Approach Bias Retraining for Nicotine Addiction Among Dual Combustible and Electronic Cigarette Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Biochemically-Verified Point Prevalence Abstinence
研究概览
简要总结
The present project will evaluate the initial efficacy of approach bias retraining among dual combustible cigarette (CC) and electronic cigarette (ECIG) users. The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining.
详细描述
The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining. Participants will be randomized to one of three approach bias retraining conditions: (1) CC+ECIG; (2) CC only; or (3) sham (control). Participants will complete a phone pre-screener, baseline (week 1 of study participation), 4 approach bias retraining sessions in laboratory (with quit day scheduled for the 4th session; weeks 2-5 of study participation), and follow-up assessments at 4- and 6-weeks post-intervention (i.e., weeks 9 and 11 of study participation, respectfully). Participants also will complete ecological momentary assessments (EMA) of CC smoking, ECIG use, and CC and ECIG urges/cravings for 14 days post-intervention (i.e., weeks 5-7 of study participation) on Internet capable smartphones. The only time data will be collected is when participants complete EMA assessments or follow up surveys using the REDCap app on the smartphone.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •At least 15 days of CC use for the previous month
- •ECIG use with nicotine at least 15 days for the previous month
- •Motivation to quit nicotine (BOTH CC and ECIG; ≥ 5 on a 0-10 scale)
- •Ability to speak and read English fluently
- •Not have decreased number of cigarettes by more than half in the past month
- •Own an android smartphone (for EMA).
排除标准
- •Current psychotherapy or pharmacotherapy for mental illness or addiction
- •Current use of nicotine replacement therapy, Zyban, or Chantix
- •Limited mental capacity or inability to provide informed consent
- •Insufficient command of the English language (>6th grade English literacy level required)
结局指标
主要结局
Biochemically-Verified Point Prevalence Abstinence
时间窗: Week 9 of participation
Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG)
Prolonged Abstinence
时间窗: Week 9 of participation
Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG)
Lapse
时间窗: Week 9 of participation
Time to first use (CC and/or ECIG)
Nicotine Relapse
时间窗: Week 9 of participation
7th day on which CC or ECIG occurs
次要结局
- Prolonged Abstinence(Week 11 of participation)
- Lapse(Week 11 of participation)
- Questionnaire of Vaping Craving(Week 1-7, 9, and 11 of participation)
- Questionnaire of Smoking Urges-Brief (QSU-Brief)(Week 1-7, 9, and 11 of participation)
- Approach Bias(Weeks 2-5 of participation)
- Biochemically-Verified Point Prevalence Abstinence(Week 11 of participation)
- Nicotine Relapse(Week 11 of participation)
研究者
Lorra Garey
Assistant Research Professor
University of Houston