Deep rTMS and Varenicline for Smoking Cessation: A Pilot Study Exploring the Efficacy of a Combined Treatment Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Point Prevalence Abstinence at the End of 12 Weeks
研究概览
简要总结
The purpose of this study is to investigate the effect of deep repetitive transcranial magnetic stimulation (rTMS) using the insula H-coil on smoking outcomes in smokers receiving varenicline. It is hypothesized that active deep rTMS will improve abstinence rates, attenuate craving and reduce cigarette consumption and dependence severity.
详细描述
This study will be a randomized, double-blind, sham-controlled clinical trial. Nicotine dependent participants will be recruited and randomized tor receive either active or sham rTMS intervention for 4 weeks (5 sessions/week). All participants will receive an open-label treatment of varenicline for 12 weeks and weekly counselling sessions. The aims of the study are:
- To examine the efficacy of bilateral deep rTMS to the insula on point prevalence smoking abstinence in smokers receiving varenicline treatment.
- To examine the efficacy of bilateral deep rTMS to the insula on other smoking outcomes such as craving, cigarette smoking and dependence severity.
- To examine the effect of bilateral deep rTMS to the insula on abstinence at the end of rTMS treatment and at 6-month follow up.
Abstinence will be measured by point prevalence at week 4 and 12 and prolonged continuous abstinence at week 26. This will be confirmed using plasma cotinine levels. All other measures will be done using various questionnaires such as Fagerstrom Test of Nicotine Dependence (FTND), Timeline Follow-Back (TLFB), Minnesota Nicotine Withdrawal Scale (MNWS), and Tiffany Questionnaire of Smoking Urges (T-QSU).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65;
- •Nicotine dependent as assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
- •Reported daily cigarette consumption ≥ 10 and expired carbon monoxide (CO) measurement of ≥ 10 ppm;
- •Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
- •Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7.
排除标准
- •Reported smoking abstinence in the 3 months preceding screening visit;
- •Current use of other smoking cessation aids;
- •Allergy and/or contraindication to varenicline or rTMS;
- •Pregnancy, trying to become pregnant or breastfeeding;
- •Current or recent history of cardiovascular or cerebrovascular disease and/or current hypertension;
- •Current or historical evidence of suicidal behavior;
- •Serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.);
- •Current, personal history or family history of seizures;
- •Cognitive impairment as defined as a Mini Mental State Examination (MMSE) score <24;
- •Concomitant use of medication that lowers seizure threshold
研究组 & 干预措施
Deep rTMS active + Varenicline
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
干预措施: Deep Repetitive Transcranial Magnetic Stimulation (Active) (Device)
Deep rTMS active + Varenicline
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
干预措施: Varenicline (Drug)
Deep rTMS sham + Varenicline
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
干预措施: Deep Repetitive Transcranial Magnetic Stimulation (Sham) (Device)
Deep rTMS sham + Varenicline
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
干预措施: Varenicline (Drug)
结局指标
主要结局
Point Prevalence Abstinence at the End of 12 Weeks
时间窗: 12 weeks
Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.
次要结局
- Fagerstrom Test For Nicotine Dependence (FTND) Score(26 weeks)
- Expired CO Measurements(26 weeks)
- Cigarettes Per Day (TLFB)(26 weeks)
- Minnesota Nicotine Withdrawal Scale (MNWS) Score(26 weeks)
- Tiffany Questionnaire for Smoking Urges (T-QSU) Score(26 weeks)
- Point Prevalence Abstinence at the End of 4 Weeks(4 weeks)
- Prolonged Abstinence From End of Treatment (Week 12) to End of Follow up (Week 26)(26 weeks)
- Prolonged Abstinence With 2-week Grace Period at End of Follow up (Week 26)(26 weeks)
- Continuous Abstinence at 6 Months(26 weeks)
研究者
Bernard Le Foll
Head,Translational Addiction Research Laboratory
Centre for Addiction and Mental Health