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

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

Nicotine replacement therapy (NRT) is the mainstay of pharmacological cessation therapy in New Zealand, and nicotine gum, lozenges and patches are provided free to all smokers. Newer fast-acting nicotine replacements such as oral nicotine sprays are not subsidized but have recently become available. This study led by ASPIRE2025 researchers, Brent Caldwell and Julian Crane tested the effectiveness of Zonnic (a new nicotine mouth-spray which helps reduce cravings for cigarettes) taken together with nicotine patches.

Abstract

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.

For more information, please contact:

Brent Caldwell
University of Otago, Wellington
email: brent.caldwell@otago.ac.nz