Results from three independent smoking cessation clinical trials with very low nicotine (“VLN”) cigarettes are expected to be available this year. These trials will be instrumental for the further development of X-22, 22nd Century’s prescription-based smoking cessation aid in development consisting of a kit of VLN cigarettes.
Queen Mary University of London, in collaboration with Pfizer Inc., is conducting a smoking cessation clinical trial with approximately 200 subjects to evaluate whether the use of 22nd Century’s VLN cigarettes in combination with medication (Chantix or NRT) increases quitting rates over the use of Chantix or NRT alone (ClinicalTrials.gov Identifier NCT01250301). This trial will be completed in June 2012.
The Clinical Trials Research Unit, University of Auckland completed a Phase III/IV smoking cessation trial with 1,410 subjects; half received VLN cigarettes plus NRT (nicotine patch, gum and/or lozenge) and half received only NRT. Results were presented at the Society for Research on Nicotine and Tobacco (SRNT) European meeting in 2011. The subjects treated with VLN cigarettes plus NRT had significantly higher quitting rates at all measured time points (3 weeks, 6 weeks, 3 months and 6 months) than subjects treated with NRT only. A report of this study has been accepted for publication in Addiction.
The University of Minnesota Masonic Cancer Center recently completed a Phase II trial, Innovative Interventions for Smoking Cessation (ClinicalTrials.gov Identifier NCT01050569). A total of approximately 219 subjects received one of three treatments: exclusive use of 22nd Century’s VLN cigarette, exclusive use of a 21-mg nicotine patch, and use of the nicotine patch and VLN cigarette concurrently. This is a follow-up to a previously reported study comparing VLN cigarettes, reduced nicotine cigarettes, and nicotine lozenges (Hatsukami et al. 2010)