The QUIT Smoking Study: A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care to Help Homeless Smokers Quit Smoking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
研究概览
简要总结
The QUIT (Quitting with Usual Care, Incentives, and Technology) Smoking Study is a 3-arm pilot randomized controlled trial that will test the effect of 2 different experimental smoking cessation interventions relative to a control condition in homeless cigarette smokers. All participants will receive free transdermal nicotine patches and weekly in-person smoking cessation counseling. In addition, participants randomized to the first experimental condition will receive financial rewards for biochemically-verified smoking abstinence, and participants randomized to the second experimental condition will be enrolled in a text messaging program to support smoking abstinence.
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
- 否
入选标准
- •Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers.
- •Age ≥18 years old, assessed by self-report and verified by date of birth.
- •Has smoked ≥100 cigarettes and currently smokes ≥5 cigarettes per day, verified by an exhaled carbon monoxide level of ≥8 ppm.
- •Ready to try quitting smoking within the next month.
- •Currently homeless, assessed by self-report and defined as usually staying in an emergency shelter, transitional shelter, abandoned building, place of business, car or other vehicle, church or mission, hotel or motel, or anywhere outside during the past 7 days. Additionally, individuals will be considered currently homeless if they usually stayed in somebody else's house, apartment/condominium, or room in the past 7 days because of not having their own place to stay.
排除标准
- •Currently pregnant, assessed by a urine pregnancy test conducted on all premenopausal biologic females who have not had a hysterectomy, or planning to become pregnant in the next 2 months.
- •Past 30-day use of nicotine replacement therapy, bupropion, or varenicline for smoking cessation, assessed by self-report. Use of bupropion for reasons other than to quit smoking (e.g. depression) is permissible.
- •Prior serious adverse reaction to the nicotine patch, defined as any reaction that was life-threatening or required hospitalization.
- •Heart attack or chest pain within the past 2 weeks.
- •Inability to read a sentence written at a Flesch-Kincaid grade level of
- •Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate.
研究组 & 干预措施
Control (N=25)
- Transdermal nicotine patch
- In-person smoking cessation counseling
干预措施: Transdermal nicotine patch (Drug)
Control (N=25)
- Transdermal nicotine patch
- In-person smoking cessation counseling
干预措施: In-person smoking cessation counseling (Behavioral)
Financial rewards (N=25)
- Transdermal nicotine patch
- In-person smoking cessation counseling
- Contingent financial rewards for smoking abstinence
干预措施: Transdermal nicotine patch (Drug)
Financial rewards (N=25)
- Transdermal nicotine patch
- In-person smoking cessation counseling
- Contingent financial rewards for smoking abstinence
干预措施: In-person smoking cessation counseling (Behavioral)
Financial rewards (N=25)
- Transdermal nicotine patch
- In-person smoking cessation counseling
- Contingent financial rewards for smoking abstinence
干预措施: Contingent financial rewards for smoking abstinence (Behavioral)
Text messaging (N=25)
- Transdermal nicotine patch
- In-person smoking cessation counseling
- Text messages to support smoking abstinence
干预措施: Transdermal nicotine patch (Drug)
Text messaging (N=25)
- Transdermal nicotine patch
- In-person smoking cessation counseling
- Text messages to support smoking abstinence
干预措施: In-person smoking cessation counseling (Behavioral)
Text messaging (N=25)
- Transdermal nicotine patch
- In-person smoking cessation counseling
- Text messages to support smoking abstinence
干预措施: Text messages to support smoking abstinence (Behavioral)
结局指标
主要结局
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
时间窗: Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period
The primary outcome is a repeated-measures assessment of smoking abstinence, defined as an exhaled carbon monoxide \<8ppm and assessed 14 times over the 8-week study period (3 times/week for the first 2 weeks, 2 times/week for the next 2 weeks, and once every week for the last 4 weeks)
次要结局
- Counseling Visit Attendance(8 weeks)
- Percentage of Visits Abstinent of Smoking(8 weeks)
- Change in Behavioral Health(4 weeks and 8 weeks)
- Smoking Abstinence at End of Study(8 weeks)
- Study Visit Attendance(8 weeks)
- Nicotine Patch Use(8 weeks)
- Change in Cigarette Consumption(Once per week for 8 weeks)
研究者
Travis Paul Baggett
Assistant Professor of Medicine
Massachusetts General Hospital