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临床试验/NCT06456242
NCT06456242已完成不适用

Contingency Management to Promote Smoking Cessation

University of Kansas Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Proportion of quitline calls completed

研究概览

简要总结

Many hospitals and outpatient clinics often refer people who smoke to quitlines and provide prescriptions for smoking cessation medications, but patients rarely fully engage in counseling or use their cessation medications. This is a single-arm, open-label pilot study to provide feasibility metrics for a text-based contingency management (CM) intervention to increase engagement in smoking cessation treatment. All participants (N=20) will be referred to a state quitline and will receive a prescription for medication plus 12 weeks of a text-based CM intervention to increase engagement in quitline calls and varenicline utilization. The engagement of participants in quitline counseling will be tracked for 6 weeks and medication utilization for 12 weeks post-enrollment. The investigators will use mixed-methods to collect implementation and acceptability data to inform changes to the text-based contingency management (CM) intervention.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • 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)
  • Insurance coverage for varenicline
  • 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

排除标准

  • 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

研究组 & 干预措施

MedCM plus CounsCM

Experimental

Mobile Contingency Management for counseling attendance and medication intake

干预措施: CounsCM+MedCM (Health Rewards) (Behavioral)

结局指标

主要结局

Proportion of quitline calls completed

时间窗: Week 6

Completion of the five quitline calls over 6 weeks of treatment according to Kansas quitline reports

Proportion of varenicline pills taken

时间窗: Week 12

Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting

次要结局

  • Proportion of self-reported varenicline pills taken(Week 3)
  • Proportion of patients with biochemically verified smoking abstinence(Week 12)
  • Proportion of patients with self-reported smoking abstinence(Week 12)
  • Proportion of patients adherent to varenicline(Week 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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