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.
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).
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.
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.
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.
In 2012, we published a systematic review of the use nicotine by inhalation in this journal. At that time we were unable to find any studies that had measured the effects of nicotine delivery by pMDI on smoking cessation, and we are not aware of any since 2012. Our study is the first to look at nicotine by pMDI in smoking cessation. The present trial demonstrates that a simple nonproprietary nicotine inhaler, using relatively inexpensive standard technology, increases smoking cessation rates over and above nicotine patch therapy, and could usefully enhance nicotine replacement in smoking cessation treatment.
This research output has an Altmetric Attention Score of 90. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 01 January 2025.
All research outputs
#397,929
of 22,870,727 outputs
Outputs from Nicotine & Tobacco Research
#127
of 3,080 outputs
Outputs of similar age
#8,565
of 323,290 outputs
Outputs of similar age from Nicotine & Tobacco Research
#5
of 49 outputs
Altmetric has tracked 22,870,727 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 98th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 3,080 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 19.1. This one has done particularly well, scoring higher than 95% of its peers.
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We're also able to compare this research output to 49 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 89% of its contemporaries.
