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Background and aims Nicotine replacement therapy (NRT) may be more effective in aiding smoking cessation if higher doses of nicotine from it can be tolerated. We examined the responses to, and 4-week abstinence rates observed, when titrating the dose of transdermal nicotine patch up to 84 mg/day over 4 weeks prior to a target quit date and titrating down again over 4 weeks afterwards. Design Clinical cohort study. Setting Tobacco dependence clinic, Mar del Plata, Argentina. Participants Fifty smokers seeking help with stopping smoking. Intervention Participants started on one 21-mg/24-hour patch 4 weeks prior to their target quit day (TQD). The dose was increased weekly by adding a 21-mg patch unless participants reported adverse effects and/or did not wish to increase the dose. The dose was reduced by 21 mg/day each week from 1 week post-TQD, until it reverted to the standard dose (21 mg/day) at 4 weeks post-TQD. Participants received weekly behavioural support and could also use oral NRT from the TQD. Participants were advised to smoke ad libitum during the pre-quit period. Measurements Proportion of participants progressing through each stage of dosing, adherence, adverse effects, changes in cigarette consumption, smoke intake and enjoyment of smoking during the pre-quit period; withdrawal symptoms; carbon monoxide-validated abstinence during 4 weeks post-TQD. Findings Of the 50 participants, 72.0% (n = 36) progressed to the 84-mg nicotine dose and 94.0% (n = 47) completed the trial. Adverse effects consisted primarily of nausea and were mild and well tolerated. Cigarette consumption, smoke intake and enjoyment of smoking declined significantly during the pre-quit period. Forty-one (82%) participants achieved 4 weeks validated abstinence. Abstainers experienced no detectable cigarette withdrawal symptoms. Conclusions Most smokers seeking help with stopping appear to be able to tolerate doses of transdermal nicotine patch up to 84 mg/day during a 4-week pre-quit up-titration period with minimal side effects.

Electronic cigarettes (EC) may have a potential for public health benefit as a safer alternative to smoking, but questions have been raised about whether EC should be licensed as a medicine, with accurate labelling of nicotine content. This study determined the nicotine content of the cartridges of the most popular EC brands in the United Kingdom and the nicotine levels they deliver in the vapour, and estimated the safety and consistency of nicotine delivery across batches of the same product as a proxy for quality control for individual brands and within the industry.We studied five UK brands (six products) with high internet popularity.Two samples of each brand were purchased 4 weeks apart, and analysed for nicotine content in the cartridges and nicotine delivery in vapour.The nicotine content of cartridges within the same batch varied by up to 12% relative standard deviation (RSD) and the mean difference between different batches of the same brand ranged from 1% [95% confidence interval (CI) = -5 to 7%] to 20% (95% CI=14-25%) for five brands and 31% (95% CI=21-39%) for the sixth. The puffing schedule used in this study vaporized 10-81% of the nicotine present in the cartridges. The nicotine delivery from 300 puffs ranged from ∼2 mg to ∼15 mg and was not related significantly to the variation of nicotine content in e-liquid (r=0.06, P=0.92). None of the tested products allowed access to e-liquid or produced vapour nicotine concentrations as high as conventional cigarettes.There is very little risk of nicotine toxicity from major electronic cigarette (EC) brands in the United Kingdom. Variation in nicotine concentration in the vapour from a given brand is low. Nicotine concentration in e-liquid is not well related to nicotine in vapour. Other EC brands may be of lower quality and consumer protection regulation needs to be implemented, but in terms of accuracy of labelling of nicotine content and risks of nicotine overdose, regulation over and above such safeguards seems unnecessary.

