Smoking Cessation Clinical Trial
Official title:
Personalized Smoking Relapse Prevention Delivered in Real-Time Via Just-in-Time-Adaptive Interventions
Verified date | December 2021 |
Source | Meharry Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 94 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - FDA contraindications for use of NRT: 1. Pregnant 2. Breastfeeding or planning to become pregnant 3. Recent (past 3 months) cardiovascular trauma: MI, stroke - current use (past 30 days) of alternative tobacco products or smoking cessation medications |
Country | Name | City | State |
---|---|---|---|
United States | Meharry Medical College | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Meharry Medical College | Medical University of South Carolina, National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abstinence from cigarettes | Biochemically-verified smoking status (CO<6) obtained at 3-month follow-up | 12 Weeks | |
Secondary | Abstinence from cigarettes | Biochemically-verified smoking status (CO<6) obtained at 1-month follow-up | 4 weeks | |
Secondary | Abstinence from cigarettes | Biochemically-verified smoking status (CO<6) obtained at 1-week follow-up | 1 week |
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