"In spite of the high predictive validity of existing ALA methodology, the actual abuse liability of any product, including MRTP/PREPs, will ultimately depend on the findings from clinical trials and post-marketing surveillance. However, the predictive validity of the procedures for assessing abuse liability described in this review has been clearly established across many other classes of medications. This provides a good degree of certainty that they will also be valid for assessing new nicotine-containing products. Nonetheless, future MRTP/PREP abuse liability trials might involve designs that include both inpatient and outpatient assessment methods (e.g., 90, 115, 136) to further enhance the validity and generalizability of these laboratory-based assessments to “real-world” abuse and addiction."
How do individual constituents of a product and the potential interactions between constituents, particularly non-nicotine constituents, affect abuse liability?
How do product design features including sensory characteristics and ease of use affect the abuse liability of new products?
How do marketing, packaging, labeling, pricing, and consumer perceptions affect the abuse liability of a product?
How do patterns of use and abuse liability differ in various target populations? These include adolescents (for initiation of use), occasional smokers, regular light smokers, regular heavy smokers, smokers who want to quit, smokers with comorbid health or psychiatric disorders, smokers of different racial/ethnic groups and smokers of lower socioeconomic status.
In order to address these questions, collaboration among scientists with a broad array of expertise is critical (e.g., toxicologists, engineers, neurobiologists, social scientists, behavioral scientists, and individuals in communications and marketing) along with a conceptual framework that describes important predictors of abuse liability and critical areas of investigation for the assessment of abuse liability."
Abuse Liability Assessment of Tobacco Products Including Potential Reduced Exposure Products (PREPs)
How do individual constituents of a product and the potential interactions between constituents, particularly non-nicotine constituents, affect abuse liability?
How do product design features including sensory characteristics and ease of use affect the abuse liability of new products?
How do marketing, packaging, labeling, pricing, and consumer perceptions affect the abuse liability of a product?
How do patterns of use and abuse liability differ in various target populations? These include adolescents (for initiation of use), occasional smokers, regular light smokers, regular heavy smokers, smokers who want to quit, smokers with comorbid health or psychiatric disorders, smokers of different racial/ethnic groups and smokers of lower socioeconomic status.
In order to address these questions, collaboration among scientists with a broad array of expertise is critical (e.g., toxicologists, engineers, neurobiologists, social scientists, behavioral scientists, and individuals in communications and marketing) along with a conceptual framework that describes important predictors of abuse liability and critical areas of investigation for the assessment of abuse liability."
Abuse Liability Assessment of Tobacco Products Including Potential Reduced Exposure Products (PREPs)
