Accelerated Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Reduction of Craving in Nicotine Dependent Individuals
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Tolerability Measured by Percent of Participants Completing the rTMS Course
研究概览
简要总结
The purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers. rTMS uses magnetic pulses to stimulate the brain and is currently approved for the treatment of major depressive disorder.
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)
盲法说明
Randomized double blind control using a sham rTMS system
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient Adults aged 18-70
- •Cigarette Smokers smoking at least 1 pack (20 cigarettes a day) with current smoking status confirmed by exhaled CO reading of >10ppm day of visit.
- •Ability to provide informed consent
排除标准
- •Current treatment with varenicline or bupropion
- •Currently making a smoking quit attempt (not currently smoking).
- •Current treatment with an antidepressant, anti-convulsant, anxiolytic, antipsychotic or mood stabilizer.
- •Current episode of major depression determined by MINI interview.
- •Current or past history of schizophrenia, schizoaffective disorder, anorexia nervosa, bulimia or bipolar disorder as determined by MINI.
- •Current daily consumption of alcohol or current alcohol use disorder.
- •Current substance use disorder except for nicotine or cannabis use disorder.
- •Currently pregnant or lactating.
- •Contraindications to rTMS including history of seizure, metal implanted above the neck, pacemaker or any brain lesion.
- •Unstable medical conditions
- •Suicidal ideation or history of suicide attempt within the last six months.
- •Inability or unwillingness of subject or legal guardian/representative to give informed consent
研究组 & 干预措施
Active rTMS
5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
干预措施: Active rTMS with MagVenture MagPro double blind rTMS system (Device)
Sham
5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.
干预措施: Sham rTMS (Device)
结局指标
主要结局
Tolerability Measured by Percent of Participants Completing the rTMS Course
时间窗: 1 day (single visit)
Percent of participants completing the 5 session rTMS course. Hypothesize \>75% of participants will complete the 5 treatments.
Decrease in Cue Induced Nicotine Craving
时间窗: During the one day visit
Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving.
次要结局
- Reduce in Self Reported Smoking(1 week and 2 weeks after rTMS)
研究者
David Friedrich
Resident Physician
Medical University of South Carolina