Effects on Abstinence of Nicotine Patch Treatment Before Quitting Smoking: Parallel, Two Arm, Pragmatic Randomised Trial

The preloading investigators. BMJ. 2018 Jun 13;361:k2164. [CrossRef] [PubMed]

The authors examined the effectiveness of a nicotine patch worn for four weeks before a quit attempt in a randomized controlled open label trial. There were 1792 adults who were daily smokers with tobacco dependence. 899 were allocated to the preloading arm and 893 to the control arm. Biochemically validated abstinence at six months was achieved by 157/899 (17.5%) participants in the preloading arm and 129/893 (14.4%) in the control arm: difference 3.0% (95% confidence interval −0.4% to 6.4%), odds ratio 1.25 (95% confidence interval 0.97 to 1.62, P=0.08). There was an imbalance between arms in the frequency of varenicline use as post-cessation treatment, and planned adjustment for this gave an odds ratio for the effect of preloading of 1.34 (95% confidence interval 1.03 to 1.73), P=0.03). The authors conclude that although evidence was insufficient to confidently show that nicotine preloading increases subsequent smoking abstinence, a beneficial effect seems to have been masked by a concurrent reduction in the use of varenicline in people using nicotine preloading.