Feasibility of Electronic Nicotine Devices for Smoking Cessation With Alcohol and Other Drug Treatment Clients

This proposal is for a trial aimed at exploring the feasibility, acceptability and potential effectiveness of the use of electronic nicotine devices (ENDs) as smoking cessation aids when used in conjunction with one of two commonly used quit smoking strategies: 'abrupt cessation' and 'gradual cessation'. Abrupt cessation involves smoking tobacco as normal until a designated quit day, followed by total abstinence. Gradual reduction strategies also involve the designation of a quit day, however smokers utilizing this method aim to reduce or scale their intake of tobacco cigarettes prior to the quit day, usually according to a predefined schedule (i.e. a 25% reduction in tobacco cigarette consumption by week 1). Treatment arms The two intervention conditions: Group 1: Electronic Nicotine Devices abrupt cessation group (ENDs + abrupt) ; Group 2: Electronic Nicotine Devices gradual (ENDs + gradual). Group 1 - Participants in Group 1 (Abrupt Cessation) will be asked to treat that day as their quit day and to start vaping (using their ENDs + liquid nicotine). For the following 12 weeks (treatment period) Group 1 participants will be asked to try and quit smoking cigarettes and replace their cigarettes with use of either, or both of their ENDs products. The devices (Innokin Endura T22 and T18 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. All participants will receive two different models of devices 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. Device: Innokin Endura T22 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. 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. Device: Innokin Endura T18 The Innokin Endura T18 is a slimline, pen style vaporiser. Similar to the Innokin Endura T22, the T18 device requires participants to turn the device on when they wish to use it, and inhale from the end. The liquid nicotine in this device is stored in a smaller 2.5mL tank located directly under the drip tip and can be refilled with additional liquid nicotine as required. The device is powered by a 1000mAh battery which can be recharged using the provided micro USB cable as needed. This device’s slimline design, smaller tank size and shorter battery life may be more appealing to light to moderate smokers interested in a more discrete vaporiser. Liquid nicotine: 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%). Liquid nicotine is designed to be used with an Electronic Nicotine Device (END) 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 (containing the liquid nicotine) is used will depend on the user, and their level of previous tobacco use. One strength of the liquid nicotine will be used (12mg nicotine/ml) which is a concentration that is in common use. The trial will supply in 10 mL pack size (total nicotine per pack =120mg for 1.2%). The strength of the eliquid is similar to a liquid nicotine product currently listed on the Australian Register of Therapeutic Goods, which is approved for over the counter sale in general retail outlets: Nicorette QuickMist Mouthspray, which contains 13.6mg/mL nicotine and each pack contains 13.2mL (i.e total nicotine per pack = 179.5mg nicotine). The trial will supply liquid nicotine for a 12 week period. Adherence will be monitored via safety assessment calls and follow up up surveys in weeks 1, 3, 6 (survey), 7, 10, 12 (survey). We will also track unused liquid nicotine return at the conclusion of the study.