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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03690596
Other study ID # 00061239
Secondary ID K23DA041616
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 16, 2019
Est. completion date January 31, 2022

Study information

Verified date December 2021
Source Meharry Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
NRT + QuitBuddy
QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge
NRT + QuitBuddy-Recall
QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge
Treatment as Usual
1 month supply of 4 mg nicotine lozenge

Locations

Country Name City State
United States Meharry Medical College Nashville Tennessee

Sponsors (3)

Lead Sponsor Collaborator
Meharry Medical College Medical University of South Carolina, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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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