The results of a randomised, placebo-controlled trial evaluating the relative efficacies of nicotine lozenges, nicotine patches, bupropion, nicotine patches plus nicotine lozenges, and bupropion plus nicotine lozenges in smoking cessation has been published in the Archives of General Psychiatry.
A total of 1,504 adult smokers were recruited into this US study; all smoked an average of ≤10 cigarettes per day for at least the past 6 months and were motivated to quit smoking. Those using any other form of tobacco, currently taking bupropion, or with a current psychosis or schizophrenia diagnosis were excluded from the study. Participants were randomised in a double-blind fashion to one of the following, in addition to individual counselling sessions:
• Bupropion SR (150mg BD for 9 weeks total: 1 week prequit and 8 weeks postquit)
• Nicotine lozenge (2 or 4mg [based on dependence level] for 12 weeks postquit)
• Nicotine patch (24-hour patch; 21, 14, and 7 mg; titrated down during 8 weeks postquit)
• Nicotine patch (as above) plus nicotine lozenge (as above) combination therapy
• Bupropion SR (as above) plus nicotine lozenge (as above) combination therapy
• Placebo (matched to each of the active treatment conditions)
The main outcome measures were biochemically confirmed 7-day point-prevalence abstinence assessed at 1 week after the quit date (postquit), end of treatment (8 weeks postquit), and 6 months postquit.
The main findings were as follows:
• All active treatments produced higher rates of initial cessation and higher 7-day point-prevalence abstinence rates at 1 week, end of treatment, and 6 months postquit (with the exception of the lozenge at 1 week) relative to placebo
• The odds ratios (Ors) at 6 months post-quit were 1.63 for bupropion, 1.76 for lozenges, 1.83 for the patch, 1.74 for bupropion plus lozenge, and 2.34 for patch plus lozenge.
• With the Bonferroni-corrected P value (P = 0.0045; to control for the family-wise error when conducting multiple tests), only the nicotine patch and the two combination therapies were efficacious at 1 week and the end of treatment, and only the nicotine patch plus lozenge combination was efficacious at 6 months post-quit
• The two combination treatments were compared with monotherapy (as a composite) to determine if combination therapy was superior to monotherapy; analyses found that the patch plus lozenge treatment produced higher initial and end of treatment cessation rates but there were no other treatment differences
• There were no significant differences either between the 2 combination therapies or among the monotherapy therapies at any of the time points when the using the Bonferroni-corrected P value.
The authors conclude that the nicotine patch plus nicotine lozenge combination produced the greatest benefit relative to placebo. Despite this however, the 6-month outcome of this combination did not differ significantly from the other active cessation treatments in head-to-head comparisons.
They go on to discuss the limitations of their study, including the short-term treatment (8 weeks), lack of inclusion of varenicline, and the fact that treatment took place in the context of a longitudinal study, which may have selected participants with greater motivation to quit than smokers in the general population.