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Research Effects on abstinence of nicotine patch treatment before quitting smoking: parallel, two arm, pragmatic randomised trial 2018; 361 doi: https://doi.org/10.1136/.k2164 (Published 13 June 2018) Cite this as: 2018;361:k2164

Participants 1792 adults who were daily smokers with tobacco dependence. 899 were allocated to the preloading arm and 893 to the control arm.

Interventions Participants were randomised 1:1, using concealed randomly permuted blocks stratified by centre, to either standard smoking cessation pharmacotherapy and behavioural support or the same treatment supplemented by four weeks of 21 mg nicotine patch use before quitting: “preloading.”

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Main outcome measures The primary outcome was biochemically confirmed prolonged abstinence at six months. Secondary outcomes were prolonged abstinence at four weeks and 12 months.

Results 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 in the primary analysis. 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: difference 3.8% (0.4% to 7.2%). At four weeks, the difference in prolonged abstinence unadjusted for varenicline use was odds ratio 1.21 (1.00 to 1.48), difference 4.3% (0.0% to 8.7%), P=0.05, and adjusted for varenicline use was 1.32 (1.08 to 1.62) P=0.007. At 12 months the odds ratio was 1.28 (0.97 to 1.69), difference 2.7% (−0.4% to 5.8%), P=0.09 unadjusted for varenicline use and after adjustment was 1.36 (1.02 to 1.80) P=0.04. 5.9% of participants discontinued preloading owing to intolerance. Gastrointestinal symptoms—chiefly nausea—occurred in 4.0% (2.2% to 5.9%) more people in the preloading arm than control arm. Eight serious adverse events occurred in the preloading arm and eight in the control arm (odds ratio 0.99, 0.36 to 2.75).

Conclusions Evidence was insufficient to confidently show that nicotine preloading increases subsequent smoking abstinence. The beneficial effect seems to have been masked by a concurrent reduction in the use of varenicline in people using nicotine preloading, and future studies should explore ways to mitigate this unintended effect.

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Although there have been several new drugs for tobacco cessation since the 1970s, the paradigm of treatment has remained largely the same, with no major advances in success rates. Treatment comprises behavioural support to motivate and strengthen a person’s resolve to remain abstinent and drugs to reduce the strength of urges to smoke after quit day.

Most adult smokers want to stop smoking but continue because they have developed a drive to smoke. Repeated pairing of smoking behaviour with stimulation of cholinergic receptors in the midbrain that project to the nucleus accumbens is an important factor contributing to this drive.1 The urge to smoke can remain largely unconscious, but when a smoker decides to quit a craving is experienced, typically in response to moods or situations when smoking would normally have occurred. These cravings undermine the success of most quit attempts.2 Effective smoking cessation drugs exert their effect by reducing the intensity of cravings, and the most effective drug currently available, varenicline, does so to the greatest extent.3 In people who resist the craving, repeated exposure to cues to smoke without actually smoking and the concomitant delivery of nicotine from a cigarette will mean the drive to smoke is unlearnt and craving intensity decreases.

If smoking occurs without the reinforcement provided by nicotinic stimulation, the drive to smoke should diminish and, when a smoker attempts to quit, they should experience less intense craving and be more likely to succeed. One way to block the effect of nicotine from cigarettes is to use a nicotine patch. Doing so desensitises the cholinergic brain receptors, meaning they are refractory to further stimulation from cigarette supplied nicotine.4 This should reduce the intensity of the urge to smoke while smoking and, crucially, lowered dependence will reduce craving intensity if someone makes a quit attempt, facilitating abstinence.

