Treating heavy smokers in primary care with the nicotine nasal spray: randomized placebo-controlled trial

Addiction. 2011 Apr;106(4):824-32. doi: 10.1111/j.1360-0443.2010.03274.x. Epub 2011 Feb 14.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Adult
  • Breath Tests
  • Carbon Monoxide / analysis
  • Cotinine / analysis
  • Double-Blind Method
  • England
  • Family Practice / statistics & numerical data
  • Female
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Nasal Sprays
  • Nicotine / administration & dosage
  • Nicotine / therapeutic use*
  • Nicotinic Agonists / administration & dosage
  • Nicotinic Agonists / therapeutic use*
  • Odds Ratio
  • Patient Education as Topic / organization & administration
  • Recurrence
  • Smoking / drug therapy*
  • Smoking Cessation / methods
  • Smoking Cessation / statistics & numerical data*
  • Tobacco Use Disorder / drug therapy*
  • Treatment Outcome
  • Young Adult


  • Nasal Sprays
  • Nicotinic Agonists
  • Nicotine
  • Carbon Monoxide
  • Cotinine

Associated data

  • ISRCTN/ISRCTN03150596