The combined effect of very low nicotine content cigarettes, used as an adjunct to usual Quitline care (nicotine replacement therapy and behavioural support), on smoking cessation: a randomized controlled trial.

AIM: 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. DESIGN: Single-blind, parallel randomized trial. SETTING: 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. MEASUREMENTS: 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. FINDINGS: 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 (P < 0.0001). CONCLUSIONS: Addition of very low nicotine content cigarettes to standard Quitline smoking cessation support may help some smokers to become abstinent.

Does improved access and greater choice of nicotine replacement therapy affect smoking cessation success? Findings from a randomized controlled trial.

AIMS: 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. DESIGN: Single-blind, randomized controlled trial. SETTING: New Zealand. PARTICIPANTS: 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. MEASUREMENTS: 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. FINDINGS: 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, P<0.01) 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%). CONCLUSIONS: 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.

Study protocol for a randomised trial of nicotine-free cigarettes as an adjunct to usual NRT-based cessation practice, in people who wish to stop smoking.

BACKGROUND: Current smoking cessation treatments focus on addressing the pharmacological dependence of smokers on nicotine. However, new strategies are needed that address both nicotine dependence and the psychological dependence on cigarettes as the source of nicotine. Evidence from a number of small smoking cessation studies suggests that the use of cigarettes with reduced nicotine content, in combination with nicotine replacement therapy (NRT), may help reduce withdrawal symptoms and increase quit rates. This paper describes the protocol for a large randomised-controlled trial to test the effect of using nicotine-free cigarettes together with NRT on long-term quit rates. METHODS/DESIGN: This single-blind, randomised trial aims to recruit 1,410 participants through the national telephone-based Quitline service in New Zealand. Participants in the treatment arm will be asked to stop smoking nicotine-containing cigarettes on their chosen Quit day and smoke ad libitum nicotine-free (Quest 3) cigarettes for six weeks. At the same time people in this group will be asked to start using NRT patches, gum and/or lozenges (as recommended by Quitline) for eight weeks. Participants in the control arm will be asked to stop smoking completely on their chosen Quit day and start using NRT patches, gum and/or lozenges (as recommended by Quitline) for eight weeks. Data collection will occur at baseline, three and six weeks, and three and six months after Quit day. The primary outcome is the proportion of participants who self-report seven-day point prevalence abstinence at six months since Quit date. DISCUSSION: Smoking prevalence in New Zealand has changed little in recent years (particularly in Maori, the indigenous people of New Zealand) and additional options for smokers who want to quit are needed. Although a variety of methods are available to help, many are expensive, have side effects, and despite their use most quit attempts still fail. This trial will test the balance of benefits and risks of a new strategy for people to overcome nicotine dependence. Since smoking is the leading cause of lost healthy life years in New Zealand, if proven effective this strategy is likely to have substantial public health benefits.

Pre-cessation nicotine replacement therapy: pragmatic randomized trial.

AIMS: To determine the effectiveness of 2 weeks' pre-cessation nicotine patches and/or gum on smoking abstinence at 6 months. DESIGN: Pragmatic randomized controlled trial. SETTING: New Zealand. PARTICIPANTS: 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. MEASUREMENTS: 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. FINDINGS: 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. CONCLUSIONS: 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.

Characteristics and quitting success of roll-your-own versus tailor-made cigarette smokers.

AIMS: Roll-your-own (RYO) tobacco use is exceptionally high in New Zealand with 61% of current smokers using it exclusively or in conjunction with tailor-made (TM) cigarettes. This study examines the characteristics of RYO users and their likelihood of quitting smoking compared to TM and mixed tobacco users. METHODS: A random sample of Quitline callers with a booster sample of Maori, was invited to participate in a telephone survey three times within a 12-month period. The response rates for the first survey were 57% for Maori and 63% for non-Maori, resulting in a total of 2002 participants. Among these participants, 64% completed the 6-month follow-up and 42% completed the entire study. Two participants were excluded from this analysis as they smoked neither RYO nor TM. We compared the eligible participants' characteristics and quitting outcomes by tobacco type. Quit status was assessed by 7-day abstinence at 6- and 12-month and we used a conservative approach to treat missing cases. RESULTS: RYO use was common among particular smokers such as Maori, male, and low socioeconomic status subjects. When sociodemographic and smoking variables were controlled for using a logistic regression model, quit rates were not different by tobacco type. DISCUSSION: This study confirms the different characteristics of RYO, TM and mixed tobacco users, and fills a gap of limited research about quitting success of RYO smokers.

Response to an indigenous smoking cessation media campaign - it's about whanau.