The NHS Stop Smoking Service (NHS-SSS) helps approximately half its clients to quit for 4 weeks. However, most initially successful quitters relapse within 6 months. Short message service (SMS) texting has been shown to facilitate stopping smoking. We describe the development, implementation and subsequent evaluation, in terms of practicability and client response, of an SMS text-based relapse prevention intervention (RPI) delivered within routine community and specialist National Health Service (NHS) Stop Smoking Service (SSS) provision in four Primary Care Trusts.Text messages aimed at motivation to remain abstinent, preventing careless lapses and continuing the full course of medicine for smoking cessation were developed and sent weekly to clients' mobile phones for 12 weeks and fortnightly for 6 months. They were asked to respond to some of the texts and contact the NHS SSS if they lapsed. They were also offered free nicotine mini lozenges to be sent via the mail on three occasions.NHS SSS.202 clients who had been abstinent for 4 weeks.Feasibility of introducing RPI into routine care; response to interactive messages and requests for the medication; rating of the helpfulness of RPI; self-reported and carbon monoxide (CO)-validated smoking status for up to 26 weeks.A text-based RPI was easy to implement within the NHS SSS provided by specialist advisers, but enrollment of clients from services provided by a network of pharmacists was difficult because client contact details were often lacking. Where records of the number of people invited to RPI were available, 94% of eligible participants enrolled. The RPI was well received by both SSS clients and staff, with 70% (n = 63) of clients who completed follow-up considering the intervention helpful. Eighty-five per cent (n = 172) of clients responded to at least one of the nine interactive text messages. Sixty-four clients (32% of the total, 47% of those we managed to contact) reported continuous abstinence at 6 months. Eighteen (9%) clients who relapsed to smoking used the RPI to re-engage with the NHS SSS and 10 (5%) successfully re-established abstinence.In smokers attending National Health Service Stop Smoking Services who are abstinent 4 weeks after their quit date, a relapse prevention intervention based on SMS text messaging was well received, and can be implemented economically and rapidly. A controlled trial is needed to establish whether it has a significant impact on relapse.

Background and aims Bupropion was introduced for smoking cessation following a pivotal trial showing that it gave improved efficacy over the nicotine patch and also suggesting combination treatment was beneficial. We tested in clinical practice for an effectiveness difference between bupropion and nicotine replacement therapy (NRT), whether the combination improves effectiveness and whether either treatment might be more beneficial for certain subgroups of smokers. Design Open-label randomized controlled trial with 6-month follow-up. Setting Four UK National Health Service (NHS) smoking cessation clinics. Participants Smokers (n = 1071) received seven weekly behavioural support sessions and were randomized to an NRT product of their choice (n = 418), bupropion (n = 409) or NRT plus bupropion (n = 244). Measures The primary outcome was self-reported cessation over 6 months, with biochemical verification at 1 and 6 months. Also measured were baseline demographics, health history, smoking characteristics and unwanted events during treatment. Findings Abstinence rates for bupropion (27.9%) and NRT (24.2%) were not significantly different (odds ratio = 1.21, 95% confidence interval = 0.883–1.67), and the combination rate (24.2%) was similar to that for either treatment alone. There was some evidence that the relative effectiveness of bupropion and NRT differed according to depression (χ2 = 2.86, P = 0.091), with bupropion appearing more beneficial than NRT in those with a history of depression (29.8 versus 18.5%). Several unwanted symptoms were more common with bupropion. Conclusion There is no difference in smoking cessation effectiveness among bupropion, nicotine replacement therapy and their combination when used with behavioural support in clinical practice. There is some evidence that bupropion is more beneficial than nicotine replacement therapy for smokers with a history of depression.

To determine the combined effect of very low nicotine content (VLNC) cigarettes and usual Quitline care [nicotine replacement therapy (NRT) and behavioural support] on smoking abstinence, in smokers motivated to quit.Single-blind, parallel randomized trial.New Zealand. PARTICIPANTS Smokers who called the Quitline for quitting support were randomized to either VLNC cigarettes to use whenever they had an urge to smoke for up to 6 weeks after their quit date, in combination with usual Quitline care (8 weeks of NRT patches and/or gum or lozenges, plus behavioural support) or to usual Quitline care alone.The primary outcome was 7-day point-prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, self-efficacy, alcohol use, serious adverse events and views on the use of the VLNC cigarettes at 3 and 6 weeks and 3 and 6 months.A total of 1410 participants were randomized (705 in each arm), with a 24% loss to follow-up at 6 months. Participants in the intervention group were more likely to have quit smoking at 6 months compared to the usual care group [7-day point-prevalence abstinence 33 versus 28%, relative risk (RR) = 1.18, 95% confidence interval (CI): 1.01, 1.39, P = 0.037; continuous abstinence 23 versus 15%, RR = 1.50, 95% CI: 1.20, 1.87, P = 0.0003]. The median time to relapse in the intervention group was 2 months compared to 2 weeks in the usual care group (P0.0001).Addition of very low nicotine content cigarettes to standard Quitline smoking cessation support may help some smokers to become abstinent.

To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months.Single-blind, randomized controlled trial.New Zealand.A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use.The primary outcome was 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months.No differences in 6-month quit rates (7-day point prevalence or continuous abstinence) were observed between the groups. However, smokers allocated to the intervention group were more likely to have quit smoking at 3 months [self-reported point prevalence, relative risk (RR)=1.17, 95% confidence interval (CI): 1.02, 1.35, P=0.03], had a longer time to relapse (median 70 days versus 28 days, P0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%).In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1-week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period. This trial is registered with the Australasian Clinical Trials Network Number: ACTRN 12606000451505.

