A Double Blind, Sham Controlled Trial of Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving and Impulsive Decision Making in Cannabis Use Disordered Participants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Marijuana Craving Questionnaire (MCQ)
研究概览
简要总结
This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking Cannabis use disordered participants. Participants will then undergo either active, or sham rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed.
详细描述
Our primary aims are to determine the effect of a single session of 10 Hz L DLPFC rTMS on cannabis cue induced craving (Aim1), and behavioral tasks of impulsive decision making (Aim2), in non-treatment seeking individuals with Cannabis Use Disorder. The aims of the study will be accomplished by performing a double-blind, sham-controlled crossover trial. Non-Treatment seeking individuals with CUD will be recruited through media advertisements, as well as via a pre-established database of non-treatment seeking individuals who have participated in previous Cannabis trials and agreed to be re-contacted. Interested individuals will undergo a brief phone screen to determine if they meet general inclusion/exclusion criteria, and if so will be invited to meet with study personnel in order to sign informed consent, and undergo a screening visit. There will then be two experimental visits separated by at least one week. During each of these visits participants will undergo either a real, or sham rTMS treatment, as well as a cannabis cue Paradigm. Data on craving as well as on impulsive decision making will be collected before and after each treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- •Participants must be between the ages of 18 and
- •Participants must meet DSM-V criteria for Cannabis Use Disorder, with use of at least 20 days/month.
- •Participants must agree to abstinence from Cannabis for at least 24 hours prior to each visit.
- •Participants must have a Positive UDS for cannabis (confirming they are regular users), and a negative salivary cannabis test (Confirming no use within 10-14 hours)
排除标准
- •Participants must not be pregnant and participate in the study.
- •Participants must not test positive for any substance other than cannabis on UDS.
- •Participants must not meet criteria for any other Substance Use Disorders with the exception of Nicotine Use Disorder.
- •Participants must not be on any medications that have central nervous system effects.
- •Participants Must not have a history of/or current Psychotic disorder.
- •Participants must not have a history of Dementia or other cognitive impairment.
- •Participants must not have active suicidal ideation, or suicide attempt within the past 90 days.
- •Participants must not have any contraindications to receiving rTMS as assessed by the TMS safety sheet.
- •Participants must not have any unstable general medical conditions.
研究组 & 干预措施
Active rTMS
Active rTMS will be delivered to the Left DLPFC at 10Hz. A total of 4000 pulses will be delivered.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Sham rTMS
Sham rTMS will be delivered to the Left DLPFC at 10 Hz using an electronic sham system used in multiple other investigations. A total of 4000 pulses of sham rTMS will be delivered.
干预措施: Sham Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Marijuana Craving Questionnaire (MCQ)
时间窗: 15 Minutes
The MCQ will be given before and after a marijuana-cue paradigm, and the primary outcome will be the change score from pre to post.
次要结局
- The Balloon Aptitude Response Task (BART)(30 Minutes)