Triple Smoking Cessation Therapy with Varenicline, Nicotine Patch and Nicotine Lozenge: A Pilot Study to Assess Tolerability, Satisfaction, and End-of-Treatment Quit Rates.

Introduction: The majority of attempts to stop smoking end in failure. One way to improve success may be to explore different combinations of existing cessation medications.

Aims: This observational study examined "triple therapy" (varenicline + nicotine patch + nicotine lozenge) in 36 smokers trying to quit.

Methods: A 12-week, observational study exploring tolerability, via adverse events (AEs) elicited at each of 9 phone assessments. Secondary outcomes included satisfaction rates, medication changes, and self-reported quit rates at week 12.

Results: 35 of 36 participants reported at least one AE. Insomnia (75%), abnormal dreams (72%) and nausea (64%) were most common. Most were mild to moderate. No deaths, hospitalizations, cardiovascular events, or suicidality were reported. Six participants (17%) decreased the dose of at least one medication, 5 (14%) decreased the dose then discontinued at least one medication, and 13 (36%) discontinued at least one medication without trying a lesser dose. Participants were highly satisfied with their medications, and 58% reported quitting at 12 weeks, with 38% reporting prolonged abstinence.

Conclusion: Despite high rates of AEs and medication changes, high rates of satisfaction and self-reported quitting, with no serious AEs, were observed with triple therapy. Additional data on tolerability and efficacy are needed.

Trial registration: clinicaltrials.gov number NCT02681510.