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EVALUATION OF THE ABUSE LIABILITY OF A NOVEL NON- TOBACCO LONG CUT SMOKELESS PRODUCT

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ABSTRACT Black Buffalo Inc. (BB) 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 products. The potential abuse liability of Black Buffalo Wintergreen Long Cut (BBLC) 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 oral product, 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 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. BBLC peaked at 30 minutes at a concentration of 14.3. 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 BBLC is less than and substantially slower than own-brand cigarettes and similar to CLC. The results demonstrated that BBLC has a lower abuse liability than own-brand cigarettes but equivalent to CLC.