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Contingency Management to Promote Smoking Cessation: A Pilot Randomized Clinical Trial

2026年6月29日 更新者:University of Kansas Medical Center
Adherence to medication and counseling are strong predictors of smoking cessation success. To provide these two components of care, healthcare providers typically provide people who smoke with prescriptions for cessation medications, and refer them to state-sponsored tobacco quitlines. However, most people who smoke that are referred to quitlines never actually enroll, and those who do enroll participate in very few sessions. Similarly, most people who smoke that receive prescriptions for cessation medications rarely fill or use them, even when they have no co-pay or pre-authorization requirements. To address this problem we will recruit 40 patients for a pilot 2-arm effectiveness trial. We will recruit patients from the University of Kansas Medical Center. Participants will then be randomized either to control or Health Reward. All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline (Control condition). In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM). The use of medication will be tracked using an electronic pill dispenser (Wisepill). All participants will be contacted for follow up 3, 6 and 12 weeks after starting the treatment. Feasibility data will include recruitment and retention rates. Preliminary effectiveness outcomes will include treatment engagement and cessation rates.

研究概览

地位

尚未招聘

条件

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

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

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

    • Kansas
      • Kansas City、Kansas、美国、66103
        • University of Kansas Medical Center
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:CounsCM+MedCM
Mobile Contingency management for counseling attendance (CounsCM) and medication intake (MedCM)
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).
有源比较器:Control
12 weeks of varenicline and referral to state quitline
All participants in the control group will receive 12 weeks of varenicline and referrals to their state tobacco quitline.

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
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
第 12 周
Feasibility outcomes
大体时间:Week 3 to 12
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.
Week 3 to 12
Proportion of quitline calls completed
大体时间:Week 12
Completion of the five quitline calls according to Kansas quitline reports
Week 12

次要结果测量

结果测量
措施说明
大体时间
经生化验证戒烟的患者比例
大体时间:第 12 周
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
第 12 周
自我报告戒烟的患者比例
大体时间:第 12 周
过去 7 天自我报告的戒烟情况
第 12 周

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月20日

初级完成 (估计的)

2027年5月30日

研究完成 (估计的)

2027年5月30日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • DA055779-2

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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