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

BackgroundTobacco 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)

A qualitative study of using nicotine products for smoking cessation after discharge from residential drug and alcohol treatment in Australia

“…Information could be provided on how to achieve nicotine reduction over time, which may be a goal for some clients, particularly as NVPs are commonly used for smoking cessation. Participants in the parent trial received one NVP training session while still in treatment [11] but providing 'vape-taper' guidance and behavioural support following discharge from treatment is a necessary consideration.…”

“…We conducted semi‐structured telephone interviews of trial participants following a 12‐week smoking cessation treatment. The trial protocol [11] is notified with the Therapeutic Goods Administration, and registered with the Australia and New Zealand Clinical Trials Registry (ACTRN 12619001787178). In short, the cNRT condition participants received a 12‐week supply of patches (21 mg/24 h) combined with the choice of nicotine gum or inhalator [11], mailed in three 4‐week batches.…”

“…Participants were selected for qualitative interviews based on cessation method allocated to in the parent trial, gender and study site to ensure sample diversity. These selected participants were invited to complete a phone interview about their experience of using either cNRT or NVP for tobacco smoking cessation after 12‐week follow‐up for the parent trial [11]. A maximum of three call attempts were made, with no repeat interviews, and no participation incentives.…”

“…The trial protocol [11] is notified with the Therapeutic Goods Administration, and registered with the Australia and New Zealand Clinical Trials Registry (ACTRN 12619001787178). In short, the cNRT condition participants received a 12-week supply of patches (21 mg/24 h) combined with the choice of nicotine gum or inhalator [11], mailed in three 4-week batches. The NVP condition participants received a refillable NVP (Innokin ® Endura T18-II), with unflavoured nicotine e-liquid in a vegetable glycerol base (Nicophar ® 1.2%, 12 mg/10 mL) mailed in three 4-week batches.…”

“…NVPs are small battery-powered devices that heat a coil to aerosolise liquid for inhalation, typically comprising propylene glycol, glycerol, water and freebase or salt nicotine, with or without flavourings. NVP product designs are evolving over time, from refillable tank [7][8][9][10][11][12], to pod-style devices [13] and clinical studies of their therapeutic applications typically use current designs.…”