Skip to content

Smoking Relapse Prevention Via Just-in-Time-Adaptive Interventions

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03690596
Enrollment
94
Registered
2018-10-01
Start date
2019-04-16
Completion date
2022-01-31
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Brief summary

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).

Interventions

OTHERNRT + QuitBuddy

QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge

OTHERNRT + QuitBuddy-Recall

QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge

OTHERTreatment as Usual

1 month supply of 4 mg nicotine lozenge

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Medical University of South Carolina
CollaboratorOTHER
Meharry Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Abstinence from cigarettes12 WeeksBiochemically-verified smoking status (CO\<6) obtained at 3-month follow-up

Secondary

MeasureTime frameDescription
Abstinence from cigarettes4 weeksBiochemically-verified smoking status (CO\<6) obtained at 1-month follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026