To determine the effectiveness of 2 weeks' pre-cessation nicotine patches and/or gum on smoking abstinence at 6 months.Pragmatic randomized controlled trial.New Zealand.Eleven hundred adult, dependent smokers who called the New Zealand Quitline between March 2006 and May 2007 for support to stop smoking were randomized to 2 weeks of nicotine patches and/or gum prior to their target quit day followed by usual care (8 weeks of patches and/or gum plus support calls from a Quitline adviser), or to usual care alone.The primary outcome was self-reported 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cotinine-verified abstinence, daily cigarette consumption, withdrawal symptoms and adverse events.Six months after quit day 125 (22.7%) participants in the pre-cessation group and 116 (21.0%) in the control group reported 7-day point prevalence abstinence (relative risk 1.08 95% CI: 0.86, 1.35, P = 0.4, risk difference 1.7%, 95% CI: -3.2%, 6.6%). However, when pooled in a meta-analysis with other pre-cessation trials a moderate benefit of about a one-quarter increase in cessation rates was evident. There was no difference in adverse events between groups.In this, the largest pre-cessation NRT trial to date, using NRT 2 weeks before the target quit day was safe and well tolerated but offered no benefit over usual care. However, in conjunction with previous pre-cessation trials there appears to be a moderate benefit, but not as large as that seen in most smaller trials.

Many smokers believe that smoking helps them to cope with stress, and that stopping smoking would deprive them of an effective stress management tool. Changes in stress levels following long-term smoking cessation are not well mapped. This longitudinal project was designed to provide more robust data on post-cessation changes in perceived stress levels by following a cohort of smokers admitted to hospital after myocardial infarction (MI) or for coronary artery bypass (CAB) surgery, as such patients typically achieve higher continuous abstinence rates than other comparable samples.A total of 469 smokers hospitalized after MI or CAB surgery and wanting to stop smoking were seen in the hospital and completed 1-year follow-ups. Ratings of helpfulness of smoking in managing stress at baseline, smoking status (validated by salivary cotinine concentration) and ratings of perceived stress at baseline and at 1-year follow-up were collected.Of the patients, 41% (n = 194) maintained abstinence for 1 year. Future abstainers and future smokers did not differ in baseline stress levels or in their perception of coping properties of smoking. However, abstainers recorded a significantly larger decrease in perceived stress than continuing smokers, and the result held when possible confounding factors were controlled for (P0.001).In highly dependent smokers who report that smoking helps them cope with stress, smoking cessation is associated with lowering of stress. Whatever immediate effects smoking may have on perceived stress, overall it may generate or aggravate negative emotional states. The results provide reassurance to smokers worried that stopping smoking may deprive them of a valuable coping resource.

To determine effects on craving, user satisfaction, and consumption patterns of two new nicotine replacement therapies (NRT) used for eight hours after overnight tobacco abstinence.In a within-subject, cross-over trial participants were randomly assigned Zonnic nicotine mouth spray (1 mg/spray), Zonnic nicotine lozenge (2.5 mg), Nicorette gum (4 mg) and placebo lozenge on each of four study days.University research unit.Forty-seven dependent adult smokers.Participants rated their urges to smoke, irritability, concentration and restlessness before and during the first hour of product use on a 100-point scale. A subsample of 11 participants provided blood samples for nicotine analysis.All active products reduced craving significantly more than placebo (mean reductions of 28.6, 25.8, 24.7 and 8.9 points for mouth spray, gum, lozenge and placebo). Mouth spray relieved craving faster than placebo and gum with significant reductions within five minutes of use (mean differences of -14.5 (95% CI: -23.0 to -6.0) and -10.6 (95% CI: -19.1 to -2.1) with placebo and gum respectively. Mouth spray produced a faster time to maximum plasma nicotine concentration (14.5 minutes, 95% CI: 8.0 to 21.0) compared to the lozenge (30.3 minutes, 95% CI: 21.1 to 39.5) and gum (45.8 minutes, 95% CI: 36.2 to 55.4). Maximum concentrations of blood nicotine were higher with mouth spray (10.0 ng/ml) and lozenge (10.8 ng/ml) compared to gum (7.8 ng/ml). Both lozenge and mouth spray were well tolerated.The mouth spray and lozenge are at least as effective as 4 mg nicotine gum in relieving craving suggesting that they are likely to be effective in aiding smoking cessation. The mouth spray may be particularly useful for acute craving relief.

