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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02521662




Registration number
NCT02521662
Ethics application status
Date submitted
9/08/2015
Date registered
13/08/2015

Titles & IDs
Public title
The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking Cessation
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
Secondary ID [1] 0 0
U1111-1172-9632
Universal Trial Number (UTN)
Trial acronym
ASCEND-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nicotine patch
Treatment: Devices - e-cigarette
Treatment: Drugs - Nicotine
BEHAVIORAL - 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

BEHAVIORAL: Behavioural support
Withdrawal-oriented behavioural support
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Intervention code [3] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Continuous abstinence (Russell Standard)
Timepoint [1] 0 0
Six months post quit date
Secondary outcome [1] 0 0
Continuous abstinence
Timepoint [1] 0 0
One, three and 12 months post quit date
Secondary outcome [2] 0 0
7-day point prevalence abstinence
Timepoint [2] 0 0
Participant's set quit date, then one, three, six and 12 months post quit date
Secondary outcome [3] 0 0
Number of cigarettes smoked
Timepoint [3] 0 0
Participant's set quit date, then one, three, six and 12 months post quit date
Secondary outcome [4] 0 0
Smoking reduction
Timepoint [4] 0 0
Participant's set quit date, then one, three, six and 12 months post quit date
Secondary outcome [5] 0 0
Time to relapse
Timepoint [5] 0 0
One, three, and six months post quit date
Secondary outcome [6] 0 0
Withdrawal
Timepoint [6] 0 0
Participant's set quit date, then at one month post quit date
Secondary outcome [7] 0 0
Self-efficacy
Timepoint [7] 0 0
Participant's set quit date
Secondary outcome [8] 0 0
Use of any other smoking cessation methods/products
Timepoint [8] 0 0
Participant's set quit date, then one, three, six and 12 months post quit date
Secondary outcome [9] 0 0
Serious adverse events
Timepoint [9] 0 0
Participant's set quit date, then one, three, six and 12 months post quit date
Secondary outcome [10] 0 0
Cost
Timepoint [10] 0 0
Participant's set quit date, then one, three, six and 12 months post quit date
Secondary outcome [11] 0 0
Medication compliance
Timepoint [11] 0 0
Participant's set quit date, then one and three months post quit date
Secondary outcome [12] 0 0
Crossover
Timepoint [12] 0 0
Participant's set quit date, then one, three, six and 12 months post quit date
Secondary outcome [13] 0 0
Additional e-cigarette support
Timepoint [13] 0 0
Participant's set quit date, then one, three, six and 12 months post quit date
Secondary outcome [14] 0 0
Dual use
Timepoint [14] 0 0
Participant's set quit date, then one, three, six and 12 months post quit date
Secondary outcome [15] 0 0
Continuation of treatment use
Timepoint [15] 0 0
Six and 12 months post quit date
Secondary outcome [16] 0 0
Perception of their allocated product(s)
Timepoint [16] 0 0
Participant's set quit date, then one and three months post quit date
Secondary outcome [17] 0 0
Recommendations
Timepoint [17] 0 0
Participant's set quit date, then one and three months post quit date

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
Accrual to date
Final
1124
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
North Island

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Health New Zealand Ltd, Christchurch, New Zealand
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Auckland District Health Board
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Natalie Walker, PhD
Address 0 0
National Institute for Health Innovation, School of Population Health, University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?


Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Walker N, Parag V, Verbiest M, Laking G, Laugesen ... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02521662