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Machado NM, Ahluwalia JS, Businelle MS, Frank-Pearce SG, Baranskaya I, Hébert ET, Sifat MS, Gwin SH, Thakur R, Glassman S, Kinnard HW, Kumar G, Gupta D, Kendzor DE
A Randomized Factorial Trial of Varenicline, Nicotine Lozenges, and Smartphone Medication Adherence Reminders for Smoking Cessation: Protocol for the COMBO II Study
A Randomized Factorial Trial of Varenicline, Nicotine Lozenges, and a Smartphone Medication Adherence Reminders for Smoking Cessation: Protocol for the COMBO II Study
Nathalia M. Machado;
Jasjit S. Ahluwalia;
Michael S. Businelle;
Summer G. Frank-Pearce;
Irina Baranskaya;
Emily T. Hébert;
Munjireen S. Sifat;
Shannon H. Gwin;
Roma Thakur;
Sharon Glassman;
Henry W. Kinnard;
Gaurav Kumar;
Deeksha Gupta;
Darla E. Kendzor
ABSTRACT
Background:
Smoking remains the leading preventable cause of cancer mortality in the U.S. Varenicline is the most effective monotherapy for smoking cessation and combining it with nicotine replacement therapy (NRT) may further improve cessation rates. Smartphone-based medication adherence interventions could enhance pharmacotherapy adherence and cessation outcomes.
Objective:
This trial will evaluate the efficacy of varenicline plus nicotine lozenges and a smartphone adherence intervention for promoting smoking cessation.
Methods:
This fully remote, 2x2 factorial randomized controlled trial will enroll 496 adults from Oklahoma who smoke cigarettes daily. Participants will be randomized to one of four conditions: 1) varenicline (VAR) + nicotine lozenges (NRT) vs. VAR alone, and 2) a smartphone-based smoking cessation app with (COMBO-A [adherence]) or without adherence components (COMBO-B [basic]). The primary outcome is biochemically verified 7-day point prevalence abstinence at 26 weeks post-quit date. Secondary outcomes include medication adherence, withdrawal symptoms, and medication side effects over the 12-week treatment period.
Results:
This study will assess the impact of medication type (VAR+NRT vs. VAR) and smartphone intervention (COMBO-A vs. COMBO-B) on medication adherence and smoking cessation outcomes. Potential interactions between medication type and smartphone intervention type will also be explored.
Conclusions:
If effective, VAR+NRT would offer a new evidence-based cessation treatment option. If the smartphone adherence intervention improves medication adherence and cessation, it could be adapted for other pharmacotherapies and widely implemented. Ultimately, this research aims to enhance cessation efforts and reduce cancer risk among adults who smoke. Clinical Trial: ClinicalTrials.gov NCT07099638; https://clinicaltrials.gov/study/NCT07099638
Citation
Please cite as:
Machado NM, Ahluwalia JS, Businelle MS, Frank-Pearce SG, Baranskaya I, Hébert ET, Sifat MS, Gwin SH, Thakur R, Glassman S, Kinnard HW, Kumar G, Gupta D, Kendzor DE
A Randomized Factorial Trial of Varenicline, Nicotine Lozenges, and Smartphone Medication Adherence Reminders for Smoking Cessation: Protocol for the COMBO II Study