Acceptability and effectiveness for withdrawal symptom relief of a novel oral nicotine delivery device: a randomised crossover trial

Abstract

Rationale: Existing nicotine replacement therapies (NRT) improve the chances of smoking cessation but are limited by either relatively slow nicotine absorption rates or unpleasant side effects, leaving scope for the development of more effective and acceptable products.

Objectives: This study aimed to test the acceptability and effectiveness for withdrawal symptom relief of a novel nicotine delivery device, the 'Nicotine Cannon' (NC), compared with three existing, equivalent products: the nicotine lozenge, mini-lozenge and nicotine inhalator.

Methods: A repeated-measures crossover trial where participants were randomised to one of two conditions (1- or 10-h abstinence) and in each condition to one of 24 possible sequence permutations to test each product for 10 min was carried out. Standard sociodemographic and smoking characteristics were assessed as well as withdrawal and NRT use symptoms before, during and after NRT use and product satisfaction after use.

Results: The results were similar across both durations of abstinence. The NC was significantly more effective than the inhalator in reducing withdrawal symptoms (F(3, 196)=3.5, p=0.015) and together with the mini-lozenge performed better than other NRT in alleviating urges to smoke (F(3, 563)=9.6, p<0.001) and desire for cigarettes within 10 min of use (F(3, 727)=26.1, p<0.001). The NC induced fewer adverse side effects than other NRT and was judged to be more enjoyable (F(3, 87)=13.56, p<0.001) and satisfying to use (F(3, 92)=12.35, p<0.001).

Conclusions: The 'Nicotine Cannon' is at least as effective as equivalent NRT in reducing withdrawal symptoms and more acceptable to users, suggesting that it would be a useful addition to existing NRT. The acceptability profile could make it particularly useful as a 'harm reduction' tool.