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Smoking CessationPhase 3ASCEND-IINCT02521662

The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking Cessation

A Phase 3 study testing Nicotine patch, e-cigarette and Nicotine in people with Smoking Cessation, run by University of Auckland, New Zealand at 1 site in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Nicotine patch, e-cigarette and Nicotine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,124 participants
Where
1 siteNew Zealand
Study dates
Mar 2016to Aug 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

  • National Institute for Health Innovation, University of Auckland

    Auckland, North Island, 1072

Other trials in New Zealand

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Nicotine patch, e-cigarette, Nicotine, Behavioural support
Keywords
Electronic Cigarettes, Nicotine Patch, Smoking Cessation
Medical subject headings
Smoking Cessation, Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotine patchDrug

    Also called Nicotine replacement therapy

    A transdermal patch that slowly releases nicotine into the body through the skin.

  • e-cigaretteDevice

    Also called electronic cigarette, electronic nicotine delivery device

    A electronically powered device that delivers to the user an aerosol of propylene glycol and/or glycerine, with or without flavourings and nicotine.

  • NicotineDrug

    Also called Nicotine liquid

    Nicotine contained in e-liquid (e-juice) used in e-cigarettes

  • Behavioural supportBehavioural

    Also called Smoking cessation behavioural support

    Withdrawal-oriented behavioural support

Study groups in NCT02521662
Study groupRoleWhat they receive
PatchActive comparator21mg nicotine patch daily for 14 weeks (including a 2 week prequit period) plus behavioural support for six weeks post-quit
Receives: Drug: Nicotine patch; Behavioral: Behavioural support
Patch and nicotine-free e-cigaretteActive comparator21mg 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
Receives: Drug: Nicotine patch; Device: e-cigarette; Behavioral: Behavioural support
Patch and nicotine e-cigaretteActive comparator21mg 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
Receives: Drug: Nicotine patch; Device: e-cigarette; Drug: Nicotine; Behavioral: Behavioural support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Six months post quit date

Secondary outcomes (17)

  1. Continuous abstinence

    Self-report of smoking not more than five cigarettes from the Quit date

    Measured: One, three and 12 months post quit date

  2. 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

    Measured: Participant's set quit date, then one, three, six and 12 months post quit date

  3. Number of cigarettes smoked

    Self-report of number of cigarettes smoked per day (or when smoking for non-daily smokers)

    Measured: Participant's set quit date, then one, three, six and 12 months post quit date

  4. 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.

    Measured: Participant's set quit date, then one, three, six and 12 months post quit date

  5. Time to relapse

    Time to relapse back to daily smoking from quit date

    Measured: One, three, and six months post quit date

  6. Withdrawal

    The physical signs and symptoms associated with withdrawal, measured using the Mood and Physical Symptoms Scale (MPSS).

    Measured: Participant's set quit date, then at one month post quit date

  7. Self-efficacy

    Self-rated chances of quitting, measured on a scale of 1-5 where 1=very low and 5=very high

    Measured: Participant's set quit date

  8. 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.

    Measured: Participant's set quit date, then one, three, six and 12 months post quit date

  9. Serious adverse events

    Measured: Participant's set quit date, then one, three, six and 12 months post quit date

  10. 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.

    Measured: Participant's set quit date, then one, three, six and 12 months post quit date

  11. Medication compliance

    How frequently they used their allocated product

    Measured: Participant's set quit date, then one and three months post quit date

  12. 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.

    Measured: Participant's set quit date, then one, three, six and 12 months post quit date

  13. 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.

    Measured: Participant's set quit date, then one, three, six and 12 months post quit date

  14. Dual use

    Defined as use of both allocated treatment and continued smoking of cigarettes

    Measured: Participant's set quit date, then one, three, six and 12 months post quit date

  15. Continuation of treatment use

    Defined as continued use of allocated treatment after the end of the designated treatment period (12 weeks post-quit).

    Measured: Six and 12 months post quit date

  16. Perception of their allocated product(s)

    Participants will be asked what they liked and disliked about their allocated products (free text)

    Measured: Participant's set quit date, then one and three months post quit date

  17. Recommendations

    Participant's will be asked whether they would recommend their allocated treatment to another smoker who wanted to quit (Yes/No)

    Measured: Participant's set quit date, then one and three months post quit date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2015 (estimated)
  2. Study startMar 2016
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02521662
Sponsor's protocol ID
U1111-1172-9632
Acronym
ASCEND-II
Status last verified
Aug 2021
First submitted
9 Aug 2015
Last updated
19 Aug 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

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.

    PubMed 30808668

  • Walker N, Parag V, Verbiest M, Laking G, Laugesen M, Bullen C. Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial. Lancet Respir Med. 2020 Jan;8(1):54-64. doi: 10.1016/S2213-2600(19)30269-3. Epub 2019 Sep 9.

    PubMed 31515173

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PubMed 39868569

  • Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

    PubMed 34611902

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nicotine patch, e-cigarette and Nicotine in people with Smoking Cessation, run by University of Auckland, New Zealand at 1 site in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous abstinence (Russell Standard) (time frame: Six months post quit date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02521662, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.

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