The QuitNic Study: A pilot study of electronic nicotine devices for smoking cessation with drug and alcohol clients
New solutions for reducing harm of tobacco smoking with highly addicted smokers: A pilot study of electronic nicotine devices for smoking cessation with drug and alcohol clients
The University of Newcastle, NSW
100 participants
Jul 31, 2017
Interventional
Conditions
Summary
Smoking prevalence amongst people with alcohol and other drug (AOD) problems is extremely high. In Australia, up to 95% of people entering AOD treatment smoke tobacco, which is five times greater than for the general adult population. Although number of quit attempts are high, sustaining cessation is challenging for people with AOD dependence: many factors related to addiction, lack of cessation support and the high levels of smoking in their social network contribute to high relapse rates in this population. Nicotine Replacement Therapy (NRT) can reduce withdrawal symptoms and cravings and aid cessation, however our research with AOD users indicate they are hesitant to use traditional forms of NRT. Electronic Nicotine Devices (ENDs) hold significant potential as both cessation aids and harm reduction support. Unlike combustible tobacco cigarettes, ENDs deliver nicotine in an inhalable form without the tobacco, hence removing many of the health harms of smoking. This proposal is for a trial aimed at exploring the feasibility, acceptability and potential effectiveness of providing an Electronic Nicotine Device (END) kit, a 12 week supply of liquid nicotine and Quitline support compared with a 12 week supply of combination nicotine replacement therapy and Quitline support to clients upon discharge from an AOD residential withdrawal clinic. The clinic is smoke-free and all clients who smoke tobacco receive NRT while in the program but not following discharge. The trial provides an opportunity to continue cessation support to clients in the community. Specifically, this trial aims to determine whether providing ENDs or combination NRT to AOD clients: assists them to quit smoking following discharge from a smokefree facility, reduces tobacco consumption by at least 50% compared to pre-AOD treatment levels in those who relapse, reduces cigarette (tobacco and/or electronic) cravings and withdrawal symptoms, and demonstrates that ENDs are more acceptable than combination NRT as a quit aid and/or method of harm minimisation. The trial also aims to determine the acceptability of proactive Quitline calls prior to and post discharge from a smoke free AOD facility. A pragmatic pilot randomised trial will be conducted. In addition participants will be asked to provide consent to contact to be possibly be invited at the end of the trial to participate in a one-off qualitative telephone interview to explore participant study experiences.
Eligibility
Inclusion Criteria11
- Client of Wellington House
- Aged 18 years (or over)
- 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.
- Aged under 18 years
- Currently pregnant or breast-feeding women (measured by self-report)
- Insufficient capacity to provide informed consent or complete the study requirements (e.g. completing surveys in English)
- Clients who will be transferred to a long term rehabilitation unit following discharge from Wellington House
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Interventions
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: 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. 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%). 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. Adherence monitoring - We will have a log of Quitline calls, and track unused liquid nicotine return. There will also be safety assessment calls and follow up up surveys in weeks 1, 3, 6 (survey), 7, 10, 12 (survey).
Locations(1)
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ACTRN12617000849392