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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02521662
Registration number
NCT02521662
Ethics application status
Date submitted
9/08/2015
Date registered
13/08/2015
Date last updated
19/08/2021
Titles & IDs
Public title
The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking Cessation
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Scientific title
A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence
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Secondary ID [1]
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U1111-1172-9632
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Universal Trial Number (UTN)
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Trial acronym
ASCEND-II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nicotine patch
Treatment: Devices - e-cigarette
Treatment: Drugs - Nicotine
Behaviour - Behavioural support
Active Comparator: Patch - 21mg nicotine patch daily for 14 weeks (including a 2 week prequit period) plus behavioural support for six weeks post-quit
Active Comparator: Patch and nicotine-free e-cigarette - 21mg nicotine patch (daily) and nicotine-free e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
Active Comparator: Patch and nicotine e-cigarette - 21mg nicotine patch (daily) and nicotine e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
Treatment: Drugs: Nicotine patch
A transdermal patch that slowly releases nicotine into the body through the skin.
Treatment: Devices: e-cigarette
A electronically powered device that delivers to the user an aerosol of propylene glycol and/or glycerine, with or without flavourings and nicotine.
Treatment: Drugs: Nicotine
Nicotine contained in e-liquid (e-juice) used in e-cigarettes
Behaviour: Behavioural support
Withdrawal-oriented behavioural support
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Intervention code [3]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Continuous abstinence (Russell Standard)
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Assessment method [1]
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Self-report of smoking not more than five cigarettes from the Quit date, supported by biochemical validation (expired air carbon monoxide).
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Timepoint [1]
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Six months post quit date
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Secondary outcome [1]
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Continuous abstinence
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Assessment method [1]
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Self-report of smoking not more than five cigarettes from the Quit date
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Timepoint [1]
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One, three and 12 months post quit date
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Secondary outcome [2]
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7-day point prevalence abstinence
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Assessment method [2]
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Self-report of having smoked no cigarettes (not even a puff) in the past seven days, with biochemical verification at six months only
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Timepoint [2]
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Participant's set quit date, then one, three, six and 12 months post quit date
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Secondary outcome [3]
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Number of cigarettes smoked
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Assessment method [3]
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Self-report of number of cigarettes smoked per day (or when smoking for non-daily smokers)
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Timepoint [3]
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Participant's set quit date, then one, three, six and 12 months post quit date
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Secondary outcome [4]
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Smoking reduction
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Assessment method [4]
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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.
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Timepoint [4]
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Participant's set quit date, then one, three, six and 12 months post quit date
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Secondary outcome [5]
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Time to relapse
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Assessment method [5]
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Time to relapse back to daily smoking from quit date
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Timepoint [5]
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One, three, and six months post quit date
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Secondary outcome [6]
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Withdrawal
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Assessment method [6]
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The physical signs and symptoms associated with withdrawal, measured using the Mood and Physical Symptoms Scale (MPSS).
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Timepoint [6]
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Participant's set quit date, then at one month post quit date
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Secondary outcome [7]
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Self-efficacy
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Assessment method [7]
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Self-rated chances of quitting, measured on a scale of 1-5 where 1=very low and 5=very high
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Timepoint [7]
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Participant's set quit date
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Secondary outcome [8]
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Use of any other smoking cessation methods/products
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Assessment method [8]
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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.
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Timepoint [8]
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Participant's set quit date, then one, three, six and 12 months post quit date
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Secondary outcome [9]
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Serious adverse events
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Assessment method [9]
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Timepoint [9]
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Participant's set quit date, then one, three, six and 12 months post quit date
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Secondary outcome [10]
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Cost
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Assessment method [10]
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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.
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Timepoint [10]
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Participant's set quit date, then one, three, six and 12 months post quit date
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Secondary outcome [11]
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Medication compliance
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Assessment method [11]
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How frequently they used their allocated product
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Timepoint [11]
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Participant's set quit date, then one and three months post quit date
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Secondary outcome [12]
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Crossover
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Assessment method [12]
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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.
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Timepoint [12]
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Participant's set quit date, then one, three, six and 12 months post quit date
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Secondary outcome [13]
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Additional e-cigarette support
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Assessment method [13]
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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.
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Timepoint [13]
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Participant's set quit date, then one, three, six and 12 months post quit date
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Secondary outcome [14]
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Dual use
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Assessment method [14]
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Defined as use of both allocated treatment and continued smoking of cigarettes
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Timepoint [14]
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Participant's set quit date, then one, three, six and 12 months post quit date
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Secondary outcome [15]
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Continuation of treatment use
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Assessment method [15]
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Defined as continued use of allocated treatment after the end of the designated treatment period (12 weeks post-quit).
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Timepoint [15]
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Six and 12 months post quit date
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Secondary outcome [16]
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Perception of their allocated product(s)
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Assessment method [16]
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Participants will be asked what they liked and disliked about their allocated products (free text)
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Timepoint [16]
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Participant's set quit date, then one and three months post quit date
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Secondary outcome [17]
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Recommendations
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Assessment method [17]
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Participant's will be asked whether they would recommend their allocated treatment to another smoker who wanted to quit (Yes/No)
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Timepoint [17]
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Participant's set quit date, then one and three months post quit date
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Eligibility
Key inclusion criteria
- Smoke and want to quit in the next three months
- Reside in New Zealand
- At least 18 years of age
- Able to provide verbal consent
- Have access to telephone (mobile and/or landline)
- Are prepared to use a nicotine patch or a nicotine patch and e-cigarette together.
- Only one person per household is eligible.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Pregnant women
- Women who are breastfeeding
- Current users of NRT products
- People currently enrolled in another smoking cessation programme or other cessation
study
- People who have used an e-cigarette for more than one week in the last year for
smoking cessation
- Current users of non-nicotine based cessation therapies (e.g. buproprion, clonidine,
nortriptyline or varenicline).
- People who have had a heart attack, stroke or severe angina within the previous two
weeks.
- People who self-report a history of severe allergies and/or poorly controlled asthma.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2018
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Sample size
Target
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Accrual to date
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Final
1124
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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North Island
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Health New Zealand Ltd, Christchurch, New Zealand
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Auckland District Health Board
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02521662
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Trial related presentations / publications
Walker N, Verbiest M, Kurdziel T, Laking G, Laugesen M, Parag V, Bullen C. Effectiveness and safety of nicotine patches combined with e-cigarettes (with and without nicotine) for smoking cessation: study protocol for a randomised controlled trial. BMJ Open. 2019 Feb 25;9(2):e023659. doi: 10.1136/bmjopen-2018-023659.
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Public notes
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Contacts
Principal investigator
Name
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Natalie Walker, PhD
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Address
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National Institute for Health Innovation, School of Population Health, University of Auckland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02521662
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