Varenicline Combined With Oral Nicotine Replacement Therapy and Smartphone-Based Medication Reminders for Smoking Cessation: Feasibility Randomized Controlled Trial

Abstract

Background: Varenicline and oral nicotine replacement therapy (NRT) have each been shown to increase the likelihood of smoking cessation, but their combination has not been studied. In addition, smoking cessation medication adherence is often poor, thus, challenging the ability to evaluate medication efficacy.

Objective: This study examined the effects of combined varenicline and oral NRT and smartphone medication reminders on pharmacotherapy adherence and smoking abstinence among adults enrolled in smoking cessation treatment.

Methods: A 2×2 factorial design was used. Participants (N=34) were randomized to (1) varenicline + oral NRT (VAR+NRT) or varenicline alone (VAR) and (2) smartphone medication reminder messages (REM) or no reminder messages (NREM) over 13 weeks. Participants assigned to VAR+REM received varenicline reminder prompts, and those assigned to VAR+NRT+REM also received reminders to use oral NRT. The other 2 groups (VAR+NREM and VAR+NRT+NREM) did not receive medication reminders. Participants were not blinded to intervention groups. All participants received tobacco cessation counseling. Smartphone assessments of smoking as well as varenicline and NRT use (if applicable) were prompted daily through the first 12 weeks after a scheduled quit date. Descriptive statistics were generated to characterize the relations between medication and reminder group assignments with daily smoking, daily varenicline adherence, and daily quantity of oral NRT used. Participants completed follow-up assessments for 26 weeks after the quit date.

Results: Participants were predominantly White (71%), and half were female (50%). On average, participants were 54.2 (SD 9.4) years of age, they smoked an average of 19.0 (SD 9.0) cigarettes per day and had smoked for 34.6 (SD 12.7) years. Descriptively, participants assigned to VAR+NRT reported more days of smoking abstinence compared to VAR (29.3 vs 26.3 days). Participants assigned to REM reported more days of smoking abstinence than those assigned to NREM (40.5 vs 21.8 days). Participants assigned to REM were adherent to varenicline on more days compared to those assigned to NREM (58.6 vs 40.5 days), and participants assigned to VAR were adherent to varenicline on more days than those assigned to VAR + NRT (50.7 vs 43.3 days). In the subsample of participants assigned to VAR+NRT, participants assigned to REM reported more days where ≥5 pieces of NRT were used than NREM (14.0 vs 7.4 days). Average overall medication adherence (assessed via the Medication Adherence Questionnaire) showed the same pattern as the daily smartphone-based adherence assessments.

Conclusions: Preliminary findings indicated that smoking cessation interventions may benefit from incorporating medication reminders and combining varenicline with oral NRT, though combining medications may be associated with poorer adherence. Further study is warranted.

Trial registration: ClinicalTrials.gov NCT03722966; https://classic.clinicaltrials.gov/ct2/show/NCT03722966.

Keywords: NRT; cessation; controlled trial; mHealth; medication adherence; mobile phone; nicotine; nicotine replacement therapy; quit; quitting; randomized; smartphone-based medication reminders; smoke; smoker; smoking; smoking cessation; varenicline combined with oral nicotine replacement therapy.

Conflict of interest statement

Conflicts of Interest: MSB and DEK are inventors of the Insight mHealth Platform, which was used to develop the study app. They receive royalties related to its use. However, they did not receive royalties in this case. JSA received sponsored funds for travel expenses as a speaker for the 2021 and 2022 annual GTNF conference. JSA serves as a consultant, receives compensation, and has equity in Qnovia, a start-up company developing a prescription nicotine replacement product for FDA approval.

©Munjireen Sifat, Emily T Hébert, Jasjit S Ahluwalia, Michael S Businelle, Joseph J C Waring, Summer G Frank-Pearce, Chase Bryer, Lizbeth Benson, Stefani Madison, Lourdes G Planas, Irina Baranskaya, Darla E Kendzor. Originally published in JMIR Formative Research (https://formative.jmir.org), 27.10.2023.