Treating heavy smokers in primary care with the nicotine nasal spray: randomized
placebo-controlled trial.
Author(s): Stapleton JA, Sutherland G.
Affiliation(s): Cancer Research UK Health Behaviour Research Centre, Department of Epidemiology
and Public Health, University College London, London, UK. j.stapleton@ucl.ac.uk
Publication date & source: 2011, Addiction. , 106(4):824-32
AIMS: Of six established nicotine replacement therapy (NRT) formulations, only
the gum and patch have been tested without specialist clinic support in
placebo-controlled trials. We aimed to broaden the evidence base by examining if
the nicotine nasal spray (NNS) could be effective with only brief support in
general practice.
DESIGN: Randomized placebo-controlled trial.
SETTING: Twenty-seven English general practices. Participants: A total of 761
heavy smokers received brief support and 12 weeks of treatment with NNS (506) or
placebo (255).
MEASUREMENTS: The primary outcome was biochemically verified complete abstinence
from smoking throughout weeks 3-12.
FINDINGS: NNS compared with placebo more than doubled the number who successfully
stopped smoking [15.4% versus 6.7%, odds ratio (OR) = 2.6, 95% confidence
interval (CI) = 1.5-4.4]. Many participants reported minor irritant adverse
symptoms. NNS was particularly effective among those who were more highly
dependent on nicotine (OR = 6.17, 95% CI = 2.13-17.9). Of those who failed to
stop during the first week (417, 54.8%), only one (0.2%) achieved later success.
CONCLUSIONS: NNS is effective when given in primary care. The benefit was lower
than in a specialist clinic but similar to that with the nicotine patch in
primary care. Unlike most other NRT formulations, bupropion or varenicline, NNS
was especially helpful for more dependent smokers. Continuing treatment of those
initially failing was not beneficial. An initial 1-week prescription to those
more dependent on nicotine is likely to be the most cost-effective NNS treatment
protocol. These results should offer support to the effectiveness of the other
NRT formulations untested in this setting.
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