Objectives To measure the short-term effects of an electronic nicotine delivery device (“e cigarette”, ENDD) on desire to smoke, withdrawal symptoms, acceptability, pharmacokinetic properties and adverse effects. Design Single blind randomised repeated measures cross-over trial of the Ruyan V8 ENDD. Setting University research centre in Auckland, New Zealand. Participants 40 adult dependent smokers of 10 or more cigarettes per day. Interventions Participants were randomised to use ENDDs containing 16 mg nicotine or 0 mg capsules, Nicorette nicotine inhalator or their usual cigarette on each of four study days 3 days apart, with overnight smoking abstinence before use of each product. Main outcome measures The primary outcome was change in desire to smoke, measured as “area under the curve” on an 11-point visual analogue scale before and at intervals over 1 h of use. Secondary outcomes included withdrawal symptoms, acceptability and adverse events. In nine participants, serum nicotine levels were also measured. Results Over 60 min, participants using 16 mg ENDD recorded 0.82 units less desire to smoke than the placebo ENDD (p=0.006). No difference in desire to smoke was found between 16 mg ENDD and inhalator. ENDDs were more pleasant to use than inhalator (p=0.016) and produced less irritation of mouth and throat (p<0.001). On average, the ENDD increased serum nicotine to a peak of 1.3 mg/ml in 19.6 min, the inhalator to 2.1 ng/ml in 32 min and cigarettes to 13.4 ng/ml in 14.3 min. Conclusions The 16 mg Ruyan V8 ENDD alleviated desire to smoke after overnight abstinence, was well tolerated and had a pharmacokinetic profile more like the Nicorette inhalator than a tobacco cigarette. Evaluation of the ENDD for longer-term safety, potential for long-term use and efficacy as a cessation aid is needed. Trial registration No.12607000587404, Australia and New Zealand Clinical Trials Register
18 December 2014 in New England Journal of Medicine
Placebo-controlled trials indicate that cytisine, a partial agonist that binds the nicotinic acetylcholine receptor and is used for smoking cessation, almost doubles the chances of quitting at 6 months. We investigated whether cytisine was at least as effective as nicotine-replacement therapy in helping smokers to quit.
Background: The New Zealand 2003 Smoke-free Environments Amendment Act (SEAA) extended existing restrictions on smoking in office and retail workplaces by introducing smoking bans in bars, casinos, members’ clubs, restaurants and nearly all other workplaces from 10 December 2004. Objective: To evaluate the implementation and outcomes of aspects of the SEAA relating to smoke-free indoor workplaces and public places, excluding schools and early learning centres. Methods: Data were gathered on public and stakeholder attitudes and support for smoke-free policies; dissemination of information, enforcement activities and compliance; exposure to secondhand smoke (SHS) in the workplace; changes in health outcomes linked to SHS exposure; exposure to SHS in homes; smoking prevalence and smoking related behaviours; and economic impacts. Results: Surveys suggested growing majority support for the SEAA and its underlying principles among the public and bar managers. There was evidence of high compliance in bars and pubs, where most enforcement problems were expected. Self reported data suggested that SHS exposure in the workplace, the primary objective of the SEAA, decreased significantly from around 20% in 2003, to 8% in 2006. Air quality improved greatly in hospitality venues. Reported SHS exposure in homes also reduced significantly. There was no clear evidence of a short term effect on health or on adult smoking prevalence, although calls to the smoking cessation quitline increased despite reduced expenditure on smoking cessation advertising. Available data suggested a broadly neutral economic impact, including in the tourist and hospitality sectors. Conclusion: The effects of the legislation change were favourable from a public health perspective. Areas for further investigation and possible regulation were identified such as SHS related pollution in semi-enclosed outdoor areas. The study adds to a growing body of literature documenting the positive impact of comprehensive smoke-free legislation. The scientific and public health case for introducing comprehensive smoke-free legislation that covers all indoor public places and workplaces is now overwhelming, and should be a public health priority for legislators across the world as part of the globalisation of effective public health policy to control the tobacco epidemic.
Issue: Many randomized controlled trials (RCTs) are conducted each year but only a small proportion is specifically designed for Indigenous people. In this review we consider the challenges of participation in RCTs for Indigenous peoples from New Zealand, Australia, Canada and the United States and the opportunities for increasing participation. Approach: The literature was systematically searched for published articles including information on the barriers and facilitators for Indigenous people’s participation in health-related RCTs. Articles were identified using a key word search of electronic databases (Scopus, Medline and EMBASE). To be included, papers had to include in their published work at least one aspect of their RCT that was either a barrier and/or facilitator for participation identified from, for example, design of intervention, or discussion sections of articles. Articles that were reviews, discussions, opinion pieces or rationale/methodology were excluded. Results were analysed inductively, allowing themes to emerge from the data. Key findings: Facilitators enabling Indigenous people’s participation in RCTs included relationship and partnership building, employing Indigenous staff, drawing on Indigenous knowledge models, targeted recruitment techniques and adapting study material. Challenges for participation included both participant-level factors (such as a distrust of research) and RCT-level factors (including inadequately addressing likely participant barriers (phone availability, travel costs), and a lack of recognition or incorporation of Indigenous knowledge systems. Implication: The findings from our review add to the body of knowledge on elimination of health disparities, by identifying effective and practical strategies for conducting and engaging Indigenous peoples with RCTs. Future trials that seek to benefit Indigenous peoples should actively involve Indigenous research partners, and respect and draw on pertinent Indigenous knowledge and values. This review has the potential to assist in the design of such studies.
Roll-your-own (RYO) cigarettes have increased in popularity, yet their comparative potential toxicity is uncertain. This study compares smoking of RYO and factory-made (FM) cigarettes on smoking pattern and immediate potential toxicity.