A single-blind, randomized, crossover trial of the effects of a nicotine pouch on the relief of tobacco withdrawal symptoms and user satisfaction

Abstract

We compared the effects of a 4-mg oral nicotine pouch (Zonnic pouch), with nicotine chewing gum and placebo pouch, on withdrawal discomfort after overnight tobacco abstinence. We also assessed participants' preferences, satisfaction, and consumption patterns. This was a randomized, placebo-controlled, three-way crossover study of 30 adult smokers. After overnight tobacco abstinence, subjects reported on a Visual Analog Scale (VAS; 0-100) tobacco withdrawal symptoms (craving, irritability, difficulty concentrating, and restlessness) before use and during the first hour after first product use. They then used the product throughout the study day and in the evening reported product usefulness, temporary abstinence success, and satisfaction. In a multivariate analysis, area under the curve (craving vs. time) was reduced by 23 points 60 min after taking the study medication in the nicotine pouch group, compared with 15- and 8-point decreases in the gum and placebo groups, respectively. The difference in craving ratings between the pouch and placebo was significant (p = .002). Nicotine pouch reduced irritability more than gum (difference = 9.86; p = .01). For pouch users, the odds ratio for temporary tobacco abstinence (21.5 hr) during study days (compared with gum) was 2.8 (95% CI = 0.8-8.1). Compared with the gum, the pouch was rated as significantly more "helpful to stop smoking" (difference = 20.6; 95% CI = 2.4-38.9) and "pleasant to use" (difference = 17.3; 95% CI = 2.6-32.0). The Zonnic pouch appears to be as effective at relieving craving as nicotine gum and was subjectively favored over the gum. These results suggest that the pouch will be a helpful addition to the range of existing nicotine replacement treatments.