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Article | Combination Nicotine Metered Dose Inhaler and Nicotine Patch for Smoking Cessation: A Randomized Controlled Trial

This exciting new study from ASPIRE2025 researchers Brent Caldwell and Julian Crane, is the first to look at nicotine by pMDI (pressurized metered dose inhaler) in smoking cessation.

 

The press release and journal abstract are shown below.

Press Release – 17 May 2016

Novel nicotine inhaler doubles smoking quit rates

A study by researchers at the University of Otago, Wellington shows that smokers who used a nicotine inhaler were twice as likely to quit smoking as smokers using a placebo inhaler.

The researchers developed and tested a novel nicotine inhaler to see whether it helps smokers to quit smoking. Participants in the study were randomly assigned to receive either a nicotine inhaler plus a nicotine patch, or a placebo inhaler plus a nicotine patch.

The results of the New Zealand study funded by the Health Research Council have been published today in the journal Nicotine and Tobacco Research.

Study team leader Professor Julian Crane from the University of Otago, Wellington, says the findings are the first evidence that inhaled nicotine from a simple standard inhaler is highly effective and substantially increases a smoker’s chances of quitting compared to the best current nicotine replacement treatment.

“Currently most smokers use nicotine patches to help them stop smoking. This study shows that if you add a nicotine inhaler to a nicotine patch, it doubles the chances of quitting over a nicotine patch alone,” says Professor Crane.

Although there is considerable interest in the use of e-cigarettes to help smokers give up tobacco, many countries, including New Zealand, are hesitant to introduce these to the market especially as they are largely unregulated and untested.

“There is considerable debate about whether inhaled nicotine is helpful for people who wish to stop smoking,” says Professor Crane.

“This is the first study to show that inhaled nicotine from a metered dose inhaler in the context of a smoker wanting to stop doubles their chances of quitting.”

The nicotine inhaler gives a metered dose of nicotine and offers an alternative therapeutic option for inhaled nicotine using a standard device that has been used for many decades for treatment of asthma.

“But unlike electronic cigarettes, the inhaler has no physical associations to smoking itself,” he says.

“It also has benefits in that it is much less likely to be used inappropriately to administer other drugs given that it is a completely sealed unit,” notes Professor Crane.

“New Zealand has been a world leader in tobacco control public policy and this new home-grown development offers a world-first opportunity to help the 80% or more of smokers who want to quit achieve their aims,” he says.

The researchers are currently looking at how to make the inhaler available to all smokers who would like to use it.

Abstract

Introduction:

In order to replicate the rewarding effects of smoking, nicotine replacement therapies must deliver nicotine via the pulmonary route. We aimed to measure the efficacy of a simple pressurized metered dose inhaler containing nicotine combined with a nicotine patch for smoking cessation.

Methods:

Double-blind randomized placebo-controlled, parallel group trial conducted at the University of Otago, Wellington, New Zealand. Five-hundred two adults (≥18 years) who smoked at least nine cigarettes per day, with a Fagerström Test for Nicotine Dependence ≥3 who wanted to quit, were randomized (1:1). Interventions: active nicotine pressurized metered dose inhaler (pMDI) plus active nicotine patch, versus placebo pMDI plus active nicotine patch. Subjects were instructed to use the aerosols for 6 months when they felt an urge to smoke and the patches daily for 5 months, reduce their smoking and quit by the end of the fourth week. Subjects were followed for 7 months. The primary outcome was prolonged 6 month not smoked on 7 consecutive days, analyzed by intention-to-treat.

Results:

For the primary outcome, 78/246 (31.71%) in the active group versus 46/256 (17.97%) in the control group were abstinent (odds ratio 2.12, 95% confidence interval 1.40 to 3.23). Adverse events were reported by 245/246 (99.6%) and 247/256 (96.5%) subjects in the active and control groups, respectively. Mild coughing which decreased with regular use was common with the nicotine aerosols.

Conclusion:

Inhaled nicotine from a metered dose inhaler combined with a nicotine patch substantially improves abstinence for 6 months amongst adult nicotine dependant smokers wanting to quit.

Citation:

Caldwell, B., Crane, J. (2016) Combination Nicotine Metered Dose Inhaler and Nicotine Patch for Smoking Cessation: A Randomized Controlled Trial. Nicotine & Tobacco Research first published online May 16. 2016 doi:10.1093/ntr/ntw093

For more information please contact:

Julian Crane
University of Otago, Wellington
email julian.crane@otago.ac.nz