The QuitNic Study: A pilot study of electronic nicotine devices for smoking cessation with drug and alcohol clients

INTERVENTION: The study uses a pragmatic pilot randomised trial design. It is a phase II, open‐label, active control, single‐centre, exploratory trial of the feasibility, acceptability and potential effectiveness of electronic nicotine devices (ENDs) and liquid nicotine use plus Quitline counselling among alcohol and other drug (AOD) clients discharged from care compared to current best practice (Nicotine Replacement Therapy [NRT] and Quitline counselling) for smoking cessation and relapse prevention. Treatment arms The two intervention conditions: Group 1: Electronic Nicotine Devices group (ENDs + Quitline) ‐ [details below]; Group 2: Current Best Practice Cessation Support (combination NRT + Quitline) ‐ [details in 'Comparator/control treatment' section] Group 1: Electronic Nicotine Devices group (ENDs + Quitline) Participants randomised to Group 1 will receive the following: * An information pack diesigned for this study that includes printed information on benefits of quitting (including benefits on AOD reduction) from QuitVic and Cancer Council Victoria; information about nicotine maintenance and benefits of vaping instead of smoking and the risks of vaping compared to complete abstinence; instructions on how to use ENDs and safe storage and handling. * Provision of an END kit (electric nicotine device + charger) + 12 weeks of liquid nicotine along with 1‐week supply of NRT patches (each deliver 21mg over 24 hours). The device (Innokin Endura T22 starter kit) and refill liquid (Nicophar) were selected based on quality assurance and compliance with relevant standards (GMP for liquid). Participants will be provided with the END and an initial 4‐week supply of liquid nicotine, with further supplies of the refill liquid mailed or couriered to them in 4 weekly intervals. Participants will be advised to use both the NRT patches (1 week supplied) and the END for the first week following discharge while they are learning how to use the END effectively. * Proactive referral to Quitline counselling (call‐back service) which provides calls at pre‐discharge and on days 1, 3, 7, 14 & 28 post‐discharge, with an emphasis on relapse prevention. At least one call will additionally be conducted during stay at AOD treatment facility. The total number and timing of calls will be tailored to client need and smoking status, i.e. more frequent calls around relapse crises/quit attempts with an approximate 10 calls over 12 weeks. Participants will be text messaged prior to being called as AOD clients are unlikely to pick up calls from a private number. Counsellors will be provided with training around the use of ENDs monitor and encourage correct use of NRT and work with clients to address barriers to their use. Investigational device and medicine Participants randomised to Group 1 (END + Quitline) will receive one device and a 12‐week supply of one investigational medicine to be used within the trial period. The device is to be used in conjunction with the medicine. Participants will be informed that there is limited data on the long‐term effects of ENDs and liquid nicotine use and therefore are recommended to only use the products provided during the trial and not long‐term. Electronic Nicotine Device: Liquid nicotine: Adherence monitoring ‐ We will have a log of Quitline calls, and track unused liquid nicotine return. There will also be safety assessment cal CONDITION: Alcohol and other drug use Tobacco smoking PRIMARY OUTCOME: 7‐day point prevalence (and duration of abstinence) ; ; ; ; INCLUSION CRITERIA: Individuals will be invited to participate only if they meet all of the inclusion criteria and none of the exclusion criteria. ‐ Client of Wellington House ‐ Aged 18 years (or over) The Innokin Endura T22 is a simple to use device. Participants are required to turn the device on when they wish to use it, and inhale from the mouthpiece (the drip tip). To activate the heating coil to generate aerosol, the user presses and holds down a button while inhaling from the mouthpiece. This process causes the liquid nicotine (stored in the 4mL tank) to be heated by the coil and turned into an aerosol. The tank can be refilled with additional liquid nicotine as required and the 2000mAh battery recharged using a USB cable as needed. Given the large tank size and long battery life, the device does not require to be refilled and recharged as often as other devices, but is larger in size to accommodate these features. A device such as this may therefore be more appealing to heavier smokers. The liquid nicotine will be manufactured to GMP standards for the trial (Nicophar brand). It will be provided to participants in 10ml dropper bottles. The contents of each 10ml bottle will depend on the nicotine strength: 18mg or 12mg strength. Each 12mg strength 10mL bottle will contain nicotine (1.2%), Glycerol (84%) and water (14.8%). Each 18mg strength 10mL bottle will contain nicotine (1.8%), Glycerol (84%) and water (14.2%). The device and the liquid nicotine are designed to be used together ad libitum to reduce/avoid symptoms of withdrawal from tobacco smoking, in a similar way that other fast acting NRT products are used. The frequency with which the device (and the liquid nicotine) is used will depend on the user, and their level of previous tobacco use. ; Standard items will be used to determine the proportion of participants who have not smoked any tobacco in the preceding 7 days: “Have you smoked at least part of a cigarette in the last 7 days?” ; Sustained continuous abstinence from smoking (defined using a modified version of the Russell Standard; no more than five (tobacco) cigarettes from the start of the abstinence period) will be collected at each follow‐up time point; i.e. self‐report at weeks 6 and 12. ; Six and twelve week prolonged abstinence will be measured from discharge to determine the length of sustained cessation. At the subsequent follow‐up, abstinence will be assessed from the prior interview: “Since [date] did you smoke at all, even part of a cigarette?” ‐ Smoked tobacco on entering the Wellington House residential withdrawal unit ‐ Received NRT while in care at Wellington House ‐ Has not used an END containing nicotine in the past month ‐ Has capacity to consent and able to understand the participant materials and follow the study instructions and procedures (e.g. sufficient English language ability). The average stay at Wellington House is seven days, The RA will approach interested clients 3‐6 days post intake, explain the project, provide written participant information sheets and seek written consent. SECONDARY OUTCOME: Cigarettes smoked per day assessed by questionnaire item designed for this study asked at 6 and 12 week time points. Continuous abstinence from all nicotine (including NRT and ENDs) assessed by survey at 12 week time point. Patterns of use of quit assistance (and reasons for discontinuing assistance) assessed by records from the Quitline database regarding number, length, content and timing of calls. In addition to using questionnaire items designed for this study. Point prevalence abstinence from all nicotine (including NRT and ENDs) assessed by survey. Defined as having not used any products containing nicotine in the previous 7 days at assessment. Process measures (Intervention fidelity: assess use of any additional pharmacotherapies, visits to GPs and use of print and online materials) assessed by questionnaire items designed for this study. Process measures: (records from Quitline database regarding number, length, content and timing of calls will be collected) This a composite secondary outcome. Cravings and withdrawal will be assessed by a standardized scale (Minnesota Nicotine Withdrawal Scale) Time to relapse assessed by questionnaire item designed for this study. Treatment adherence (use of NRT, ENDs and Quitline) assessed by questionnaire items designed for this study.