Nic Nac lozenges are small, tobacco-free nicotine oral products containing pharmaceutical grade excipients and natural flavors. This study evaluated the abuse liability of 6 different Nic Naclozenges (3 mg and 6 mg) compared with usual-brand cigarettes (UBC) in adult smokers who had experience using oral tobacco (N=21). This randomized, open-label, 7-way crossover clinical study measured nicotine plasma concentrations, Urge to Smoke, product liking, intent to use again, and product use behaviors under controlled and ad libitum use conditions.
Following controlled-use, all Nic Nac lozenges had significantly longer Tmax compared to UBC, indicating slower delivery. Under both controlled and ad libitum use conditions, the 3 mg lozenge had a significantly lower Cmax than UBC, while Cmax values for the 6 mg lozenges were not statistically different from UBC. Differences in AUC values between the UBC and the lozenges were more variable. Under controlled-use, all lozenges suppressed Urge to Smoke similarly to UBC; under ad libitum use conditions, Urge to Smoke suppression was lower than UBC.
During ad libitum sessions, the mean number of lozenges used was consistent across products, approximately three lozenges per session. The maximum number used was higher for the Wintergreen 3 mg lozenge, with up to 10 lozenges used, compared with a maximum use of five/six lozenges for the 6 mg products. In comparison, participants smoked a mean of five, with a maximum of nine UBCs. Mean duration of use per lozenge ranged from 43.0 to 48.0 minutes for the 6 mg lozenges and was 51.5 minutes for the 3 mg lozenge. Taken together, these findings indicate that Nic Nac 3 mg and 6 mg nicotine lozenges provide nicotine delivery and subjective effects sufficient to reduce urge to smoke, but without evidence of greater abuse liability than UBC.
