PMID- 30524509 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220330 IS - 1834-2612 (Print) IS - 1834-2612 (Electronic) IS - 1834-2612 (Linking) VI - 13 IP - 3 DP - 2018 Sep TI - Triple Smoking Cessation Therapy with Varenicline, Nicotine Patch and Nicotine Lozenge: A Pilot Study to Assess Tolerability, Satisfaction, and End-of-Treatment Quit Rates. PG - 145-153 LID - 10.1017/jsc.2017.18 [doi] AB - 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. FAU - Berg, Kristin M AU - Berg KM AD - Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, 2828 Marshall Ct, Suite 100, Madison, WI USA 53705. AD - Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, 1930 Monroe St, Suite 200, Madison, WI USA 53711. AD - Primary Care Research Fellowship, Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, 1100 Delaplaine Ct, Madison, WI USA 53715. FAU - Jorenby, Douglas E AU - Jorenby DE AD - Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, 1930 Monroe St, Suite 200, Madison, WI USA 53711. FAU - Baker, Timothy B AU - Baker TB AD - Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, 1930 Monroe St, Suite 200, Madison, WI USA 53711. FAU - Fiore, Michael C AU - Fiore MC AD - Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, 1930 Monroe St, Suite 200, Madison, WI USA 53711. LA - eng SI - ClinicalTrials.gov/NCT02681510 GR - P01 CA180945/CA/NCI NIH HHS/United States GR - R35 CA197573/CA/NCI NIH HHS/United States PT - Journal Article DEP - 20170925 PL - England TA - J Smok Cessat JT - Journal of smoking cessation JID - 101478447 PMC - PMC6277035 MID - NIHMS906353 COIS- Conflict of Interest Author KMB has no conflicts of interest, authors DEJ, TBB, and MCF have no conflicts of interest although have received federal grants in the past 3 years. EDAT- 2018/12/14 06:00 MHDA- 2018/12/14 06:01 PMCR- 2019/09/01 CRDT- 2018/12/08 06:00 PHST- 2018/12/08 06:00 [entrez] PHST- 2018/12/14 06:00 [pubmed] PHST- 2018/12/14 06:01 [medline] PHST- 2019/09/01 00:00 [pmc-release] AID - 10.1017/jsc.2017.18 [doi] PST - ppublish SO - J Smok Cessat. 2018 Sep;13(3):145-153. doi: 10.1017/jsc.2017.18. Epub 2017 Sep 25.