A Prospective, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of the Use of Deep Transcranial Magnetic Stimulation (dTMS) on Smoking Cessation.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Decrease on Monoximetry level
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of dTMS used as a tool for the smoking cessation; therefore, the subjects will be randomized to be treated on the active group or to receive placebo stimulation.
详细描述
Smoking is the leading cause of preventable deaths in the world. Tobacco use causes more than 5 million deaths per year worldwide.
Among interventions methods that have been found to be effective, the medications are the most promising, using drugs such as Varenicline and Bupropion. Nicotine replacement therapy (NRT) shows results in combination to these drugs.
Alternative approaches to smoking cessation such as acupuncture, hypnosis, smokeless tobacco, electronic cigarettes are not legitimated smoking cessation tools; given that scientific studies showed no difference between these methods and placebo, or yet no rigorous peer-reviewed studies have been conducted.
On the neuromodulation field, Repetitive Transcranial Magnetic Stimulation (rTMS) appears as a new possibility to treat this serious condition.
The rTMS is a non-invasive method of stimulating cortical neurons. Repetitive TMS has been tested as a treatment of various neuropsychiatric disorders associated with cortical excitability disfunctions.
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)
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current heavy (> 10 cigarettes / day) and chronic smokers (who have smoked for more than 1 year, with no abstinence greater than 3 months during the past year);
- •Motivated to quit smoking;
- •Capable to receive TMS treatment (satisfactory answers at the Safety Questionnaire for Transcranial Magnetic Stimulation);
- •Consent report signed by the study participant.
排除标准
- •Using nicotine replacement therapy or drugs to aid in smoking cessation (eg Bup, etc.) or dealing with behavioral therapy for smoking cessation.
- •Functional or cognitive disorder, diagnosis according to DSM-
- •Psychiatric Disorder active in the last year, according to DSM-5 (Axis I). Exception to depressive and anxious disorders, provided that in a stable condition.
- •Substance or drug abuse or dependency in the current or in the last year prior to selection.
- •Subjects who smoke any other type of tobacco or substances.
- •Subjects with a high risk of violence or suicide assessed during the interview.
- •Subjects suffering from any physical instability such as high blood pressure (> 150 mmHg systolic / diastolic> 110 mmHg) or acute or unstable heart disease.
- •History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).
- •Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head injury or trauma with loss of consciousness for > 5 minutes.
- •History of any metal in the head (outside the mouth).
- •Metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
- •Individuals with a significant neurological disorder or insult;
- •Subjects suffering from frequent and severe migraine headaches.
- •Subjects suffering from significant hearing loss.
- •Subjects taking pro-convulsant medications (e.g., antipsychotic medications).
- •Previous treatment with TMS.
- •Subjects who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the experiment.
- •Participation in a clinical trial within the last 30 days before the beginning of this clinical trial or similar participation in another clinical trial.
- •Known or suspected pregnancy or lactation.
- •Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
研究组 & 干预措施
dTMS active
patients undergoing of dTMS real
干预措施: Deep Transcranial Magnetic Stimulation (Device)
dTMS Sham
patients undergoing to placebo dTMS
干预措施: Deep Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Decrease on Monoximetry level
时间窗: before each session at phase 1 (6 weeks = sessions from 1 to 18)
The researchers will perform the measurement of the rate of expired carbon monoxide through a monoximeter.
次要结局
- Changes on Cotinine blood level(at session 1 and after session 18 (6 weeks))
研究者
Manoel Jacobsen Teixeira
Professor
University of Sao Paulo General Hospital