Brain Substrates of Extinction Based Treatment for Nicotine Dependence
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- To test two quit smoking therapies and to study brain function while each therapy is being used.
研究概览
简要总结
The purpose of this study is to test two quit smoking therapies and to study brain function while each therapy is being used. You will be randomly assigned (like flipping a coin) to one of the two groups. The first therapy is Extinction-Based therapy (EBT). If you are in this group, you will switch to smoking denicotinized cigarettes while wearing a 21 mg/d nicotine patch for one month prior to your quit date. The second therapy is a standard Nicotine Replacement therapy (NRT). If you are in this group, you will smoke your usual brand of cigarettes up to the quit date. Following the quit date, both groups will undergo standard nicotine replacement therapy (21 mg/d for 6 weeks; 14 mg/d for 2 weeks, 7 mg/d for 2 weeks).
In addition to the above, we will recruit a sample of former smokers who are now regular users of e-cigarettes. This group [ECIG] will undergo the same screening and baseline assessments as the EBT and NRT groups up to the completion of fMRI1.
详细描述
If you agree to be in this study, you will be asked to sign the consent form prior to any tests or procedures. You will be asked to come to the laboratory for a screening session. The screening session will take approximately 1.5 hours to complete, including all questionnaires, physical and sample collection. Pregnant or nursing mothers will not be allowed to participate in this study. If you test positive for illegal drug use, you will not be allowed to participate in this study. Depending on the results of the screening procedures you may not be eligible for the study. If you do not have any medical conditions that would make your participation risky, and you feel comfortable participating in the study, you will be given instructions regarding the rest of the study sessions and be asked to return.
Smoker participants who complete the screening visit (described above) and meet all study requirements will then complete 8 lab visits, 1 fMRI training session, 3 fMRI sessions, and 2 follow-up visits. ECIG participants who complete the screening visit and meet all study requirements will complete 1 fMRI training session and 1 fMRI session.
First you will be randomly assigned (like drawing out of a hat) to a study group, either the EBT or NRT group. In the extinction-based therapy (EBT) group, participants will switch to smoking denicotinized cigarettes while wearing a 21 mg/d nicotine patch for one month prior to their quit date; meanwhile, smokers assigned to the nicotine replacement therapy (NRT) group will smoke their usual brand of cigarettes up to the quit date. Following the quit date, both groups will undergo standard nicotine replacement therapy (21 mg/d for 6 weeks; 14 mg/d for 2 weeks, 7 mg/d for 2 weeks).
Eight lab visits (V1 - V8) will be conducted during the 16 weeks following enrollment in the study. These visits will be largely identical, except that instructions and reminders to you about upcoming events will vary from session to session. At each lab visit the following will be collected: vitals (heart rate, blood pressure and weight); breath CO (Carbon Monoxide) and saliva samples for testing smoking and nicotine levels; and measures of smoking withdrawal and mood. You will be given daily diaries to record your smoking behavior and study medication. You will be given instructions on how and when to use all study materials. Advice on quitting and minimal support will be provided as requested at these visits. Each lab visit will require 20-30 minutes of your time.
Directly following V1 you will undergo a training session, during which you will be familiarized with all aspects of the fMRI sessions including tasks and equipment. You will be situated in a scanner simulator, which simulates the sounds and equipment used in the fMRI scanner.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •inability to attend all required experimental sessions,
- •significant health problems (e.g., chronic hypertension (BP>150/90 sitting after 10 minutes), emphysema, seizure disorder, history of significant heart problems),
- •use of psychoactive medications,
- •use of smokeless tobacco,
- •liver or kidney disorder (except kidney stones, gallstones)
- •lung disorder (including but not limited to COPD, emphysema, and asthma)
- •report of coronary heart disease; heart attack; cardiac rhythm disorder (irregular heart rhythm; chest pains; cardiac disorder (including but not limited to valvular heart disease, heart murmur, heart failure)
- •current alcohol or drug abuse,
- •use of illegal drugs as measured by urine drug screen,
- •current use of nicotine replacement therapy or other smoking cessation treatment,
- •presence of conditions that would make MRI unsafe (e.g., pacemaker, metal objects in the body, IUD, orthopedic pins or screws, etc.), or
- •presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies or disorders).
研究组 & 干预措施
1
Extinction Based Group (EBT): switch to smoking denicotinized cigarettes while wearing a 21mg/day nicotine patch for one month prior to their quit date.
干预措施: Nicotine Patches, Denicotinized Cigarettes (Drug)
结局指标
主要结局
To test two quit smoking therapies and to study brain function while each therapy is being used.
时间窗: 14 weeks
次要结局
未报告次要终点