Changing patterns of first e-cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA.

BACKGROUND: Understanding the role that flavors play in the population's use of e-cigarettes and the impact that flavored e-cigarette products have on the population's use of more harmful tobacco products, like conventional cigarettes, has been identified by the US Food and Drug Administration (FDA) as a public health research priority. The purpose of the study was to assess the first e-cigarette flavor and current e-cigarette flavors used by a large non-probabilistic sample of adult frequent users of e-cigarettes in the USA and assess how flavor preferences vary by cigarette smoking status and time since first e-cigarette purchase. METHODS: An online survey assessed the first e-cigarette flavor and current e-cigarette flavors used by a non-probabilistic sample of 20,836 adult frequent e-cigarette users in the USA. Differences in e-cigarette flavor preferences between current smokers, former smokers, and never-smokers and trends in the first flavor used across time of e-cigarette use initiation were assessed. RESULTS: The majority (n = 15,807; 76.4%) of sampled frequent e-cigarette users had completely substituted e-cigarettes for conventional cigarettes-"switchers"-and were currently using rechargeable, refillable vaping devices. Among them, the proportion of first e-cigarette purchases that were fruit-flavored increased from 17.8% of first purchases made before 2011 to 33.5% of first purchases made between June 2015 and June 2016. Tobacco-flavored first purchases almost halved during this time (46.0% pre-2011 to 24.0% between 2015 and 2016). Fruit/fruit beverage (73.9 to 82.9% of sampled users), dessert/pastry (63.5 to 68.5% of sampled users), and candy, chocolate, or sweets (48.7 to 53.4% of sampled users) were the most popular currently used e-cigarette flavors. Tobacco and menthol flavors, the two most popular flavors for initiating e-cigarette use prior to 2013, now rank as the 5th and 6th most popular currently used e-cigarette flavors, respectively. CONCLUSIONS: Adult frequent e-cigarette users in the USA who have completely switched from smoking cigarettes to using e-cigarettes are increasingly likely to have initiated e-cigarette use with non-tobacco flavors and to have transitioned from tobacco to non-tobacco flavors over time. Restricting access to non-tobacco e-cigarette flavors may discourage smokers from attempting to switch to e-cigarettes

Changing patterns of first e-cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA

Abstract Background Understanding the role that flavors play in the population’s use of e-cigarettes and the impact that flavored e-cigarette products have on the population’s use of more harmful tobacco products, like conventional cigarettes, has been identified by the US Food and Drug Administration (FDA) as a public health research priority. The purpose of the study was to assess the first e-cigarette flavor and current e-cigarette flavors used by a large non-probabilistic sample of adult frequent users of e-cigarettes in the USA and assess how flavor preferences vary by cigarette smoking status and time since first e-cigarette purchase. Methods An online survey assessed the first e-cigarette flavor and current e-cigarette flavors used by a non-probabilistic sample of 20,836 adult frequent e-cigarette users in the USA. Differences in e-cigarette flavor preferences between current smokers, former smokers, and never-smokers and trends in the first flavor used across time of e-cigarette use initiation were assessed. Results The majority (n = 15,807; 76.4%) of sampled frequent e-cigarette users had completely substituted e-cigarettes for conventional cigarettes—“switchers”—and were currently using rechargeable, refillable vaping devices. Among them, the proportion of first e-cigarette purchases that were fruit-flavored increased from 17.8% of first purchases made before 2011 to 33.5% of first purchases made between June 2015 and June 2016. Tobacco-flavored first purchases almost halved during this time (46.0% pre-2011 to 24.0% between 2015 and 2016). Fruit/fruit beverage (73.9 to 82.9% of sampled users), dessert/pastry (63.5 to 68.5% of sampled users), and candy, chocolate, or sweets (48.7 to 53.4% of sampled users) were the most popular currently used e-cigarette flavors. Tobacco and menthol flavors, the two most popular flavors for initiating e-cigarette use prior to 2013, now rank as the 5th and 6th most popular currently used e-cigarette flavors, respectively. Conclusions Adult frequent e-cigarette users in the USA who have completely switched from smoking cigarettes to using e-cigarettes are increasingly likely to have initiated e-cigarette use with non-tobacco flavors and to have transitioned from tobacco to non-tobacco flavors over time. Restricting access to non-tobacco e-cigarette flavors may discourage smokers from attempting to switch to e-cigarettes

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial).

