NCT02521662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,124

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

2.4 years

First QC Date

August 9, 2015

Last Update Submit

August 17, 2021

Conditions

Smoking Cessation

Keywords

Electronic CigarettesNicotine PatchSmoking Cessation

Outcome Measures

Primary Outcomes (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).

    Six months post quit date

Secondary Outcomes (17)

  • Continuous abstinence

    One, three and 12 months post quit date

  • 7-day point prevalence abstinence

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

  • Number of cigarettes smoked

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

  • Smoking reduction

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

  • Time to relapse

    One, three, and six months post quit date

  • +12 more secondary outcomes

Study Arms (3)

Patch

ACTIVE COMPARATOR

21mg nicotine patch daily for 14 weeks (including a 2 week prequit period) plus behavioural support for six weeks post-quit

Drug: Nicotine patchBehavioral: Behavioural support

Patch and nicotine-free e-cigarette

ACTIVE COMPARATOR

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

Drug: Nicotine patchDevice: e-cigaretteBehavioral: Behavioural support

Patch and nicotine e-cigarette

ACTIVE COMPARATOR

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

Drug: Nicotine patchDevice: e-cigaretteDrug: NicotineBehavioral: Behavioural support

Interventions

Nicotine patchDRUG

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

Also known as: Nicotine replacement therapy
PatchPatch and nicotine e-cigarettePatch and nicotine-free e-cigarette
e-cigaretteDEVICE

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

Also known as: electronic cigarette, electronic nicotine delivery device
Patch and nicotine e-cigarettePatch and nicotine-free e-cigarette
NicotineDRUG

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

Also known as: Nicotine liquid
Patch and nicotine e-cigarette
Behavioural supportBEHAVIORAL

Withdrawal-oriented behavioural support

Also known as: Smoking cessation behavioural support
PatchPatch and nicotine e-cigarettePatch and nicotine-free e-cigarette

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Health Innovation, University of Auckland

Auckland, North Island, 1072, New Zealand

Location

Related Publications (4)

  • 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.

    PMID: 30808668BACKGROUND

  • 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.

    PMID: 31515173RESULT

  • 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.

    PMID: 39868569DERIVED

  • 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.

    PMID: 34611902DERIVED

MeSH Terms

Conditions

Smoking CessationVaping

Interventions

Tobacco Use Cessation DevicesNicotine Replacement TherapyNicotine

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmoking

Intervention Hierarchy (Ancestors)

TherapeuticsDrug TherapySolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Natalie Walker, PhD

    National Institute for Health Innovation, School of Population Health, University of Auckland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Population Health (Honorary)

Study Record Dates

First Submitted

August 9, 2015

First Posted

August 13, 2015

Study Start

March 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

NZ(1)