Event name:
EVALUATION OF THE ABUSE LIABILITY OF A NOVEL NON- TOBACCO SMOKELESS POUCH PRODUCTSession Date:
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Session Speakers:
ABSTRACT Black Buffalo Inc. has designed a novel alternative smokeless product that is based on a common non-tobacco food plant. The non-tobacco food plant leaf is cured and processed like tobacco but does not contain TSNAs or PAHs. Tobacco derived nicotine is added to the processed leaf. Black Buffalo’s product is designed to emulate the organoleptic, ritualistic, and pharmacokinetic aspects of traditional smokeless pouch products. The potential abuse liability of Black Buffalo Wintergreen Pouches (BBP) was assessed and compared to own- brand cigarettes, Nicorette gum, and Copenhagen Long Cut Wintergreen (CLC). A randomized open label 5-way crossover in-patient clinical study was performed to evaluate the nicotine plasma levels and the subjective measures of effect. Subjects used 2 grams of CLC or one BB pouch, smoked their own cigarette or used one piece of nicotine gum under controlled conditions. Suppression of the urge to smoke was equivalent for all of the products but the time to effect was 5 minutes for own-brand cigarettes and 15 minutes for all of the other products. All of the oral products were less satisfying and less pleasant than own- brand cigarettes. Own-brand cigarette nicotine plasma levels peaked in 5.5 minutes with a maximum concentration of 19.6 ng/mL. BBP peaked at 30 minutes at a concentration of 7.1 ng/mL. CLC peaked at 30 minutes at a concentration of 13.2 ng/mL. Nicotine absorption from the Nicorette gum was slower (45 minutes peak) at a concentration of 6.6 ng/mL. The pharmacokinetic data demonstrate that nicotine absorption from BBP is less than own- brand cigarettes and CLC and similar to Nicorette gum. The results demonstrated that BBP has a lower abuse liability than own-brand cigarettes but is similar to CLC.