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Using a nicotine replacement treatment (or other smoking cessation drugs) before a quit attempt while smoking normally is called preloading. A systematic review showed some, but not convincing, evidence that nicotine preloading may be effective, with much unexplained heterogeneity between studies.5 Some studies suggested that nicotine preloading doubled the likelihood of achieving abstinence, which, if true, suggests that using nicotine replacement therapy before a quit attempt is more effective than when used in the conventional way to support smoking abstinence.6 Other studies suggested preloading had no effect. A partial explanation for the heterogeneity may relate to the form of nicotine replacement used. Smoking while using patches produces higher blood nicotine concentrations than just smoking, but smoking while using short acting nicotine replacement therapy, such as gum, does not.7 There was some but not strong evidence in the review that preloading using a nicotine patch was more effective than preloading with oral nicotine replacement therapy. Since then, three more studies using varenicline and bupropion preloading have been conducted, with some evidence of a benefit on short term cessation.8910 These studies are relevant because they examine the same hypothetical active ingredient of the preloading interventions as studies of nicotine replacement therapy—that is, the effects of reduced satisfaction from smoking. Together, these studies have provided modest support that preloading works through reducing the intensity of urges to smoke.

Given the promise and uncertainty around this novel approach to treating tobacco dependence, we conducted a large trial in a routine health service context to examine the impact of nicotine replacement therapy preloading on long term abstinence and mechanisms of its action.

This was an open label multicentre pragmatic superiority trial, with participants randomised 1:1 to receive or not receive a nicotine patch to use for four weeks before quit day. Thereafter the participants used standard pharmacotherapy and behavioural support to support cessation. The primary outcome was prolonged biochemically validated abstinence measured six months after quitting. The protocol is published and was implemented with one change11; we asked participants who had moved house and were unable to attend in person to return a supplied saliva swab to measure cotinine or anabasine concentrations to confirm abstinence. The planned cost effectiveness analysis will be presented separately.

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In three recruitment centres, based in Nottingham, Birmingham, and Bristol, general practitioners spoke or wrote to, emailed, or texted patients listed as smokers on the electronic health record and invited them to join the trial as a means to stop smoking. The fourth recruitment centre, in London, was an existing National Health Service smoking cessation clinic and invited patients seeking treatment to participate in the trial.

Potential participants telephoned the research team to learn more about the trial and were screened for eligibility. If they seemed to be eligible and wanted to participate, we booked them in for an appointment at their general practice or smoking cessation clinic to meet the researcher, and we sent them an information sheet. At this initial appointment, we again described the trial and obtained consent.

Potential participants were eligible for the study if they regularly smoked cigarettes, cigars, or roll-up tobacco cigarettes, with or without marijuana; were aged 18 years or more; would be suitable for preloading according to researcher’s judgment; were seeking support to stop smoking from the NHS stop smoking service; were willing to set a quit day in four weeks; and were able to understand and willing to adhere to study procedures. We excluded those who were pregnant or breast feeding; had skin disorders that precluded use of the patch; had acute coronary syndrome or stroke in the past three weeks; and had an active phaeocromocytoma or uncontrolled hyperthyroidism that would increase the risk of arrhythmias from the nicotine patch.

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To determine suitability for preloading we used several criteria with no cut-offs to assess whether potential participants were addicted to smoking: failure of previous quit attempts despite use of appropriate pharmacotherapy; time to first cigarette in the morning, with earlier use reflecting higher addiction; number of cigarettes smoked daily, with a greater number reflecting higher addiction; and exhaled carbon monoxide concentration, with higher values reflecting higher addiction.

We asked participants in the preloading arm to use a 21 mg/24 h nicotine patch daily for approximately four weeks before quit day. If participants had had problems with overnight use in previous quit attempts, we advised wearing the patch in waking hours only.

We asked participants to smoke as normal and not reduce consumption. Reduced consumption would probably lower blood nicotine concentration, which could make cigarettes more rewarding and thus undermine the supposed benefits of preloading.13

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Participants in both arms were referred to the NHS stop smoking service for continuing support with cessation. We asked participants and the NHS advisors by letter and in person to set a quit date between three and five weeks after commencing preloading. We allowed that preloading could continue for up to eight weeks in exceptional circumstances, and also that preloading could restart once—for example, if preloading was interrupted because the participant was admitted to hospital. In such cases, participants aimed to complete three to five weeks of preloading from