A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.
A pragmatic, double-blind, three-arm randomised controlled trial undertaken in New Zealand to determine whether e-cigarettes combined with nicotine patches can assist smokers in remaining abstinent for at least six months. 1809 smokers who are motivated to quit will be recruited from the community using media advertising and randomly allocated to one of three groups, namely 1) 21mg nicotine patch daily, 2) 21mg nicotine patch daily plus a 'new generation' e-cigarette with no nicotine or 3) 21mg nicotine patch daily plus a 'new generation' e-cigarettes with nicotine. Participants will be instructed to start using the study products two weeks prior to their quit date, and continue for a further 12 weeks after their quit date. Participants will also receive a cessation behavioural support programme consisting of at least six follow-up telephone calls (10-15 minutes each) over the first six weeks. Outcome data will be collected on the participant's set quit date, then one, three, six and (for some but not all) 12 months post-quit date.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,124
A transdermal patch that slowly releases nicotine into the body through the skin.
A electronically powered device that delivers to the user an aerosol of propylene glycol and/or glycerine, with or without flavourings and nicotine.
Nicotine contained in e-liquid (e-juice) used in e-cigarettes
National Institute for Health Innovation, University of Auckland
Auckland, North Island, New Zealand
Continuous abstinence (Russell Standard)
Self-report of smoking not more than five cigarettes from the Quit date, supported by biochemical validation (expired air carbon monoxide).
Time frame: Six months post quit date
Continuous abstinence
Self-report of smoking not more than five cigarettes from the Quit date
Time frame: One, three and 12 months post quit date
7-day point prevalence abstinence
Self-report of having smoked no cigarettes (not even a puff) in the past seven days, with biochemical verification at six months only
Time frame: Participant's set quit date, then one, three, six and 12 months post quit date
Number of cigarettes smoked
Self-report of number of cigarettes smoked per day (or when smoking for non-daily smokers)
Time frame: Participant's set quit date, then one, three, six and 12 months post quit date
Smoking reduction
Defined as reducing consumption by at least 25% (in terms of numbers of cigarettes per day or weight of loose tobacco per day or when smoking for non-daily smokers), at all time points.
Time frame: Participant's set quit date, then one, three, six and 12 months post quit date
Time to relapse
Time to relapse back to daily smoking from quit date
Time frame: One, three, and six months post quit date
Withdrawal
The physical signs and symptoms associated with withdrawal, measured using the Mood and Physical Symptoms Scale (MPSS).
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Withdrawal-oriented behavioural support
Time frame: Participant's set quit date, then at one month post quit date
Self-efficacy
Self-rated chances of quitting, measured on a scale of 1-5 where 1=very low and 5=very high
Time frame: Participant's set quit date
Use of any other smoking cessation methods/products
Participants will be asked whether they used any non-NRT methods of cessation since the last assessment (Yes/No), and if yes, when they started using it, the type they used, and frequency of use.
Time frame: Participant's set quit date, then one, three, six and 12 months post quit date
Serious adverse events
Time frame: Participant's set quit date, then one, three, six and 12 months post quit date
Cost
Cost outcomes will be derived from known costs of the various products include cost per quitter and cost per person reducing their daily cigarette consumption. The tobacco expenditure savings to individual smokers will also be calculated using data on the daily amount smoked prior to quitting and the average price of cigarettes at the time.
Time frame: Participant's set quit date, then one, three, six and 12 months post quit date
Medication compliance
How frequently they used their allocated product
Time frame: Participant's set quit date, then one and three months post quit date
Crossover
Participants in the patch only arm will be asked whether they accessed and used an e-cigarette (with or without nicotine) during the trial (Yes/No) and at what time during the trial.
Time frame: Participant's set quit date, then one, three, six and 12 months post quit date
Additional e-cigarette support
Participants allocated to the e-cigarette groups will be asked whether they accessed any on-line e-cigarette support networks during the trial (Yes/No) and if so what these were (free text), and at what time during the trial.
Time frame: Participant's set quit date, then one, three, six and 12 months post quit date
Dual use
Defined as use of both allocated treatment and continued smoking of cigarettes
Time frame: Participant's set quit date, then one, three, six and 12 months post quit date
Continuation of treatment use
Defined as continued use of allocated treatment after the end of the designated treatment period (12 weeks post-quit).
Time frame: Six and 12 months post quit date
Perception of their allocated product(s)
Participants will be asked what they liked and disliked about their allocated products (free text)
Time frame: Participant's set quit date, then one and three months post quit date
Recommendations
Participant's will be asked whether they would recommend their allocated treatment to another smoker who wanted to quit (Yes/No)
Time frame: Participant's set quit date, then one and three months post quit date