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RationaleElectronic cigarettes (ECs) are becoming popular alternatives for smokers, but there has been limited study of their abuse liability.ObjectivesThe 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.MethodsEnrolled 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.ResultsUse 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.ConclusionsCollectively, 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: NCT02269514Electronic supplementary materialThe online version of this article (doi:10.1007/s00213-017-4665-y) contains supplementary material, which is available to authorized users.

RationaleWe 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.ObjectiveUsing 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.MethodsSix-hour nicotine uptake and ratings of subjective effects were used to determine abuse liability and pharmacokinetics.ResultsUse 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.ConclusionThese 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 registrationClinicalTrials.gov identifier: NCT02664012Electronic supplementary materialThe online version of this article (10.1007/s00213-018-4904-x) contains supplementary material, which is available to authorized users.

ABSTRACT. Wehman P, Kregel J, Keyser-Marcus L, Sherron-Targett P, Campbell L, West M, Cifu DX. Supported employment for persons with traumatic brain injury: a preliminary investigation of long-term follow-up costs and program efficiency. Arch Phys Med Rehabil 2003;84:192-6. Objective: To investigate the long-term follow-up costs of supported employment as well as the wage and employment characteristics for individuals with moderate to severe traumatic brain injury (TBI) who participated in supported employment services over a 14-year time period.Design: Longitudinal design with prospectively collected data.Setting: A university-based supported employment program that uses the individual placement model of supported employment.Participants: Fifty-nine individuals with moderate to severe TBI who were consecutively referred for supported employment services. The sample was restricted to individuals who were placed into a least 1 supported employment position during the study period.Interventions: Not applicable. Main Outcome Measures: Data were collected on clients placed into at least 1 competitive supported employment position from 1985 to 1999. Analyses were performed to examine the costs of supported employment, employment characteristics (eg, wages, length of employment), and benefit-cost ratios of supported employment for individuals with TBI.Results: The average length of employment for the current sample was 42.58 months. Average gross earnings were $26,129.74 for individuals during their entire duration of employment. Billing charges accrued for employment services averaged $10,349.37. Individuals with TBI earned an average of $17,515 more than the costs associated with their supported employment.Conclusions: Our investigation provides additional support for the conclusion that supported employment is cost effective for individuals with disabilities, including individuals with TBI, and that the costs of supported employment decrease over time.

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.

Many regulatory bodies now recommend tobacco product manufacturers provide information regarding new tobacco products’ abuse liability, to inform regulatory authorization of currently marketed tobacco products or new product applications (including premarket tobacco product applications in the US). In addition, the US Food and Drug Administration (FDA) recommends including this information as part of modified risk tobacco product applications. Regulators, including FDA, and many public health officials and researchers consider abuse liability assessment a model which predicts the likelihood that use of the tobacco product would result in addiction and be used repeatedly or even sporadically resulting in undesirable effects. Abuse liability of a new, potentially reduced harm product can also inform its ability to substitute completely for more harmful tobacco products. While many methods exist, no standard tobacco product abuse liability assessment has been established. The purpose of this paper is to provide background information and practical recommendations for human abuse liability testing methods to meet tobacco regulatory needs. A combination of nicotine test product pharmacokinetic, subjective effect and/or behavioral response, and physiological response data relative to comparator products with known abuse liability satisfies some regulatory requirements. Implications This review provides a practical inspection of the current, international regulatory recommendations for abuse liability assessment of tobacco, regulatory review of such information within the U.S., and recommends study designs and methods for abuse liability testing of tobacco products based on scientific and regulatory knowledge. Given that tobacco product abuse liability testing is of increasing interest to regulatory bodies globally, especially with the emergence of novel tobacco products, this timely work provides background and functional recommendations for tobacco product abuse liability testing.

Findings from a national survey of state mental retardation/developmental disability agencies regarding use of the Medicaid Home and Community Based Waiver to fund supported employment were reported. Numbers of individuals and funding levels were requested for day habilitation services for FYs 1997 and 1999, before and after the(P.L. 105-33), which removed eligibility restrictions for this service. Findings show that growth rates for this service far exceeded growth rates for other day services, with high growth rates in a small number of states. However, supported employment accounted for less than 16% of those receiving day habilitation services through the Waiver and only 12% of day habilitation funding, with the remainder going to day support, prevocational services, and other segregated options.

SUMMARYA series of ambulatory clinical studies were conducted to evaluate changes in biomarkers of tobacco exposure and subjective product ratings when adult smokers switched to dual use of cigarettes with Camel Strips (Strips), Camel Sticks (Sticks), or Camel (SNUS). In all studies, subjects smoked ad libitum for one week (baseline). In incremental stages over three subsequent weeks, subjects were instructed to reduce cigarettes per day (CPD) by at least 75% and include use of one type of smokeless tobacco product (STP). Product use data was recorded by subjects daily, questionnaires were administered and smoked cigarette filters and used snus pouches were collected weekly, and 24-hour urine samples were collected at baseline and the end of dual use for measurement of biomarkers of tobacco exposure. In total, 100 subjects were enrolled, and 88 completed the studies. At the end of dual use, mean CPD reductions of approximately 60% were reported in all studies. Median levels of biomarkers of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and acrolein either did not statistically significantly change or showed statistically significant decreases in all studies. Serum and urinary nicotine biomarkers did not significantly change. Twentyfive additional biomarkers were measured only in the SNUS study. Of those, 18 biomarkers statistically significantly decreased 12.4-35.7%. No statistically significant increases in biomarker levels were observed in any of the studies. Decreases in some biomarkers confirmed that smoking reductions occurred but were less than the reported CPD reductions. Mouth-level exposure estimates suggest subjects did not significantly alter their puffing behavior to compensate for decreased CPD. Acceptability ratings of cigarettes decreased significantly during dual use, while ratings of Strips and SNUS increased, suggesting that the change in use behavior affected subjects' perceptions of the products. Results from these studies suggest that smokers who switch to dual use with either dissolvable tobacco or snus will likely not increase tobacco constituent exposure and may reduce exposure to some tobacco toxicants, especially those associated with combustion. [Beitr. Tabakforsch. Int. 26 (2015)