Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)
Status:
Suspended
Trial end date:
2021-12-30
Target enrollment:
Participant gender:
Summary
Varenicline is considered to be a first-line tobacco cessation treatment. Previous studies
have evaluated the impact of the combination of varenicline and nicotine patches (versus
varenicline alone) on smoking cessation, though findings have been equivocal. No studies to
date have evaluated the combination of varenicline and oral nicotine replacement therapy
(NRT; i.e., nicotine lozenges or gum). Nicotine lozenges and gum can provide acute relief
during cravings and high risk situations, which offers individuals the flexibility to deliver
nicotine when they need it most (in contrast with the continuous and passive delivery of
nicotine offered via the patch). Prospective clinical trials are needed in real-world
settings to determine whether the combination of varenicline and oral nicotine replacement
therapy (i.e., lozenges, gum) is superior to varenicline alone for smoking cessation. The
proposed pilot randomized trial would enroll 100 participants over 1 year (≈8 participants
per month) utilizing a 2x2 factorial design. Twelve weeks of a pharmacological intervention
[varenicline + oral NRT (VAR+N) vs. varenicline alone (VAR)] will be crossed with automated
medication reminders (reminder messages vs. no reminder messages). All participants will
receive an adapted version of the standard counseling offered through the Tobacco Treatment
Research Program (TTRP).
The primary outcomes will be biochemically-verified smoking cessation at 12 and 26 weeks
following a scheduled quit attempt (1 week after enrollment). Smartphone-based ecological
momentary assessment (EMA) will be employed to measure withdrawal symptoms, medication
adherence, side effects, and adverse events using the Insightâ„¢ platform developed by the
Stephenson Cancer Center (SCC) mHealth Shared Resource. This pilot study will provide
information regarding the feasibility, acceptability, and preliminary efficacy of combination
varenicline and oral NRT for smoking cessation, which will support an NIH funding application
for a larger, adequately powered study.