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临床试验/NCT03690596
NCT03690596Unknown不适用

Personalized Smoking Relapse Prevention Delivered in Real-Time Via Just-in-Time-Adaptive Interventions

Meharry Medical College2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年4月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
94
试验地点
2
主要终点
Abstinence from cigarettes

研究概览

简要总结

A small-scale randomized controlled trial (RCT) will pilot test a personalized JITAI designed to guide delivery of fast acting nicotine replacement therapy (NRT; lozenge) in real-time, to prevent smoking relapse. Specifically, a smartphone application (app), will integrate pre-quit smoking data with objective location data captured via global positioning system (GPS) to establish relapse risk (hotspot) algorithms. During a quit attempt, the GPS-enabled app (QuitBuddy) will detect proximity to hotspots and deliver NRT prompts, all of which will occur automatically and prior to exposure. Thus, QuitBuddy will optimize NRT use to prevent cue-provoked cravings known to undermine sustained abstinence, thereby repurposing this evidence-based cessation medication to promote relapse prevention. QuitBuddy will be tested against standard care (NRT with brief instructions). Two versions of QuitBuddy will be tested, which will differ only in how hotspot algorithms are derived: retrospectively from locations recalled at the onset of a quit attempt (QuitBuddy-Recall) or based on real-time EMA completed pre-quit (QuitBuddy).

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

入选标准

  • at least 18 years of age
  • daily cigarette smoker of > 9 cigarettes/day for past year
  • CO breath monitor detects > 10ppm
  • literate in English
  • willing to make a quit attempt in the next week with nicotine replacement therapy
  • no plans to travel outside of a 100-mile radius of Charleston during the study

排除标准

  • FDA contraindications for use of NRT:
  • Breastfeeding or planning to become pregnant
  • Recent (past 3 months) cardiovascular trauma: MI, stroke
  • current use (past 30 days) of alternative tobacco products or smoking cessation medications

结局指标

主要结局

Abstinence from cigarettes

时间窗: 12 Weeks

Biochemically-verified smoking status (CO\<6) obtained at 3-month follow-up

次要结局

  • Abstinence from cigarettes(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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