Regulation of Craving: Brief Neurocognitive Training and Neural Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Change in Self-report Craving level
研究概览
简要总结
The investigators propose that brief training in regulation of craving may increase the efficacy of smoking cessation, but that training in cognitive vs. mindfulness-based strategies may operate via different psychological and neural mechanisms.
详细描述
The investigators propose to test the efficacy of such training by randomizing 126 cigarette smokers to the following conditions: 1) brief training in cognitive regulation of craving 2) mindfulness-based training, and 3) control or no training. Training will be delivered in 6x1 hour computerized sessions over four weeks. Control subjects simply fill out assessments during their visits. Participants who were randomized into the cognitive or mindfulness training complete Regulation of Craving (ROC) training sessions of approximately 60-90 minutes. If randomized into the cognitive regulation training, subjects will be trained to use a cognitive strategy that instructs them to think of all the negative outcomes associated with continued cigarette smoking. If randomized into the MBT-based regulation training, subjects will be trained to use a mindfulness strategy that instructs them to notice and accept their feelings of craving without judgment or intent to act upon them. After all training sessions are completed, there is a 4 week and 12 week follow-up. The investigators will evaluate the effects of training on craving and regulation of craving measured by self-report and functional magnetic resonance imaging during the Regulation of Craving(ROC) task administered pre- and post- treatment, as well as smoking.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 60
- •Smoking 10 or more cigarettes per day,
- •Score >4 on the Fagerstrom Test For Nicotine Dependence (FTND)
- •Treatment seeking (motivated to quit or reduce smoking; >6 on a 10 point likert scale)
- •Fluent English speaker
- •Can commit to the full length of the protocol (~8 weeks) and
- •Are willing to be randomized to treatment condition.
排除标准
- •Current or past comorbid Axis I disorders (assessed via the Mini Psychiatric Interview Diagnosis; MINI)
- •Current use of any psychoactive medications that have not been at a stable dose for the past 6 months, are used as mood stabilizers, or are used as smoking cessation treatments (e.g. varenicline).
- •Serious or unstable medical condition within past 6 months
- •Use of an investigational drug currently or within past 30 days
- •Use of psychoactive medications or those that affect blood flow
- •Other conditions contra-indicated for MRI (e.g., claustrophobia, presence of ferromagnetic metal in the body, prior head trauma with loss of consciousness, color blindness, hypertension, pregnancy).
- •For females only: pregnancy.
结局指标
主要结局
Change in Self-report Craving level
时间窗: Baseline to 4 weeks
ROC task performance, as change from pre- to post- training in (1) craving (operationalized as self-reported craving on craving trials). (2) strategy-specific regulation (operationalized as scores on regulation trials using the trained strategy: LATER/control trials for CBT-based training, ACCEPT/mindfulness trials for MBT-based training). (3) strategy-non-specific regulation (scores on regulation - using the non-trained strategy: LATER trials for MBT-based training, ACCEPT trials for CBT-based training).
% change in craving and control related neural activity measured via functional magnetic resonance imaging (fMRI).
时间窗: Baseline to 4 weeks
The neural activity component will be calculated as change from pre-to post- training during fMRI ROC task, including (1) craving- related activity (operationalized as neural reactivity in "craving regions" including Ventral Striatum, ventral medial Pre-Frontal Cortex); (2) neural substrates of control during regulation of craving (operationalized as neural activity in "control regions" including dorsal lateral and ventral lateral prefrontal cortex).
Change in Smoking
时间窗: baseline to 4 weeks
Measurement of reduction in cigarette smoking, measured by self report/cotinine/Carbon dioxide(CO2), and FTND smoking severity
次要结局
- Change in Cognitive Control & Affective Reactivity Behavioral Assessments(baseline to 4 weeks)
- Change in general neural activity measured via fMRI(Baseline to 4 weeks)