Personalized Smoking Relapse Prevention Delivered in Real-Time Via Just-in-Time-Adaptive Interventions
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
NRT + QuitBuddy
This smartphone app will identify high-risk situations through real-time EMA data collected before and during a quit attempt. One week of pre-quit smoking behaviors will be integrated with passively sensed GPS data to create hotspot maps. Hotspot maps will provide interactive visualizations of relapse risk. GPS triggered NRT/behavioral prompts will occur when participants come within 50m from the centroid of a hotspot.
干预措施: NRT + QuitBuddy (Other)
NRT + QuitBuddy-Recall
This smartphone app will identify high-risk situations through retrospective recall of locations where the patient typically smoked. Hotspot maps will provide interactive visualizations of relapse risk. GPS triggered NRT/behavioral prompts will occur when participants come within 50m from the centroid of a hotspot.
干预措施: NRT + QuitBuddy-Recall (Other)
NRT Control (treatment as usual)
Standard Care Control is intended to approximate the real-world experience where smokers obtain over-the-counter NRT and, after brief instructions at the outset (~1 lozenge per hour, during cravings, and <20 per day), determine usage for themselves.
干预措施: Treatment as Usual (Other)
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)
- Abstinence from cigarettes(4 weeks)