Clinical trial NCT02521662: The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking Cessation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: Electronic Cigarettes
Nicotine Patch
Smoking Cessation
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: Health New Zealand Ltd, Christchurch, New Zealand
name: Auckland District Health Board
First posted: 2015-08-13
Enrollment: 1124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Continuous abstinence (Russell Standard)
timeFrame: Six months post quit date
Secondary outcomes:
measure: Continuous abstinence
timeFrame: One, three and 12 months post quit date
measure: 7-day point prevalence abstinence
timeFrame: Participant's set quit date, then one, three, six and 12 months post quit date
measure: Number of cigarettes smoked
timeFrame: Participant's set quit date, then one, three, six and 12 months post quit date
measure: Smoking reduction
timeFrame: Participant's set quit date, then one, three, six and 12 months post quit date
measure: Time to relapse
timeFrame: One, three, and six months post quit date
measure: Withdrawal
timeFrame: Participant's set quit date, then at one month post quit date
measure: Self-efficacy
timeFrame: Participant's set quit date
measure: Use of any other smoking cessation methods/products
timeFrame: Participant's set quit date, then one, three, six and 12 months post quit date
measure: Serious adverse events
timeFrame: Participant's set quit date, then one, three, six and 12 months post quit date
measure: Cost
timeFrame: Participant's set quit date, then one, three, six and 12 months post quit date
measure: Medication compliance
timeFrame: Participant's set quit date, then one and three months post quit date
measure: Crossover
timeFrame: Participant's set quit date, then one, three, six and 12 months post quit date
measure: Additional e-cigarette support
timeFrame: Participant's set quit date, then one, three, six and 12 months post quit date
measure: Dual use
timeFrame: Participant's set quit date, then one, three, six and 12 months post quit date
measure: Continuation of treatment use
timeFrame: Six and 12 months post quit date
measure: Perception of their allocated product(s)
timeFrame: Participant's set quit date, then one and three months post quit date
measure: Recommendations
timeFrame: Participant's set quit date, then one and three months post quit date
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: National Institute for Health Innovation, University of Auckland
state: North Island
Study officials:
affiliation: National Institute for Health Innovation, School of Population Health, University of Auckland
name: Natalie Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.