Non-Invasive Deep Brain Neuromodulation for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cigarette per day (CPD)
研究概览
简要总结
This study will develop novel low intensity focused ultrasound (LIFU) therapy to help people to quit cigarette smoking. Smoking is associated with cancers of the lung. Available smoking cessation methods help many to quit. However, for the many who continue to smoke despite the strong desire to quit and after exhausting existing therapeutic approaches, new treatment methods are needed. Without more effective treatment, many will continue to smoke, and our progress on cancer prevention through smoking cessation may decelerate as these associated cancer risks will remain. Brain imaging research has identified specific areas of the brain linked to severe nicotine addiction, but up to now there are no effective ways to directly target most of these deeper brain regions. LIFU is a new and safe method to modulate brain functions that can either inhibit overactive activity or restore normal activity levels. The purpose of this study is to provide a novel ultrasound-based neuromodulation strategy for smoking cessation in people who have difficulty to quit smoking despite numerous serious attempts in their lives. LIFU works by sending acoustic pressure modulating neural activity in the human brain.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be a smoker for 5 or more years and within 20 to 60 years of age
- •Must not meet
排除标准
- •for MRI scanning (e.g., non-fixed magnetizable objects)
- •Must not have ongoing unstable medical, neurological or psychiatric illness as determined by a combination of history, medical record, and/or examination.
- •Must be a current smoker with average of 5 cigarettes or more a day for the last month or longer.
- •Report 3 or more trials of smoking cessation attempts using nicotine replacement, e-cig, TMS, varenicline or other smoking cessation drugs, psychotherapy or other means.
- •Exclusion Criteria:
- •Failed TMS screening questionnaire.
- •Significant alcohol or other drug use (substance dependence within the recent months) or positive urine toxicology screen for substance not prescribed other than nicotine or marijuana dependence.
- •Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
- •Taking > 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose.
- •Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in the last 4 weeks.
- •In ongoing smoking cessation treatment, clinical trial, or nicotine replacements (except for the current study)
研究组 & 干预措施
Active low intensity focused ultrasound (LIFU)
Participants in this group will receive active LIFU treatment
干预措施: Low intensity focused ultrasound with active stimulations (Device)
Sham LIFU
Participants in this group will receive sham LIFU treatment
干预措施: low intensity focused ultrasound with sham stimulations (Device)
结局指标
主要结局
Cigarette per day (CPD)
时间窗: Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline).
Cigarette per day (CPD) is measured to index smoking reduction and cessation.
Brain connectivity as indicated by resting state functional connectivity (rsFC) value as assessed by functional magnetic resonance imaging (fMRI)
时间窗: session 1 (about 1-2 days after baseline) and session 8 (about 4 weeks after baseline).
The strength of rsFC from fMRI is used to represent the brain activities that are corresponding to the transcranial magnetic stimulation (TMS) effect on smoking reduction/cessation.
次要结局
- End-expired carbon monoxide (CO)(Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline).)
- Urinary cotinine level(Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline).)
- Quit rate (%)(Session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline).)
研究者
Xiaoming Du
Assistant Professor
The University of Texas Health Science Center, Houston