None listed
Conditions
Brief summary
This pragmatic, open-label randomised partial cross-over trial aims to evaluate if adding a nicotine maintenance intervention (a nicotine vaporiser, 3 months of refill fluid at no cost and additional refill fluid at cost until final follow-up at 24 months) to standard quit support intervention (a 3 month course of cessation pharmacotherapy at no cost, self-help materials and active referral to Quitline) improves quit rates for people with priority medical conditions and whether offering both interventions concurrently (Condition A: both interventions used started at the same time) is more effective and cost-effective than offering the interventions sequentially (Condition B: only standard quit support offered at baseline and nicotine maintenance intervention only offered to those who are not abstinent at 6 months). Hypotheses: Condition A will have a higher rate of 3 months continuous abstinence compared to Condition B at 6 months (H1) and 12 months (H2) and lower relapse rates at 6, 12 and 24 months (H3). Condition A will be more cost-effective than Condition B at 6 months (H4) and 12 months (H5). Outcomes/significance: Smoking is a leading cause of preventable death for people with priority medical conditions due to their high smoking prevalence, greater vulnerability to tobacco-related disease and low quit rates with current cessation therapies. Our study will provide evidence on the effectiveness, safety and cost-effectiveness of offering nicotine maintenance in addition to standard cessation treatment to people living with comorbidities.
Interventions
ARM 1: Standard quit support in the form of referral to Quitline telephone smoking cessation counselling + Nicotine patches (15mg/16hr) delivered at baseline. Arm 1 participants will also receive at baseline a nicotine vaporiser intervention in the form of a refillable nicotine vaporiser device (2 x kits) + nicotine vaporising liquid (in high and low strength - high strength: nicotine 1.8% in Vegetable Glycerine and purified water; low strength: nicotine 0.6% in Vegetable Glycerine and purifie
ARM 1: Standard quit support in the form of referral to Quitline telephone smoking cessation counselling + Nicotine patches (15mg/16hr) delivered at baseline. Arm 1 participants will also receive at baseline a nicotine vaporiser intervention in the form of a refillable nicotine vaporiser device (2 x kits) + nicotine vaporising liquid (in high and low strength - high strength: nicotine 1.8% in Vegetable Glycerine and purified water; low strength: nicotine 0.6% in Vegetable Glycerine and purified water). One patch to be applied daily to skin for up to 84 days. The vaporiser with nicotine liquid is to be used as needed up to 3.5mL per day to treat withdrawal symptoms for up to 2 years (concurrently with patches for the first 84 days) to assist smoking cessation and relapse prevention. Participants start on high strength nicotine liquid and may decrease their dose to low strength to assist with dose reduction prior to stopping use of the vaporiser. Arm 2: Standard quit support in the form of referral to Quitline telephone smoking cessation counselling + Nicotine patches (15mg/16hr) + participant’s choice of either nicotine gum or nicotine lozenges (up to 800 x 4mg pieces to be used up to 8 per day) delivered at baseline. Between 6-9 months post baseline - participants in Arm 2 who are smoking (either failed to quit or relapsed) will be offered the nicotine vaporiser intervention in the form of: refillable nicotine vaporiser (2 x kits) + nicotine vaporising liquid (in high and low strength - high strength: nicotine 1.8% in Vegetable Glycerine and purified water; low strength: nicotine 0.6% in Vegetable Glycerine and purified water) to make a second quit attempt. Participants start on high strength nicotine liquid and may decrease their dose to low strength to assist with dose reduction prior to stopping use of the vaporiser at the discretion of the participant. Participants will have until 2 years from baseline to use the vaporiser for smoking cessation and relapse prevention. Use of the intervention will be monitored through self-report via surveys which will be administered online and by telephone.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Diagnosed with or receiving treatment for a priority health conditions in the past 12 months; 2) Aged 18+ years; 3) Currently smoke 10+ cigarettes per day; 4) Has capacity to consent, able to understand participant materials and follow study instructions and comply with study procedures (e.g. sufficient English language ability, able to operate the vaporiser device); 5) Willing to make a quit attempt at baseline according to randomised condition (Condition A to make quit attempt with nicotine vaporiser; Condition B to make quit attempt without nicotine vaporiser); 6) Has a referral to Quitline counselling and smoking cessation support program (standard care) but has not commenced quit attempt (Note: Quitline referral can occur at time of study enrolment).
Exclusion criteria
1) Already commenced quit attempt (i.e. post quit day) at time of enrolment into trial or currently enrolled in another smoking cessation clinical trial or using varenicline or bupropion or used a nicotine vaporiser product in the last 30 days. NOTE: Use of nicotine replacement products not supplied in the trial (e.g. as part of quitline support) is not an exclusion criteria. 2) Currently pregnant and/or breast-feeding or an intention to be during trial participation period; i) A urinary pregnancy test will be required where pregnancy is suspected; ii) Participants will be advised appropriate contraception should be used to avoid pregnancy during the trial with on-going contraception options discussed; 3) Has experienced cardiac related chest pain, or another cardiovascular event or procedure in the last month such as heart attack, stroke, insertion of stent, bypass surgery; 4) Hospitalised for a mental health condition in the last 30 days; 5) Currently being treated with oxygen therapy; 6) Diagnosed terminal illness (such as cancer) or debilitating condition that will limit ability to fully participate as determined by pre-registration responses from participant or opinion of enrolling clinician.
Outcome results
None listed