A Proof-of-concept Study of Real-time fMRI Neurofeedback Training for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Smoking Lapse Paradigm
研究概览
简要总结
This study will examine how real-time functional magnetic resonance imaging (rt-fMRI) feedback can be used to modulate brain activation in the context of smoking cues in order to resist craving. Participants will complete a total of three fMRI scanning sessions with a cue suppression task with or without neurofeedback training (NFT). Participants will be randomized to an active group (active NFT) or a control group (no NFT) during the scanning sessions. At the end of the third session, all participants will complete a validated smoking lapse laboratory paradigm to evaluate effects of NFT on smoking behavior.
详细描述
Smoking is the greatest preventable cause of mortality and a significant economic burden. Even with the best available treatments, most smokers relapse within days or weeks after a quit attempt. Nicotine replacement therapy, the most widely used pharmacotherapy, yields end of treatment quit rates of <25% suggesting that managing nicotine withdrawal is not sufficient. A smoker's response to smoking cues is one factor that increases risk of relapse. This study will examine how real-time functional magnetic resonance imaging (rt-fMRI) feedback can be used to modulate brain activation in the context of smoking cues in order to resist craving. First, we will conduct a pilot study in 12 smokers for technical development and to evaluate the feasibility of the proposed study procedures. Participants will complete a total of three fMRI scanning sessions with a cue suppression task with or without neurofeedback training (NFT). Participants will be randomized to an active group (active NFT) or a control group (no NFT) during the scanning sessions. At the end of the third session, all participants will complete a validated smoking lapse laboratory paradigm to evaluate effects of NFT on smoking behavior. Upon successful completion of the technical development phase, we will proceed to a proof-of-concept phase, which will recruit 72 smokers to evaluate the efficacy of NFT for smoking behavior.
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)
盲法说明
Treatment-seeking smokers complete an intake session and then be randomized to an active NFT group or a control group.
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
- 是
入选标准
- •Treatment-seeking smokers between the ages of 18 and 65, reporting consumption of at least 10 cigarettes per day for at least the past 6 months;
- •Planning to live in the area for at least the next month;
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
- •Able to communicate fluently in English (speaking, writing, and reading).
排除标准
- •Smoking Behavior:
- •Use of chewing tobacco or snuff or cigars;
- •Current enrollment or plans to enroll in another smoking cessation program or research study in the next month;
- •Current or anticipated (within the next month) use of smoking cessation medications or nicotine replacement therapy (NRT);
- •A baseline carbon monoxide (CO) reading less than 10ppm.
- •Alcohol/Drugs:
- •Current alcohol consumption that exceeds 25 standard drinks/week;
- •Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at intake; a. Participants testing positive for breath alcohol with a reading equal to or greater than .08 (the legal driving limit) or who are visibly impaired will be instructed not to drive themselves home after the appointment. If a participant needs to use a phone to call for a safe ride home, an office telephone will be made available to the participant.
- •Medication:
- •Current use or recent discontinuation (within the past 30 days at the time of Intake) of:
- •Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT);
- •Anti-psychotic medications;
- •Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician;
- •Daily use of:
- •Opiate-containing medications for chronic pain.
- •Medical/Neuropsychiatric:
- •Women who are pregnant, planning a pregnancy, and/or breast feeding. All female subjects of childbearing potential will undergo a urine pregnancy test at Intake and at each scan session.
- •History of epilepsy or a seizure disorder;
- •History of stroke;
- •Self-reported brain (or CNS) or spinal tumor;
- •Self-reported history of head trauma;
- •Self-reported history or current diagnosis of psychosis.
- •fMRI-Related:
- •Self-reported use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for fMRI;
- •Self-reported history of claustrophobia;
- •Being left-handed;
- •Color blindness;
- •Weight greater than 250lbs at intake;
- •Self-reported history of gunshot wounds;
- •Any impairment preventing participants from using the response pad necessary for the computer tasks;
- •Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).
- •General Exclusion:
- •Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator;
- •Enrollment or plans to enroll in another research study;
- •Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
研究组 & 干预措施
Real-time neurofeedback training group
We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In this arm, participants will complete four sessions: an intake session and 3 neurofeedback scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes.
干预措施: Realtime biofeedback using fMRI (Behavioral)
No-feedback control group
We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In the control group arm, participants will complete four sessions: an intake session and 3 scanning visits with no neurofeeback. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes.
结局指标
主要结局
Smoking Lapse Paradigm
时间窗: Study session 3 (scan day 3)
Time (sec) to first cigarette during a 50 minute monitored smoking lapse period in smoking laboratory
次要结局
- Cue induced brain signal change(Study session 3 (scan day 3))