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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

8/10/2021

Date data sharing statement initially provided

8/10/2021

Date results provided

8/10/2021

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tobacco smoking

Alcohol and other drug use

Condition category

Condition code

Public Health

Other public health

Mental Health

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]

Treatment: Drugs

Intervention code [2]

Treatment: Devices

Intervention code [3]

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]

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]

At baseline, and at 6 weeks and 12 weeks post discharge

Primary outcome [2]

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]