Combination Rapid-Acting Nicotine Mouth Spray and Nicotine Patch Therapy in Smoking Cessation

INTRODUCTION: Improved smoking cessation rates are urgently required if New Zealand is to reach its target of a smokefree nation by 2025, during which some 600,000 smokers will need to quit. Nicotine replacement therapy remains a core part of the pharmacological approach to smoking cessation. Oral nicotine solutions with rapid onset have recently become available. We have examined the effect of a nicotine spray and a nicotine patch on smoking cessation for 12 months. METHODS: We enrolled potential participants-smokers wanting to quit aged 18-70 years, who smoked ≥9 cigarettes per day-with Fagerström Test of Nicotine Dependence score ≥3 in a double-blind trial in 3 trial sites. Smokers were randomized to a nicotine or placebo spray for 6 months, and all received nicotine patches daily for 5 months. They were followed at regular intervals for 12 months. RESULTS: A total of 1,423 subjects were randomized to nicotine oral spray (1mg of nicotine free base per spray) plus nicotine patch or a placebo spray and nicotine patch. The nicotine mouth spray plus nicotine patch showed significant improvements in prolonged abstinence for all measures to 6 months (7 consecutive days at each visit for 6 months: 15.5% vs. 10.6%; p = .006) for the combination versus placebo and nicotine patch. Thereafter, the differences were not significant. CONCLUSIONS: The addition of a nicotine mouth spray to a nicotine replacement patch in a population of smokers receiving a low level of behavioral support improved early quitting, but the effects were not sustained.