Efficacy of a nicotine nasal spray in smoking cessation : a placebo-controlled, double-blind trial

Laboratory trials have demonstrated the efficacy of nicotine replacement in smoking cessation but absolute success rates are low. For many, nicotine gum is hard to use and transdermal nicotine is slow-acting and passive. A new, faster-acting nicotine nasal spray (NNS) can provide easily self-adminis...

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Bibliographic Details
Published in:Addiction (Abingdon, England) England), 1995-12, Vol.90 (12), p.1671-1682
Main Authors: SCHNEIDER, N. G, OLMSTEAD, R, MODY, F. V, DOAN, K, FRANZON, M, JARVIK, M. E, STEINBERG, C
Format: Article
Language:English
Subjects:
Addiction
Administration, Intranasal
Adult
Biological and medical sciences
Cessation
Dose-Response Relationship, Drug
Double-Blind Method
Drug addiction
Drug Administration Schedule
Female
Humans
Male
Medical sciences
Middle Aged
Nasal sprays
Nicotine - administration & dosage
Nicotine - adverse effects
Nicotine replacement therapy
Smoking
Smoking Cessation
Substance Withdrawal Syndrome - drug therapy
Tobacco, tobacco smoking
Toxicology
Treatment Outcome
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Summary:Laboratory trials have demonstrated the efficacy of nicotine replacement in smoking cessation but absolute success rates are low. For many, nicotine gum is hard to use and transdermal nicotine is slow-acting and passive. A new, faster-acting nicotine nasal spray (NNS) can provide easily self-administered relief from cigarette withdrawal. The NNS was tested for safety and efficacy in smoking cessation. Two hundred and fifty-five smokers were randomized to NNS or a piperine placebo. Drug use was limited to 8-32 doses/day for 6 months. Subjects were tested while smoking and at post-cessation daily (week 1) with follow-up at weeks 2, 3, 6 and at 3 months, 6 months and 1 year. Continuous abstinence analyses (CO < or = 8 ppm; no slips) showed that NNS significantly enhanced success rates over placebo overall (p < 0.001) and at all test intervals. Differences at key intervals between active and placebo were: 63% vs. 40% (day 5), 51% vs. 30% (week 3), 43% vs. 20% (6 weeks), 34% vs. 13% (3 months), 25% vs. 10% (6 months) and 18% vs. 8% (1 year). Side effects were common but tolerable. Cotinine measures showed that replacement of nicotine approximated 30% of smoking levels. Hazard functions revealed relapse risks peaked at day 1, day 5 and 3 weeks for strict abstinence. It is concluded NNS is safe, efficacious and a viable alternative treatment for smoking cessation.
ISSN:0965-2140
1360-0443
DOI:10.1111/j.1360-0443.1995.tb02837.x