Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement: A Randomized, Controlled Pilot Study in Motivated Smokers Unable to Quit With Standard Dosing
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 4 weeks continuous smoking abstinence
研究概览
简要总结
This study involves the use of personalized nicotine patch dosing as a treatment strategy for smokers who cannot quit smoking after 2 weeks of using the standard nicotine patch dose. Functional Magnetic Resonance Imaging scans will also be obtained from all study participants before and after treatment. The first aim of the study is to determine if the treatment method under investigation is safe and more effective at increasing quit rates in smokers who do not respond to standard therapy.The second aim is to determine if there are any treatment- or cessation-related changes in brain function.
详细描述
Nicotine Replacement Therapy (NRT) is limited in efficacy. One possible explanation for this limited efficacy is that the nicotine dose received in standard therapy is not enough to replace the amount of nicotine that smokers typically receive from their cigarettes. In an effort to counteract this problem, this study will increase the nicotine patch dose of smokers until they no longer feel the need to keep smoking or they cannot tolerate a higher nicotine dose. Smokers who cannot quit using 21 mg nicotine patch for 2 weeks will be randomized to either the experimental arm of the study where nicotine patch doses will be adjusted according to individual need or the positive control arm where standard NRT smoking cessation therapy will be employed. The primary outcome measure will be continuous abstinence during the last 4 weeks of treatment. In addition, participants will be assessed to see how treatment has impacted their resting state neural activity as well as their responsiveness to smoking and emotional cues. Follow up sessions will be used to assess long term abstinence as well as long term change in neural activation.
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
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Daily tobacco smoker of
- •Aged 19 to 65 years old
- •Intending to quit smoking within the next 30 days
- •Interested in using transdermal nicotine replacement therapy (nicotine patch)
排除标准
- •At least weekly use of tobacco products other than cigarettes
- •Breast feeding, pregnancy or not using a reliable form of birth control
- •Any generalized skin disorders precluding the use of the patch
- •Immediate post-myocardial infarction period or life-threatening arrhythmias, severe or worsening angina pectoris or recent cerebral vascular accident
- •Any clinically significant electrocardiogram (ECG) abnormalities
- •Currently using NRT or other smoking cessation pharmacotherapy
- •Any known hypersensitivity or allergies to any of the components comprising the nicotine patch
- •MRI contraindications (e.g., metal in body, claustrophobia) as per the CAMH RIC screening questionnaire
- •Diagnosis of terminal illness.
研究组 & 干预措施
Experimental Arm
Escalating nicotine patch dose to satiety over 6 weeks with dosage depending on the number of cigarettes smoked per day and the occurrence of adverse effects
干预措施: Nicotine patch (Drug)
Positive Control Arm
Nicotine patch dose of 21mg coupled with nicotine mouthspray which is to be used as needed.
干预措施: Nicotine patch (Drug)
Positive Control Arm
Nicotine patch dose of 21mg coupled with nicotine mouthspray which is to be used as needed.
干预措施: Nicotine mouthspray (Drug)
结局指标
主要结局
4 weeks continuous smoking abstinence
时间窗: Treatment weeks 9-12 inclusive
4 weeks of abstinence without a single puff of a cigarette confirmed by self-report and exhaled carbon monoxide (CO less than or equal to 4ppm)
次要结局
- Cue induced brain activation(up to 6 month follow-up)
研究者
Laurie Zawertailo
Clinical Scientist
Centre for Addiction and Mental Health