A Puff Topography Biofeedback Paradigm to Reduce Stress-Precipitated Smoking Reinforcement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Cigarette Purchase Task- Omax
研究概览
简要总结
The purpose of the study is to examine the effects of a novel bio-behavioral paradigm, entitled, Puff Topography Biofeedback Training, compared to a control condition, in reducing stress-induced smoking reinforcement.
详细描述
Smokers with emotional distress are particularly vulnerable to smoking reinforcement due to various biopsychological factors that contribute to deficits in emotion regulation and heightened reward processing, which undermine cessation efforts. Differences in puffing behavior may correspond with changes in cardiorespiratory parameters that may promote self-regulation and reduce craving.
This study is a between-subjects experimental test of Puff Topography Biofeedback Training (PTBT) and its ability to modify puff topography and cardiorespiratory activity during stress-precipitated smoking, and in turn, reduce acute smoking reinforcement.
Participants will be randomized to either PTBT or a Control condition and will complete two smoking trials on two successive days. The first smoking trial (Visit 1) will allow participants to gain familiarity with the task. The second smoking trial (Visit 2) will be completed following acute laboratory stress induction (stress-precipitated smoking trial).
The primary study aims are to test the effect of PTBT vs. Control as assessed via acute changes in stress-precipitated smoking reinforcement and changes in puffing behavior and cardiorespiratory parameters.The results of this high pre-intervention study could inform the subsequent development of a novel intervention strategy for improving quit outcomes in a treatment-resistant population.
The primary study aims are to test the effect of PTBT vs. Control in terms of: (a) objective puff topography parameters; (b) subjective reinforcement; and (c) whether physiological indices reflective of smoking reinforcement differ between conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55
- •Daily smoking ≥ 8 cigarettes/day verified by carbon monoxide analysis of breath sample ≥ 8 ppm
- •Smoking within 30 minutes of waking
- •English fluency.
排除标准
- •Current smoking cessation treatment
- •Past-month reduction of cigarettes/day by ≥50%
- •Moderate or severe non-nicotine substance use disorder
- •Past-year psychiatric instability (e.g., psychosis, mania)
- •Severe visual, hearing, or cognitive impairments
- •Medical condition that could impact stress reactivity or physiology
- •Current regular use of medication that could affect cardiorespiratory function (e.g., beta blockers, benzodiazepines; note-use of SSRIs/SNRIs is permitted if dose is stable ≥ 6 wks).
结局指标
主要结局
Cigarette Purchase Task- Omax
时间窗: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the Omax, which is the number of cigarettes the individual endorses that they would purchase at the peak expenditure for a cigarette (i.e., highest endorsed US dollar per cigarette cost; Pmax).
Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale
时间窗: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.
The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes liking, or cigarette satisfaction. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective smoking satisfaction. Scores on the mCEQ cigarette satisfaction subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.
Cigarette Purchase Task - Intensity
时间窗: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is intensity, which is the number of cigarettes consumed at zero cost.
Cigarette Purchase Task- Pmax
时间窗: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the Pmax, which is the price at maximum expenditure for a cigarette.
Cigarette Purchase Task- Breakpoint
时间窗: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the breakpoint, which is the cost whereby consumption is suppressed to zero.
Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale
时间窗: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.
The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes wanting, or cigarette craving reduction. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective cigarette craving reduction. Scores on the mCEQ craving reduction subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.
Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale
时间窗: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.
The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes learning, or psychological reward. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective psychological reward. Scores on the mCEQ psychological reward subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.
次要结局
- Changes in Cardiac Vagal Control(Second Training Day prior to Stress-Induction, and following Stress-Induction during Intervention (Smoking Task), average 1 day.)
- Puff Topography(Second Training Day following Stress-Induction during Intervention (Smoking Task), average 1 day.)
研究者
Teresa M. Leyro, Ph.D.
Associate Professor
Rutgers, The State University of New Jersey