Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)

• Status: Suspended
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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 Insight™ 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: Pfizer
• Treatments: Nicotine; Varenicline

Criteria

Inclusion Criteria:

• ≥ 18 years of age

• ≥ 6th grade English literacy

• agree to use personal or study-provided smartphone/applications

• agree to complete phone-based or in-person surveys throughout 26 week study

• expired CO > 7 at baseline visit (suggesting current smoker)

• currently smoke ≥ 5 cigarettes per day

• willing to make quit attempt 7 days after baseline visit

Exclusion Criteria:

• < 18 years of age

• history of seizures or allergic reaction to varenicline

• report current suicidality

• taking anti-depressants or anti-psychotic medications

• pregnant or planning to become pregnant

• currently breastfeeding