Cessation in Non-Daily Smokers: A RCT of NRT With Ecological Momentary Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 505
- 试验地点
- 1
- 主要终点
- Smoking Cessation, Continuous 6-month Abstinence
研究概览
简要总结
The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA).
详细描述
Our aim is to study the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers (ITS), and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA). This is a double-blind, randomized, placebo-controlled trial of oral NRT for smoking cessation in ITS. 600 ITS who are interested in quitting will be recruited through multiple channels. Enrollees will be randomized 1:1 to active 2 mg nicotine gum or an inert control gum. Participants will attend 6 sessions with brief behavioral support, with a planned quit day at week 2. Short and long term abstinence will be assessed and biochemically validated. EMA data collection includes two weeks of baseline data on ad lib smoking patterns and 6 weeks of post-quit data. This will capture data on craving, withdrawal, and relapse among ITS, and relate relapse contexts to baseline smoking patterns.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Smoking for at least 3 years
- •Smoking non-daily for at least one year (< or = 27 days/month)
- •Smoke at least weekly
- •Intention to quit smoking within the next month and a desire to receive behavioral and medication treatment
- •Willing and able to come to the laboratory for 8 visits over a 14-week period, as well as a ninth and final visit 6 months after their quit date
- •Willing to monitor behavior via an electronic diary for 8 weeks
- •Able to read and write English (in order to understand questionnaires and study instructions)
排除标准
- •Regular use of any form of tobacco other than cigarettes
- •Recent or severe mental illness (uncontrolled severe depression or mood symptoms, active hallucinations, and or hospitalization in the past month for a psychiatric condition)
- •Night and/or 'swing' shift work (which complicates EMA schedules)
- •Known plans to relocate or move from the Pittsburgh area within the coming 6 months
- •Received cessation treatment within past year
- •Use of bupropion or varenicline in past 2 months
- •Past use of nicotine gum (to avoid un-blinding)
- •Contraindication to NRT
- •(for women) Current pregnancy or breastfeeding or plan to become pregnant during the next 2 months
- •Member of the same household already participating
研究组 & 干预措施
Inactive gum
干预措施: Standard behavioral therapy (Behavioral)
Active nicotine gum
干预措施: active nicotine gum (Drug)
Active nicotine gum
干预措施: Standard behavioral therapy (Behavioral)
结局指标
主要结局
Smoking Cessation, Continuous 6-month Abstinence
时间窗: up to week 24
Long term abstinence assessed and biochemically validated. The results reported are the number of participants self-reporting continuous abstinence throughout the 6-month, post-quit follow-up period. To be considered abstinent, a participant must have self-reported having not smoked during this period, demonstrated carbon monoxide levels less than or equal to 3 at each study visit, and cotinine values assessed via urinalysis at levels less than or equal to 25 ng/ml.
次要结局
- Characteristics of Quit and Relapse Process - Negative Affect(Six-week post-quit period)
- Characteristics of Quit and Relapse Process - Saw No Smoking Cues(Six-week post-quit period)
- Characteristics of Quit and Relapse Process - Craving(Six-week post-quit period)
- Characteristics of Quit and Relapse Process - No Others Smoking Nearby(Six-week post-quit period)
研究者
Brian Primack
MD, PhD
University of Pittsburgh