OBJECTIVE: To assess any effects among Maori (the indigenous people of New Zealand) smokers and their whanau (the traditional Maori family unit) of a campaign designed to support Maori smokers to quit smoking. METHOD: New Zealand-wide cross sectional population surveys between 2000 and 2002 of smokers and whanau pre- and post-airing of the campaign. Measures included recall and awareness of the campaign; perceptions of the campaign; and campaign-attributed changes in quitting-related attitudes and behaviours. RESULTS: Seventy-eight per cent of smokers and 73% of whanau were able to recall the campaign one year following its launch. The television commercials (TVCs) were consistently rated very believable or very relevant by over half of the smokers who had seen them. More than half of smokers (54%) stated that the campaign had made them more likely to quit. CONCLUSION: This nationwide mass media cessation campaign developed to deliver a cessation message to indigenous people was received positively by Maori smokers and their whanau and played a role in prompting quit attempts. IMPLICATIONS: Social marketing campaigns have an important role as part of a tobacco control program to reduce high smoking prevalence among Maori and inequalities in health outcomes between Maori and other New Zealanders.

Under-18 year old callers to New Zealand's Quitline.

AIM: To investigate the characteristics of under-18 year old callers to New Zealand's Quitline (smoking-cessation telephone counselling service). METHODS: Analysis of routinely collected demographic and smoking history characteristics of under-18 year old Quitline callers in 2004 and 2005. RESULTS: In the 24 months of 2004-2005, 2371 under-18s called Quitline (for the first time) seeking smoking cessation support. Females (58.9%) and teens in their older teen years called most often. Compared with adult callers, there were significantly higher proportions of Maori (32.9% vs 19.6%) and Pacific (5% vs 3.6%) under-18 callers, and fewer European (64.0% vs 74.6%) and 'Other' (6.0% vs 7.1%) callers. Despite similar levels of nicotine dependence in under-18 and adult callers (70.1% vs 71.4% reported smoking within 30 minutes of waking), under-18s were issued nicotine replacement therapy (NRT) half as often (RR=0.51). Under-18s were more likely than adults to register a mobile phone number (48.9% vs 44.4%). CONCLUSIONS: Under-18 year old smokers are under-represented in the Quitline calling population. Maori and Pacific under-18s require further cessation support to avoid exacerbating existing disparities in smoking. Awareness that under-18 nicotine dependence is equivalent to that of adults should lead to improved provision of NRT for adolescents. Initiatives involving mobile phone technology are particularly appropriate for improving access to information and treatment for under-18s. Adolescent tobacco cessation should be accorded greater priority in tobacco control policy, practice, and research.

Changes in characteristics of New Zealand Quitline callers between 2001 and 2005.

AIMS: To identify trends in the demographic and smoking characteristics of new callers to the New Zealand Quitline, a national free-phone smoking cessation service, between 2001 and 2005. METHODS: Demographic and smoking behaviour of Quitline callers were routinely collected by Quit Advisors over the phone. Characteristics of new callers were extracted from the client database, and compared across 5 years to determine changes over time. RESULTS: Statistically significant differences were found in all variables (except for gender) across the 5-year period. The results show an increased proportion of callers are under 25 years old (67% increase), started smoking at 15 years old or older (10% increase), and/or have smoked for less than 10 years (86% increase). There is also an increased proportion of callers smoking roll-your-own cigarettes (13% increase). In terms of ethnicity, the proportion of Pacific people using the Quitline increased by 54%, while the proportion of Maori callers fluctuated at just above 20% of all new callers. The proportion of pregnant callers also increased over time (127% increase) although the overall percent remains small. CONCLUSIONS: The results indicate notable changes in the characteristics of new Quitline callers between 2001 and 2005. Such information will be of benefit to the future design of Quitline marketing and adapting service provision to best meet the needs of callers.

A new national smokefree law increased calls to a national quitline.

BACKGROUND: A law making all indoor workplaces including bars and restaurants smokefree became operational in New Zealand in December 2004. New Zealand has a national free-phone Quitline Service which has been operational since 1999. Previous work has shown that the number of calls to the Quitline are influenced by marketing of the service through media campaigns. We set out to investigate if the smokefree law increased calls to the Quitline. METHODS: For 24 months prior to the law, and 12 months after the law, data were collected on: (i) Quitline caller registrations and the issuing of nicotine replacement therapy (NRT) vouchers by the Quitline Service; (ii) expenditure on Quitline-related television advertising; (iii) expenditure on other smokefree television advertising; and (iv) print media coverage of smoking in major New Zealand newspapers. These data were inputs to a time series analysis using a Box-Jenkins transfer function model. This used the law change as the intervention variable, with the response series being the monthly Quitline caller rates and monthly first time NRT voucher issue rates. RESULTS: The monthly rates of Quitline caller registrations and NRT voucher issues were observed to increase in the months after the law change. The increase in both these outcomes was even greater when considered in terms of per level of Quitline advertising expenditure (though these patterns may have partly reflected marked reductions in advertising expenditure at the time of the law change and hence are of limited validity). In the more robust time series analyses, the law change (intervention variable) had a significant effect (p = 0.025) on increasing the monthly caller registration rate in December 2004. This was after adjusting for the possible effects of Quitline advertising expenditure, print media coverage, and other smoking-related advertising expenditure. CONCLUSION: The new national smokefree law resulted in increased quitting-related behaviour. This would suggest there is an extra opportunity for health agencies to promote quitting at such times.