Aims Recent ex-smokers report a range of reactions to other people's cigarette smoke. We examined the hypothesis that those who find the smell of smoke pleasant and tempting are more likely to relapse than those who have a neutral or even negative reaction to it. Design A total of 1110 consecutive patients who attended for smoking cessation treatment and achieved at least 1 week of validated abstinence provided weekly ratings of their reactions to other people's cigarette smoke together with routine baseline measures and weekly ratings of withdrawal discomfort [measured on the Mood and Physical Symptom Scale (MPPS)]. Findings Twenty-three per cent of the sample found the smell of other people's cigarette smoke during their first week of abstinence pleasant, and 54% found it tempting. There was only a modest correlation between the two variables. Finding the smoke pleasant was not related to smoking status in the following week, but finding the smoke tempting predicted relapse. Ratings of temptation were related to the severity of withdrawal discomfort and to dependence. Entering MPPS ratings of urges to smoke in the given week into regression analysis resulted in the general urges to smoke, rather than urges elicited by other people's smoke, becoming a significant predictor of smoking status in the following week. In patients who maintained continuous abstinence throughout 4 weeks of treatment the pleasantness ratings remained stable, while the ratings of temptation steadily decreased. Conclusions In abstaining smokers, the like or dislike of other people's smoke is not related to relapse. The temptation to smoke elicited by other people's smoke is related to outcome, but only as an indicator of a general ‘temptation threshold’. Patients who find other people's smoke tempting can be reassured that this reaction will gradually decrease.

Context Rapid smoking (RS) is a smoking cessation technique with sufficient indications of promise to warrant further investigation. The main presumed effect of RS is on reducing desire to smoke. Aim To evaluate the effect of a single session of RS immediately prior to quitting smoking on urges to smoke over the first week of abstinence. Design Randomized controlled trial. Setting Specialist smoking cessation clinic (SSCC). Participants A total of 100 smokers attending the quit day session. Intervention Participants in the rapid smoking group underwent a single session of RS immediately prior to quitting smoking. Participants in the control group watched a health promotion video on giving up smoking. Primary outcome measures Ratings of urges to smoke in the first 24 hours and 1 week of abstinence. Findings The RS procedure was well tolerated. It led to significantly lower urges to smoke compared to the control procedure during the first 24 hours (mean rating of 2.6 versus 3.2, P

Constipation is mentioned occasionally as a possible tobacco withdrawal symptom, but no systematic data have been published on this issue.Smokers' clinic patients provided ratings of their level of constipation on three occasions prior to their quit date, and then weekly after they stopped smoking. The total of 1067 participants maintained at least 1 week of continuous abstinence and provided usable data.The three precessation ratings of constipation were stable. After cessation of smoking, the ratings increased significantly (P0.01). In 514 patients who maintained continuous abstinence for 4 weeks and provided complete data, constipation peaked at 2 weeks but remained elevated over the whole period. The net proportion of patients affected was 17%, including 9% who were symptom-free at baseline and became very or extremely constipated. In patients on nicotine replacement the increase in constipation, although significant, was less than in patients on bupropion.Clinicians treating smokers need to be aware of a possibility that one in six quitters develop constipation, and that for about one in 11 the problem can be severe. Descriptions of tobacco withdrawal syndrome should include constipation.

The causal relationship between cigarette smoking and cardiovascular disease (CVD) is well known and it is of great importance that smokers with CVD are encouraged to stop. Nicotine replacement therapy (NRT) is an effective aid to smoking cessation. However, its use in patients with CVD is often avoided because of warnings on product labelling. This is not justified, as NRT use in dependent smokers is much safer than smoking. Arguments are presented for the following guidelines which may be used when recommending NRT to patients with CVD; (i) NRT can normally be recommended to smokers with CVD who tried and failed to quit without such help; (ii) in patients who have experienced a serious cardiovascular event within the past 4 weeks, involve the patient's consulting physician. In less acute cases this is not needed; (iii) ensure dosing does not exceed the manufacturer's recommendation; (iv) warn patients to stop using NRT if they relapse to smoking; and (v) target motivated smokers (i.e. those seeking help), and where possible provide or arrange intensive behavioural support to accompany NRT. This advice is conservative, but will hopefully remove some obstacles faced by smoking cessation counsellors and other health professionals when considering the use of NRT in people with history of CVD.