Randomised controlled trial of nasal nicotine spray in smoking cessation

Lancet. 1992 Aug 8;340(8815):324-9. doi: 10.1016/0140-6736(92)91403-u.


Studies with nicotine chewing gum and nicotine skin patches indicate that nicotine replacement can help people to give up smoking. The rapidity with which nicotine is absorbed when given as a nasal spray suggests that it might be effective for those for whom the other means of replacement are too slow. The efficacy and safety of a nasal nicotine spray as an adjunct to group treatment for stopping smoking were assessed in a randomised, double-blind, placebo-controlled trial in which 227 cigarette smokers attending the Maudsley Hospital Smokers Clinic received 4 weeks of supportive group treatment plus active nicotine (0.5 mg per shot) or placebo nasal spray. The main end-point was biochemically validated complete abstinence from smoking from the third week of group treatment until the 12-month follow-up. Side-effects were assessed by self-reports and, where necessary, by physical examination. Of subjects assigned to active treatment 26% (n = 30) were validated abstinent throughout the year, compared with 10% (n = 11) of those assigned to placebo (relative abstinence rate 2.6, 95% CI 1.5-4.5, p less than 0.001). The advantage of the active spray was greatest in the heaviest smokers. Plasma nicotine concentrations from the spray were typically between one-half and three-quarters of baseline smoking levels. Tobacco-withdrawal symptoms, craving for cigarettes, and weight gain in abstinent subjects were reduced by the active spray. Minor irritant side-effects were frequent in both active and placebo sprays, but only 2 subjects had the spray discontinued as a result. No serious adverse effects were encountered. Nasal nicotine spray combined with supportive group treatment is an effective aid to smoking cessation.

Publication types

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

MeSH terms

  • Administration, Intranasal
  • Adult
  • Breath Tests
  • Carbon Monoxide / analysis
  • Combined Modality Therapy
  • Cotinine / blood
  • Double-Blind Method
  • Female
  • Humans
  • London / epidemiology
  • Male
  • Middle Aged
  • Nicotine / administration & dosage*
  • Nicotine / blood
  • Nicotine / therapeutic use
  • Occupations
  • Outpatient Clinics, Hospital
  • Psychotherapy, Group / standards
  • Smoking / blood
  • Smoking / psychology
  • Smoking / therapy*
  • Smoking Cessation / methods*
  • Surveys and Questionnaires


  • Nicotine
  • Carbon Monoxide
  • Cotinine