RESUMEN
RATIONALE: We previously reported that following a short-term product use period, use of non-menthol Vuse Solo electronic cigarettes (ECs) resulted in product effect-related subjective responses and nicotine uptake between those of combustible cigarettes (high-abuse liability comparator) and nicotine gum (low-abuse liability comparator); the results were generally closer to those of nicotine gum. OBJECTIVE: Using a similar design to the previous study, we evaluated the abuse liability of three menthol-flavored Vuse Solo ECs with the same nicotine contents (14, 29, and 36 mg) in a group of EC-naïve, menthol cigarette smokers, relative to comparator products. METHODS: Six-hour nicotine uptake and ratings of subjective effects were used to determine abuse liability and pharmacokinetics. RESULTS: Use of menthol Vuse Solo resulted in significantly lower responses to subjective measurements (product liking, intent to use product again, and liking of positive product effects), higher urge to smoke responses, and a lower peak (Cmax) and overall extent (AUC0-360) of nicotine uptake compared to smoking the usual brand menthol cigarette. When compared with use of nicotine gum, subjective responses to use of menthol Vuse ECs were in the same direction as those resulting from smoking cigarettes but were more similar to nicotine gum use in magnitude than they were to cigarettes. CONCLUSION: These findings are concordant with our previous results and provide evidence that menthol Vuse Solo ECs have abuse liability that is lower than menthol cigarettes and potentially greater than that of nicotine gum. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02664012.
Asunto(s)
Conducta Adictiva , Sistemas Electrónicos de Liberación de Nicotina , Mentol , Chicles de Nicotina , Nicotina/administración & dosificación , Agonistas Nicotínicos/administración & dosificación , Productos de Tabaco , Adulto , Estudios Cruzados , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fumar , Nicotiana , Fumar Tabaco , Adulto JovenRESUMEN
RATIONALE: Electronic cigarettes (ECs) are becoming popular alternatives for smokers, but there has been limited study of their abuse liability. OBJECTIVES: The objective of this study was to evaluate the abuse liability of three Vuse Solo ECs, ranging from 14 to 36 mg in nicotine content, relative to high- and low-abuse liability comparator products (usual brand combustible cigarettes and nicotine gum, respectively) in a group of 45 EC-naïve smokers. METHODS: Enrolled subjects' ratings of subjective effects and nicotine uptake over 6 h were used to measure abuse liability and pharmacokinetics following in-clinic use of each EC. RESULTS: Use of Vuse Solo resulted in subjective measures and nicotine uptake that were between those of combustible cigarettes and nicotine gum, although generally closer to nicotine gum. Compared to combustible cigarettes, use of Vuse Solo resulted in significantly lower scores in measures of product liking, positive effects, and intent to use again. These pharmacodynamic findings were consistent with the pharmacokinetic data, showing that cigarettes produced substantially faster and higher levels of nicotine uptake as compared to Vuse Solo and nicotine gum. Vuse Solo resulted in more rapid initial uptake of nicotine compared to nicotine gum, but peak concentration and long-term extent of uptake were not different or were lower with Vuse. CONCLUSIONS: Collectively, these findings suggest that Vuse Solo likely has an abuse liability that is somewhat greater than nicotine gum but lower than cigarettes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02269514.
Asunto(s)
Sistemas Electrónicos de Liberación de Nicotina , Chicles de Nicotina , Nicotina/uso terapéutico , Productos de Tabaco , Adulto , Estudios Cruzados , Femenino , Encía/efectos de los fármacos , Encía/metabolismo , Humanos , Masculino , Persona de Mediana Edad , Medición de RiesgoRESUMEN
A study was conducted to evaluate biomarkers of biological effect and physiological assessments related to cardiovascular disease (CVD) among adult male cigarette smokers (SMK), moist snuff consumers (MSC) and non-consumers of tobacco (NTC). Additionally, biomarkers of tobacco and tobacco smoke exposure (BoE) were measured in spot urines and are reported here. Except for the BoE to nicotine and NNK, BoE were generally greater in SMK compared with MSC, and BoE were generally not different in comparisons of MSC and NTC. Results demonstrated that MSC had lower systemic exposures to many harmful and potentially harmful constituents than SMK, which is consistent with epidemiological data that indicate a differential in CVD risk between these groups.
Asunto(s)
Enfermedades Cardiovasculares/sangre , Fumar/sangre , Tabaquismo/complicaciones , Adulto , Biomarcadores/sangre , Enfermedades Cardiovasculares/etiología , Estudios Transversales , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Tabaquismo/sangreRESUMEN
OBJECTIVE: To investigate the relation between selected acute injury and patient characteristics and subsequent return to work 1 to 5 years postinjury. DESIGN: Longitudinal design with prospectively collected data. Data were collected on patients at the time of injury and each year postinjury for up to 5 years. SETTING: Four medical centers in the federally sponsored Traumatic Brain Injury Model Systems project that provide emergency medical services, intensive and acute medical care, inpatient rehabilitation, and a spectrum of community rehabilitation services. PARTICIPANTS: Patients were selected from a national database of 538 rehabilitation inpatients admitted to acute care within 8 hours of traumatic brain injury (TBI) and seen at 1 to 5 years follow-up. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Employment status (employed vs not employed) at 1 to 5 years postinjury. Logistic regression analyses were performed to determine the extent to which selected variables predicted employment status at years 1 to 5 postinjury. RESULTS: At year 1 postinjury, preinjury productivity, age, education, and rehabilitation length of stay were all significantly associated with postinjury employment. Preinjury employment and productivity and age significantly predicted employment at postinjury year 2. At year 3 postinjury, preinjury productivity, age, and FIMtrade mark instrument discharge score significantly predicted employment status. Age was significantly associated with employment status at year 4 postinjury. Preinjury employment and productivity and Disability Rating Scale discharge score were found to be significant predictors of postinjury employment at year 5 follow-up. CONCLUSIONS: The relationship between certain acute injury and patient variables (eg, age, preinjury productivity, education, discharge FIM) and subsequent return to work may provide rehabilitation professionals with useful information regarding the intensity and types of services needed for individuals in the vocational rehabilitation planning process.