A double-blind randomized trial of nicotine nasal spray as an aid in smoking cessation

Abstract

A double-blind randomized trial of nicotine nasal spray as an aid in smoking cessation. T. Blöndal, M. Franzon, A. Westin. ERS Journals Ltd 1997. ABSTRACT: The objective of the study was to evaluate the therapeutic efficacy of nicotine nasal solution (NNS) for smoking cessation from the stopping day up to 3 months. We also followed the participants for 2 yrs after ceasing smoking to assess what happens after stopping using NNS.In a placebo-controlled, double-blind, 2 yr prospective study, 157 smokers were given either NNS, one dose containing 1 mg of nicotine per 100 µL (n=79), or placebo (n=78). Treatment was continued for up to 1 yr.One day after quitting smoking, the average number of daily doses was 11 in the group assigned NNS and 14 in the group assigned the placebo, and after 6 weeks, 14 and 6 doses, respectively, among abstinent participants still using spray. After 3 months, 65% of the abstainers in the nicotine group were still using the NNS. The abstinence rates were 51, 39 and 29% after 6 weeks, 3 and 6 months, respectively, as compared to 24, 19 and 18% in the placebo group (p=0.0003; p=0.003; p=0.050). The proportion abstinent at the 1 yr (25 vs 17%) and 2 yr follow-ups (19 vs 14%) was higher among those assigned to the nicotine than to the placebo group, but not significantly so for the numbers used in the study.In conclusion, the use of nicotine nasal spray significantly increased the abstinence rate during the first 6 months following the quitting day. Eur Respir J 1997; 10: 1585-1590 The use of nicotine combined with group support during the initial period after stopping smoking, has been shown to be of value in numerous investigations. Nicotine polacrilex gum and nicotine transdermal patches [1,2] are well established as aids to smoking cessation. Other nicotine delivery systems include nasal spray [3][4][5], which has now been approved for use in 11 countries, and a nicotine inhaler [6].The aim of this study was to investigate the effect of a nicotine nasal spray (NNS) in the withdrawal phase of smoking cessation. Nicotine absorption is slow from nicotine polacrilex gum and particularly so from the transdermal patch. The serum nicotine levels attained are far below pretreatment smoking levels. Serum nicotine levels in gum users are seldom more than one third those of smoking levels [1], while the nicotine from nasal sprays is absorbed sufficiently rapidly to produce subjective effects similar to those from smoking and produce blood levels of ~40% of the smoking range [3,7].We attempted to investigate the effect of nicotine nasal spray treatment for up to 3 months and to assess the abstinence rates up to 1 yr after stopping the use of nicotine spray (2 yrs after quitting smoking). Methods Subjects and randomizationRecruitment for the study was done by newspaper advertisement in the second half of 1989. To be eligible, subjects had to be 21-68 yrs old and had to smoke at least 1 cigarette·day -1 . Subjects had to be motivated to stop smoking and be willing to adhere to the trial protocol. The ...

Adherence to Varenicline in the COMPASS Smoking Cessation Intervention Trial

“…FTND = Fagerström Test for Nicotine Dependence. (Blondal et al, 1997;Garvey et al, 2000;Hajek et al, 1999;Hurt et al, 1997;Killen et al, 2004;Lam et al, 2005;Mooney et al, 2007;Schmitz et al, 2007;Shiffman et al, 2008). Adherence data for the COMPASS trial were collected prior to the Federal Drug Administration issuing a black box warning about possible neuropsychiatric symptoms associated with varenicline in 2009 and therefore may overestimate future adherence rates for this medication.…”

Relapse prevention in UK Stop Smoking Services: current practice, systematic reviews of effectiveness and cost-effectiveness analysis.

“…155 None of the four trials reporting continuous abstinence reported point prevalence abstinence. 132,133,157,160 All of the included studies used biochemical verification to confirm non-smoking status.…”

“…Of the 16 included trials, eight reported methods used to generate their randomisation sequence, with five using computer-generated lists, 130,132,133,159,160 one stratified randomisation 162 and two block randomisation. 131,154 Only seven studies reported using an adequate method for allocation concealment, using centrally performed systems.…”

“…Thus 16 RCTs were included [130][131][132][133][154][155][156][157][158][159][160][161][162][163][164][165] (Table 32, Figure 17) and 8679 participants were included in analyses. Ten trials were conducted in the USA, one in the UK, three in Iceland, one in Japan, and the remaining study was conducted in both the UK and the USA.…”

Applying genetic approaches to the treatment of nicotine dependence

“…This method results in more rapid peak increases in blood nicotine and absorption in the brain, similar to the effects of cigarette smoking (Henningfield and Keenan, 1993). Four placebo controlled clinical trials of NS have demonstrated quit rates comparable to TN (Blondal et al, 1997;Hjalmarson et al, 1994;Schneider et al, 1995;Sutherland et al, 1992). In a meta analysis, the quitting odds ratio for NS vs placebo was 2.9, compared with 2.1 for TN vs placebo (Silagy et al, 1994).…”