulation in week 1)
- MRI resting state(Pre- and Post- TMS stimulation in week 1)
- Weeks of continuous abstinence(12 weeks)
- Days of methamphetamine use(12 weeks)
- Time to first methamphetamine use(12 weeks)
- Methamphetamine craving(12 weeks)
- Methamphetamine craving on visual analog scale(12 weeks)
- MRI cue craving(Pre- and Post- TMS stimulation in week 1)
- MRI resting state(Pre- and Post- TMS stimulation in week 1)