RESUMO
BACKGROUND: Electronic nicotine delivery systems (ENDS) offer a promising approach to tobacco harm reduction, but many people use both ENDS and combustible cigarettes ("dual use"), which undermines potential risk reduction. To explore the role of ENDS nicotine delivery in promoting switching to ENDS, we conducted a study in which people who smoked cigarettes were offered an ENDS that had previously been shown to replicate the rapid nicotine pharmacokinetics of combustible cigarettes (BIDI® Stick). METHODS: Twenty-five cigarette smoking adults, not seeking smoking cessation treatment, but open to using ENDS as a cigarette substitute, were provided with a 12-week supply of BIDI® Stick in tobacco or menthol flavors, during a study that included seven biweekly sessions and a 6-month follow-up. Daily diaries assessed ENDS and cigarette use, and exhaled carbon monoxide (eCO) served as an objective marker of smoke intake. Subjective ratings were collected to assess the rewarding properties of ENDS and combustible cigarettes, and indices of nicotine dependence. RESULTS: Over 12 weeks, ENDS use increased to an average of 15.8 occasions per day (SD = 20.2) and self-reported cigarette consumption decreased by 82% from 16.7 cigarettes/day (SD = 6.0) at baseline to 3.0 cigarettes/day (SD = 4.1) at week 12. The eCO level decreased by 27% from an average of 20.0 ppm (SD = 9.8) at baseline to 14.5 ppm (SD = 9.9) at week 12. Four of 25 participants completely switched to ENDS and were smoking abstinent during weeks 9-12. At 6 months one participant was confirmed to be abstinent. Ratings of subjective reward for the ENDS were very similar to those of participants' usual brands of cigarettes. Dependence level was lower for the ENDS than for combustible cigarettes. CONCLUSIONS: In this study, the ENDS effectively replicated the subjective rewarding effects of participants' usual brands of cigarettes and led to a substantial reduction in reported cigarettes/day. Exhaled CO showed less of a decrease, possibly due to compensatory smoking behavior and/or the timing of eCO measurements that might not have reflected smoke intake throughout the day. The relatively low rate of sustained smoking abstinence at 6 months suggests that additional approaches continue to be needed for achieving higher rates of complete switching. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05855343.
Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Nicotina , Redução do Consumo de Tabaco , Humanos , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Nicotina/administração & dosagem , Redução do Consumo de Tabaco/métodos , Monóxido de Carbono/análise , Monóxido de Carbono/metabolismo , Produtos do Tabaco , Adulto Jovem , Abandono do Hábito de Fumar/métodos , Redução do Dano , Testes Respiratórios , VapingRESUMO
BACKGROUND: Cigarette smoking is a leading cause of morbidity and mortality. For adults who smoke cigarettes and cannot or will not quit smoking, smoke-free products, such as nicotine pouches, have been recognized as a potential alternative to smoking combusted cigarettes to reduce harm due to cigarette smoking. The role of flavors in these smoke-free products in tobacco harm reduction has not been fully understood. OBJECTIVE: This study evaluates the effect of flavors in on! nicotine pouch products (research products) in the reduction of cigarette smoking among adults who smoke cigarettes in their natural environment. METHODS: This study uses a sequential, multiple assignment, randomized trial design. Approximately 400 eligible adults who smoke cigarettes will be enrolled and randomized to have access to either the Original (unflavored) on! nicotine pouch product only or a complete flavor profile (ie, Berry, Cinnamon, Citrus, Coffee, Mint, Original, and Wintergreen) of on! nicotine pouch products. After 3 weeks, participants in the Original-only arm will be randomized again, with half remaining in the Original-only arm and half having access to the complete flavor profile for another 3 weeks. Primary outcomes are expired-air carbon monoxide (CO) levels. Secondary outcomes are self-reported cigarette consumption and CO-verified cigarette abstinence. RESULTS: Recruitment and data collection started in September 2023 and is projected to last until March 2025. We anticipate completing the data analysis in 2025. As of May 2024, we have enrolled 314 participants. CONCLUSIONS: This study will provide empirical evidence about the effect that flavor availability in smoke-free products may have in reducing cigarette smoking. TRIAL REGISTRATION: ClinicalTrials.gov NCT06072547; https://clinicaltrials.gov/study/NCT06072547. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56565.
