NCT02126124已完成3 期
A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation (DTMS) (With the H-ADD Coil) Intended as an Aid to Smoking Cessation.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Brainsway
- 入组人数
- 224
- 试验地点
- 30
- 主要终点
- Continuous Quit Rate
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of DTMS compared to sham treatment as an aid to smoking cessation in chronic, heavy (>10 cigarettes/day) cigarette smokers.
详细描述
This is a multi center, randomized, double blind study to evaluate the safety and effectiveness of the device as an aid to smoking cessation. Treatment will be administered over a 6 week period and follow-up assessments will be conducted at 4 months. The clinical study design includes multiple measurements of safety and effectiveness parameters. The design is meant to demonstrate that the device shows superiority compared to sham treatment over six treatment weeks, at the 4 months follow up.
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
- Single (Participant)
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
- 是
入选标准
- •Male or female subjects, 22-70 years old.
- •Chronic, heavy (>10 cigarettes/day) smokers, who smoke for more than 1 year, with no period of abstinence for greater than 3 months during the past year.
- •Subjects who are motivated to quit smoking (with responses "very likely," or "somewhat likely" to the motivation questionnaire).
- •Satisfactory answers on safety screening questionnaire for transcranial magnetic stimulation (Keel 2001).
- •Gave informed consent for participation in the study.
排除标准
- •Currently on Nicotine Replacement Therapy (NRT) or smoking cessation drugs (e.g., Zyban, Chantix, etc.) or undergoing behavioral smoking cessation interventions
- •Cognitive or functional disability, diagnosed according to DSM-IV-TR criteria.
- •Active psychiatric disorder according to DSM IV (Axis I and Axis II) criteria within the last year.
- •Current alcohol or other substance abuse or dependence.
- •Alcohol or other substance abuse or dependence during the last 12 months before recruitment.
- •Subject is smoking any other form of tobacco or other substances.
- •Subject is taking psychotropic medications on a regular basis.
- •Subjects with a high risk for severe violence or suicidality as assessed during the screening interview.
- •Subjects who suffer from an unstable physical disease such as high blood pressure (>150 mmHg systolic / diastolic > 110 mmHg) or acute, unstable cardiac 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 including, but not limited to:
- •Any condition likely to be associated with increased intracranial pressure
- •Space occupying brain lesion
- •History of cerebrovascular accident
- •Transient ischemic attack within two years
- •Cerebral aneurysm
- •Mini Mental State Exam score of less than or equal to 24
- •Parkinson's disease
- •Huntington's chorea
- •Multiple sclerosis
- •Subjects suffering from frequent and severe migraine headaches.
- •Subjects suffering from significant hearing loss.
- •Subjects taking pro-convulsant medications (e.g., antidepressants or 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.
结局指标
主要结局
Continuous Quit Rate
时间窗: 4 week
The primary objective is to compare the four-week continuous quit rate (CQR), representing abstinence during a consecutive 4 week period during the treatment phase, between the two treatment groups.
次要结局
- Number of Cigarettes Smoked Per Day(4 Weeks)
研究者
研究点 (30)
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