Contingency Management to Promote Smoking Cessation: A Pilot Randomized Clinical Trial
研究概览
详细说明
Novel approaches are needed to engage people who smoke in treatment in a way that increases their odds of quitting. Contingency management (CM) interventions provide financial incentives to participants contingent on objective evidence of behavior change and are effective in enhancing medication adherence and treatment engagement for numerous health conditions, including tobacco dependence treatment. Critical gaps, however, remain in our knowledge regarding how best to deploy CM.
The goal of this study is to evaluate the acceptability and feasibility of combined CM for engaging patients in smoking cessation treatment. Participants (N=20) will receive "CounsCM" for engaging in five quitline calls and "MedCM" for utilizing varenicline over twelve weeks. CM payments will be automated and dispensed on a daily basis using a reloadable debit card. The investigators will use surveys and structured interviews to understand strengths, weaknesses, and areas for improvement.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Erica Cruvinel
- 电话号码:913-945-6966
- 邮箱:ecruvinel@kumc.edu
研究联系人备份
- 姓名:Vinita Devarasetty, MPH
- 电话号码:913-617-1018
- 邮箱:v210d808@kumc.edu
学习地点
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Kansas
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Kansas City、Kansas、美国、66103
- University of Kansas Medical Center
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接触:
- Erica Cruvinel
- 电话号码:913-526-0774
- 邮箱:ecruvinel@kumc.edu
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Smoked in the past 30 days
- Smoke at least 1 cigarette per day when they smoke
- ≥ 18 years old
- Kansas resident
- Speak/read English
- Access to a mobile phone
- Mobile phone receives text messages
- No varenicline contraindications (no acute renal impairment)
- Have no significant co-morbidity (i.e., life-threatening illness, communication barriers or altered mental status)
- Cognitively able to participate
- Physically able to participate
- Not pregnant/breastfeeding
Exclusion Criteria:
- Medically ineligible for varenicline
- Patient on smoking cessation medication within 2 weeks of admission date
- Patient already talked to quitline in the past 2 weeks.
- Patients participating in other quit smoking program or research study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:CounsCM+MedCM
Mobile Contingency management for counseling attendance (CounsCM) and medication intake (MedCM)
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All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline.
In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM).
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有源比较器:Control
12 weeks of varenicline and referral to state quitline
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All participants in the control group will receive 12 weeks of varenicline and referrals to their state tobacco quitline.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
服用伐尼克兰药片的比例
大体时间:第 12 周
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根据智能药丸分配器计数,治疗 12 周期间伐尼克兰的摄入量
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第 12 周
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Feasibility outcomes
大体时间:Week 3 to 12
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Feasibility endpoints include: (1) the proportion of eligible subjects who subsequently enroll; and (2) the proportion of enrolled subjects who complete the 3-week, 6-week, and 12-week assessments.
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Week 3 to 12
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Proportion of quitline calls completed
大体时间:Week 12
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Completion of the five quitline calls according to Kansas quitline reports
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Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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经生化验证戒烟的患者比例
大体时间:第 12 周
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使用 ≤ 2 ng/ml 的新木碱标准截断值进行生化确认的 7 天点流行率戒断
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第 12 周
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自我报告戒烟的患者比例
大体时间:第 12 周
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过去 7 天自我报告的戒烟情况
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第 12 周
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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