title: Efficacy of a nicotine nasal spray in smoking cessation: a placebo-controlled, double-blind trial.
abstract: 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.
authors.affiliation: West LA VA Medical Center, Los Angeles, California 90073, USA.
authors.forename: N G
authors.initials: NG
authors.lastname: Schneider
authors.forename: R
authors.initials: R
authors.lastname: Olmstead
authors.forename: F V
authors.initials: FV
authors.lastname: Mody
authors.forename: K
authors.initials: K
authors.lastname: Doan
authors.forename: M
authors.initials: M
authors.lastname: Franzon
authors.forename: M E
authors.initials: ME
authors.lastname: Jarvik
authors.forename: C
authors.initials: C
authors.lastname: Steinberg
mesh_terms: D000281:Administration, Intranasal; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects; D016540:Smoking Cessation; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy; D016896:Treatment Outcome
chemical_list: D009538:Nicotine