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Trial registered on ANZCTR


Registration number
ACTRN12617000849392
Ethics application status
Approved
Date submitted
1/06/2017
Date registered
8/06/2017
Date last updated
15/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The QuitNic Study: A pilot study of electronic nicotine devices for smoking cessation with drug and alcohol clients
Scientific title
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
Secondary ID [1] 290963 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 301705 0
Alcohol and other drug use 301706 0
Condition category
Condition code
Public Health 301404 301404 0 0
Other public health
Mental Health 302984 302984 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 296910 0
Treatment: Drugs
Intervention code [2] 296911 0
Treatment: Devices
Intervention code [3] 298288 0
Behaviour
Comparator / control treatment
Group 2: Current Best Practice Cessation Support (combination NRT + Quitline)
Participants randomised to Group 2 will receive the following:
* An information pack that includes printed information on benefits of quitting (including benefits on AOD reduction), and instructions on how to use NRT correctly, for how long, potential side effects (and when to notify a health care provider), safe storage and handling.
* Provision of 12 weeks of nicotine replacement therapy (patches and either inhalators, gum or lozenges). Participants in this group will initially receive 4 weeks supply of patches plus their choice of either gum or inhalator or lozenge, and will be asked for a mailing address so that the remainder can be mailed out to them on two further occasions (3 x 4 weeks supplies);
* Proactive referral to Quitline counselling (call-back service) which provides calls on days 1, 3, 7, 14 & 28 post-discharge, with an emphasis on relapse prevention. At least one call will additionally be conducted during the stay at the AOD treatment facility pre-discharge. 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 to alert them to expect a quitline call prior to being called as AOD clients are unlikely to pick up calls from a private number. Counsellors will monitor and encourage correct use of NRT and work with clients to address barriers to its use.
Standard Smoking Cessation Pharmacotherapy
Participants randomised to Group 2 (NRT + Quitline support) will receive both a transdermal and oromucosal form of NRT to be used throughout the treatment period. Participants randomised to the Group 1 (ENDs + Quitline support) will receive only a 1-week supply of transdermal NRT (patch). These products include;
* Patch (Transdermal; 21mg)
* Gum (Oromucosal; 4 mg)
* Lozenge (Oromucosal; 4mg)
*Inhalator (Oromucosal; 15mg per cartridge)
Control group
Active

Outcomes
Primary outcome [1] 300802 0
7-day point prevalence (and duration of abstinence)

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?”

Timepoint [1] 300802 0
At baseline, and at 6 weeks and 12 weeks post discharge
Primary outcome [2] 300803 0
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?”
Timepoint [2] 300803 0
At 6 weeks and 12 weeks post discharge
Secondary outcome [1] 330892 0
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.
Timepoint [1] 330892 0
At 6 weeks and 12 weeks post discharge
Secondary outcome [2] 330893 0
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.
Timepoint [2] 330893 0
At 6 weeks and 12 weeks post discharge
Secondary outcome [3] 330894 0
Continuous abstinence from all nicotine (including NRT and ENDs) assessed by survey at 12 week time point.
Timepoint [3] 330894 0
At 6 weeks and 12 weeks post discharge
Secondary outcome [4] 330895 0
Cigarettes smoked per day assessed by questionnaire item designed for this study asked at 6 and 12 week time points.
Timepoint [4] 330895 0
At 6 weeks and 12 weeks post discharge
Secondary outcome [5] 330896 0
This a composite secondary outcome. Cravings and withdrawal will be assessed by a standardized scale (Minnesota Nicotine Withdrawal Scale)
Timepoint [5] 330896 0
At 6 weeks and 12 weeks post discharge
Secondary outcome [6] 330897 0
Time to relapse assessed by questionnaire item designed for this study.
Timepoint [6] 330897 0
At 6 weeks and 12 weeks post discharge
Secondary outcome [7] 330898 0
Treatment adherence (use of NRT, ENDs and Quitline) assessed by questionnaire items designed for this study.
Timepoint [7] 330898 0
At 6 weeks and 12 weeks post discharge
Secondary outcome [8] 330899 0
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.
Timepoint [8] 330899 0
At 6 weeks and 12 weeks post discharge
Secondary outcome [9] 330900 0
Process measures: (records from Quitline database regarding number, length, content and timing of calls will be collected)
Timepoint [9] 330900 0
At 12 weeks post discharge

Eligibility
Key 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)
- 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be invited to participate only if they meet all of the inclusion criteria and none of the exclusion criteria.
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised on a 1:1 ratio to one of the two intervention groups using computer sequenced block randomisation. At the end of the baseline survey participants will be randomized to an intervention condition via a computer sequenced block randomisation embedded in the iPad.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised on a 1:1 ratio to one of the two intervention groups using computer sequenced block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample Size Estimation
We expect to recruit 150 clients over a 16 month period which is achievable in the withdrawal unit which sees over 620 clients a year. Approximately 80% of Turning Point clients are smokers. We will be assuming 50% eligibility and consent into the trial, and 40% attrition at 12 weeks based on our current AOD research and thus approaching 400 service clients over the 16-month recruitment period. A total sample of 100 participants at 12 week follow-up will provide 50 smokers per experimental group. This pilot trial has been designed to provide essential information for the development of an adequately powered larger superiority trial, including smoking prevalence, response and attrition rates.

Statistical Analysis Plan
Data will be collected on recruitment and retention rates which will aid the design of future large trials. Primary cessation outcome analyses will be carried out on an intention to treat basis. Chi squared tests, relative risks and 95% CIs and 2-sided p-values for all binary variables, followed by adjusted multiple logistic regression analyses. Continuous outcomes (with 95% CIs) will be analysed using generalised linear mixed methods regression for the main aims, with adjustments for covariates where necessary.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7348 0
Turning Point Drug and Alcohol Centre - Fitzroy
Recruitment postcode(s) [1] 15139 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 295382 0
Government body
Name [1] 295382 0
Victorian Health Promotion Foundation (VicHealth)
Address [1] 295382 0
Ground Floor, 15-31 Pelham Street
Carlton VIC 3053
Country [1] 295382 0
Australia
Primary sponsor type
University
Name
The University of Newcastle, NSW
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 294205 0
None
Name [1] 294205 0
Address [1] 294205 0
Country [1] 294205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296717 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 296717 0
Eastern Health, Level 4
5 Arnold St
Box Hill VIC 3128
Ethics committee country [1] 296717 0
Australia
Date submitted for ethics approval [1] 296717 0
17/10/2016
Approval date [1] 296717 0
29/03/2017
Ethics approval number [1] 296717 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71850 0
Prof Billie Bonevski
Address 71850 0
School of Medicine & Public Health
Faculty of Health & Medicine
The University of Newcastle
University Drive
Callaghan NSW 2308

Country 71850 0
Australia
Phone 71850 0
+61 2 4033 5710
Fax 71850 0
+61 2 4033 5692
Email 71850 0
billie.bonevski@newcastle.edu.au
Contact person for public queries
Name 71851 0
Dr Ashleigh Guillaumier
Address 71851 0
School of Medicine & Public Health
Faculty of Health & Medicine
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 71851 0
Australia
Phone 71851 0
+61 2 4033 5718
Fax 71851 0
+61 2 4033 5692
Email 71851 0
ashleigh.guillaumier@newcastle.edu.au
Contact person for scientific queries
Name 71852 0
Prof Billie Bonevski
Address 71852 0
School of Medicine & Public Health
Faculty of Health & Medicine
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 71852 0
Australia
Phone 71852 0
+61 2 4033 5710
Fax 71852 0
+61 2 4033 5692
Email 71852 0
billie.bonevski@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
No Results