NEAT (NicotinE As Treatment) Trial: Protocol of a randomised controlled trial of vaporised nicotine products compared with nicotine replacement therapy following discharge from residential withdrawal services

Abstract

ABSTRACTBackgroundTobacco smoking rates in alcohol and other drug (AOD) treatment settings is much higher than in the general Australian population. As a result, people seeking treatment for AOD use experience a greater tobacco-related burden of illness. Attempts to reduce smoking rates in AOD treatment consumers have failed to identify smoking cessation strategies with long term effectiveness. The primary aim of this study is to examine the effectiveness of nicotine vaporised products (NVPs) or nicotine replacement therapy (NRT)on self-reported 6 months continuous abstinence at the 9-month follow-up (6 months following end-of 12 weeks of nicotine treatment) for people leaving smoke-free residential withdrawal treatment. Both groups will also receive Quitline telephone counselling. Secondary outcomes and process measures will also be collected.MethodsA two-arm, single-blinded, parallel-group randomised trial with a 6-month post-intervention follow-up (9 months following baseline) will be conducted. The setting is five residential and inpatient government-funded AOD withdrawal units across three cities in three states of Australia (New South Wales, Queensland, Victoria). Participants will be service users aged 18 years or over who smoked at least 10 cigarettes per day, interested in quitting in the next 30 days and have capacity to give informed consent. Research assistants will recruit participants during intake, who then complete a baseline survey, will be randomised to a condition, and receive their first Quitline call during AOD treatment. At discharge, all participants receive a discharge pack containing either NVPs or NRT, depending on condition allocation.DiscussionThis is the first study we know of that will be testing intervening with a tobacco smoking cessation approach during the transition phase from AOD treatment to community. From a public health perspective, this approach has the potential to have tremendous reach into a priority population for smoking cessation.Trial registrationAustralian and New Zealand Clinical Trials Registry (ACTRN12619001787178)