Evaluation of the Efficacy of Low-frequency rTMS on Craving in Smoking Dependence: Single-centre Randomized, Controlled Blinded Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change from Baseline score of Tabacco Craving Questionnaire (TCQ)
研究概览
简要总结
The fight against smoking is a public health priority. Without help, fewer than 5% of des smokers are abstinent at 12 months after smoking cessation.
Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of success at 12 months in patients dependent on nicotine is only 18%. Moreover, other therapeutic strategies (acupuncture, hypnosis…) have not proved to be effective.
The investigators propose a new therapeutic strategy for smoking cessation, which is based on associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine) with rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to diminish craving for tobacco). The principal objective is to improve the success rate for smoking cessation attempts in patients who are highly dependent on nicotine, and who have failed using usual smoking cessation strategies.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18-65 years old
- •Wishing to stop smoking
- •Highly dependent on nicotine (score ≥ 7 on the Fagerström self-questionnaire)
- •History of at least 2 failed attempts to stop smoking despite recommended treatments (nicotine, vareniciline, bupropion)
排除标准
- •Abstinence in the 3 previous months
- •Absence of effective contraception for women
- •Progressive chronic disease
- •Ongoing psychiatric disorders
- •Current addiction to other substances or cessation of less than one year
- •Current treatment with psychotropic agents
- •Epilepsy and other contra-indications for rTMS (pacemaker, metallic clips or other electronic implants, head trauma, intracranial hypertension).
- •Contra-indications for transdermal nicotine substitutes (recent myocardial infarction, unstable or worsening angina, Prinzmetal angina, severe heart rhythm disorders, recent stroke, skin disorders that could interfere with the use of transdermal treatments, hypersensitivity to one of the constituents).
- •Personnel working in the psychiatric and addictology unit of the CHU (conflict of interest)
研究组 & 干预措施
active rTMS
干预措施: active rTMS (Device)
placebo rTMS
干预措施: sham rTMS (Device)
结局指标
主要结局
Change from Baseline score of Tabacco Craving Questionnaire (TCQ)
时间窗: at Week 0, Week 1, Week 2, Week 6 and Week 12 after stimulation
次要结局
未报告次要终点