IntroductionCytisinicline (known as cytisine), a nicotinic acetylcholine receptor partial agonist, is a smoking cessation aid currently marketed in Central and Eastern Europe using a 1.5-mg/tablet 25-day downward titration schedule. No prior studies have evaluated other doses or administration schedules. This study evaluated the effects of a higher dosage and simplified dosing schedule on drug efficacy and tolerability.MethodsORCA-1 was a double-blind, randomized, placebo-controlled clinical trial that provided cytisinicline or placebo tablets plus behavioral support for 25 days. Adult smokers (>10 cigarettes daily) committed to quitting smoking were randomized to compare 2 cytisinicline doses (1.5 mg and 3 mg) versus placebo, and 2 administration schedules [downward titration versus 3 times daily (TID)]. Primary outcome was a reduction in expected cigarettes smoked at end of treatment; secondary outcomes were biochemically confirmed 7-day abstinence at Week 4 and continuous abstinence from Weeks 5 to 8.ResultsAmong 254 participants, those in cytisinicline arms (regardless of dose or schedule) had greater reductions in cigarettes smoked versus placebo, with differences observed in 3 cytisinicline arms statistically significant versus placebo. All cytisinicline arms had statistically significantly higher abstinence rates at Week 4 versus placebo. Both cytisinicline arms using TID schedules had statistically significantly higher continuous abstinence rates from Weeks 5 to 8 compared with placebo. Participants in the cytisinicline 3-mg TID arm had the highest abstinence rate. There were no safety concerns with either 1.5-mg or 3-mg cytisinicline.ConclusionBased on simpler dose scheduling, excellent tolerability, and best-continued abstinence rate, cytisinicline 3-mg TID was selected for future Phase 3 studies.ImplicationsAlthough the 1.5-mg 25-day titration schedule has been marketed in Central and Eastern Europe for decades, this study explored using a higher dosage and a simplified dosing schedule for impact on cytisinicline efficacy and tolerability. Based on these results, a Phase 3 program was initiated using cytisinicline 3-mg tablets on a TID schedule for potential market approval in the United States

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell)-3

<p><b>Copyright information:</b></p><p>Taken from "Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell)"</p><p>http://www.biomedcentral.com/1472-6904/7/11</p><p>BMC Clinical Pharmacology 2007;7():11-11.</p><p>Published online 8 Oct 2007</p><p>PMCID:PMC2194660.</p><p></p>otine lozenges for abrupt quitting over the first 6 months of the French efficacy trial

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell)-1

<p><b>Copyright information:</b></p><p>Taken from "Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell)"</p><p>http://www.biomedcentral.com/1472-6904/7/11</p><p>BMC Clinical Pharmacology 2007;7():11-11.</p><p>Published online 8 Oct 2007</p><p>PMCID:PMC2194660.</p><p></p>nicotine lozenge (unconnected data points). Consecutive blood samples (connected data points) were drawn after administration of dose 12 (t = 11 h), and the derived data points are connected. Plasma concentrations obtained with 1 mg lozenges were doubled for ease of comparison

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell)-2

<p><b>Copyright information:</b></p><p>Taken from "Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell)"</p><p>http://www.biomedcentral.com/1472-6904/7/11</p><p>BMC Clinical Pharmacology 2007;7():11-11.</p><p>Published online 8 Oct 2007</p><p>PMCID:PMC2194660.</p><p></p>mg nicotine lozenge or 4 mg nicotine gum (unconnected data points). Consecutive blood samples (connected data points) were drawn after administration of dose 12 (t = 11 h)

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell)-0

<p><b>Copyright information:</b></p><p>Taken from "Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell)"</p><p>http://www.biomedcentral.com/1472-6904/7/11</p><p>BMC Clinical Pharmacology 2007;7():11-11.</p><p>Published online 8 Oct 2007</p><p>PMCID:PMC2194660.</p><p></p>drawn before administration of each single dose (unconnected data points). Consecutive blood samples (connected data points) were drawn after administration of dose 1 (t = 0) and dose 12 (t = 11 h). The insert shows a blood nicotine peak after dosing at steady state obtained with blood draws after dose 12 (11–12 h)