The assessment of abuse liability (AL) of Electronic Nicotine Delivery Systems (ENDS) is an important factor in tobacco product regulation. We conducted a randomized, open label, crossover study to assess elements of AL of Vuse Alto ENDS using e-liquids at two nicotine levels.

Fifty smokers (27 male/23 female) were enrolled in a 9-day confinement study to assess the AL of Vuse Alto ENDS using a tobacco flavored e-liquid at two nicotine levels, 2.4% (27.4mg/ml) and 5% (57.8mg/ml), against combustible cigarette (CC) and nicotine gum (high- and low- AL comparators, respectively).

Subjects participated in four test sessions in confinement (each following a consecutive 1.5-day product acclimation and 12-hour nicotine abstinence period). During each test session, subjects used the assigned product (based on a Williams design) ad libitum for either 10 minutes (cigarette and ENDS) or 30 minutes (nicotine gum). Blood samples, subjective measures, vital signs, and adverse events were collected over 4 hours prior to, during, and following product use.

Endpoints including Product Liking, Overall Intent to Use Again [OIUA], Product Effects, Urge to Smoke [UTS], Overall Product Liking, nicotine pharmacokinetics [PK] and physiological effects were assessed following the start of product use. Both ENDS had lower scores for Product Liking, OIUA, Product Effects, Overall Product Liking; and baseline-adjusted nicotine PK less than CC, but greater than nicotine gum. ENDS had similar UTS compared to CC. These results are consistent with previous AL studies and provide additional evidence to support the conclusion that Vuse Alto has an AL between CC and nicotine replacement therapies and provides sufficient levels of nicotine to enable some adult cigarette smokers to transition to use of Vuse Alto.