Assuntos
Aromatizantes , Humanos , Aromatizantes/administração & dosagem , Adulto , Feminino , Masculino , Abandono do Hábito de Fumar/métodos , Nicotina/administração & dosagem , Pessoa de Meia-Idade , Fumar , Produtos do TabacoRESUMO
BACKGROUND: Varenicline is efficacious for smoking cessation, but a return to smokingusually occurs after treatment ends. Electronic nicotine delivery systems (ENDS) may enhance smoking reduction and cessation by providing a behavioral substitute for smoking and may deter smoking in the long term if an individual's nicotine dependence can be transferred to ENDS. The goal of this study was to evaluate varenicline in conjunction with ENDS to promote switching to ENDS. METHODS: Twenty-five individuals who smoked cigarettes, interested in switching but not seeking cessation treatment, received ENDS for 13 weeks; during weeks 2-13 they received varenicline. Assessments included self-reported cigarette and ENDS use, expired air carbon monoxide (CO), reward ratings, tolerability/side effects, and dependence measures. RESULTS: Cigarette smoking decreased from 15.6 cigarettes/day (SD=5.6) at baseline to 2.8 cigarettes/day (SD=5.1) at week 13 (paired t(22)=10.24, p<0.0001). 28% of participants were confirmed to be abstinent in the last 4 weeks of treatment. ENDS use remained relatively constant, averaging 11.8 occasions per day (SD=10.6). Cigarette dependence (assessed by time to first use of the day) decreased after introduction of ENDS (paired t(23) = -3.27, p=0.003), and again after the first week of full-dose varenicline (paired t(23) = -4.27, p=0.0003). Dependence on ENDS did not change, starting out lower than cigarettes (paired t(21) = 5.52, p<0.0001), but ending higher (paired t(22) = 2.94, p=0.008). Smoking satisfaction declined markedly, while satisfaction for ENDS remained relatively constant. Treatment tolerability and adherence were high. CONCLUSIONS: ENDS in combination with varenicline shows promise as a means to reduce dependence on cigarettes and facilitate switching from cigarettes to ENDS.
Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Abandono do Hábito de Fumar , Produtos do Tabaco , Tabagismo , Humanos , Vareniclina/uso terapêutico , Tabagismo/tratamento farmacológicoRESUMO
RATIONALE: Current nicotine replacement products provide a much slower onset of nicotine delivery than cigarettes, and hence are only marginally effective at supplanting cigarette smoking. Therefore, more effective forms of nicotine replacement are needed. OBJECTIVES: This initial investigation characterized the pharmacokinetic (PK) and subjective effects of a novel sublingual (SL) nicotine tablet designed to deliver nicotine more rapidly to the bloodstream of smokers. METHODS: Study 1 (N = 6) characterized the pharmacokinetics of a 2 mg nicotine SL tablet in comparison to an FDA-approved, marketed 2 mg nicotine lozenge. Study 2 (N = 24) assessed subjective responses of smokers to a single use of a 1 mg and 2 mg SL tablet. RESULTS: Study 1 found that the time to maximum blood nicotine concentrations was significantly shorter for the SL tablet (14 min) than for the lozenge (82 min), and the initial rate of nicotine absorption was higher (0.4 ng/mL*min vs. 0.0 ng/mL*min), supporting the hypothesis that the SL tablet delivered nicotine more rapidly. Study 2 found that participants reported immediate relief of nicotine withdrawal symptoms after tablet administration, and craving reduction after the 2 mg tablet approached the degree reported for their usual brands of cigarettes (4.2 vs. 4.6 on a 7-point scale). Other subjective responses showed the tablet to be an appealing alternative to smoking. CONCLUSIONS: The novel SL tablet studied shows promise as a nicotine substitution strategy for tobacco harm reduction and smoking cessation treatment. Additional studies are warranted to further investigate the potential of this new approach.
Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Abandono do Hábito de Fumar , Produtos do Tabaco , Humanos , Nicotina , Comprimidos , Nicotiana , Dispositivos para o Abandono do Uso de TabacoRESUMO
INTRODUCTION: Electronic nicotine delivery systems (ENDS) may offer a much less harmful alternative to combustible cigarettes (CC) for adult smokers unwilling or unable to relinquish nicotine. However, dual use of CC and ENDS undermines potential harm reduction, and progress needs to be made to assist smokers to switch to ENDS. This study explored the promise of a novel treatment combination of the smoking cessation medication bupropion and an FDA-approved anti-seizure medication, zonisamide, to facilitate switching from CC to ENDS. Both medications have been found to reduce craving for CC and possibly offset each other's side effects. METHODS: Twenty-four smokers participated in a 13-week treatment during which they were provided with ENDS, bupropion and zonisamide. Assessments included CC and ENDS use, expired air carbon monoxide (CO), smoking withdrawal symptoms, reward ratings and tolerability/side effects. RESULTS: 33% of participants achieved biochemically confirmed, complete CC abstinence by the end of treatment. Those who did not achieve complete abstinence nonetheless showed a 44% reduction in expired air CO. Craving and other withdrawal symptoms were minimal, and CC smoking satisfaction declined markedly, while satisfaction ratings for ENDS increased over time to overtake those of CC. Side effects were generally mild, and adherence to the medication use was excellent. CONCLUSIONS: The use of combination bupropion/zonisamide to facilitate switching from CC to ENDS is a promising approach that merits follow-up randomized controlled trials. Combining short-term medication approaches with long-term nicotine substitution using ENDS may be a promising strategy to help smokers sustain smoking abstinence in the long term.