RANDOMIZED CONTROLLED TRIAL OF NASAL NICOTINE SPRAY IN SMOKING CESSATION

被引:231
作者
SUTHERLAND, G [1 ]
STAPLETON, JA [1 ]
RUSSELL, MAH [1 ]
JARVIS, MJ [1 ]
HAJEK, P [1 ]
BELCHER, M [1 ]
FEYERABEND, C [1 ]
机构
[1] NEW CROSS HOSP,POISONS UNIT,LONDON SE14 5ER,ENGLAND
基金
英国医学研究理事会;
关键词
D O I
10.1016/0140-6736(92)91403-U
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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% Cl 1.5-4.5, p < 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.
引用
收藏
页码:324 / 329
页数:6
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