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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Patch

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

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

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

Behavioural support

Intervention Type BEHAVIORAL

Withdrawal-oriented behavioural support

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

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

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

e-cigarette

Intervention Type DEVICE

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

Behavioural support

Intervention Type BEHAVIORAL

Withdrawal-oriented behavioural support

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

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

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

e-cigarette

Intervention Type DEVICE

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

Nicotine

Intervention Type DRUG

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

Behavioural support

Intervention Type BEHAVIORAL

Withdrawal-oriented behavioural support

Interventions

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Nicotine patch

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

Intervention Type DRUG

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.

Intervention Type DEVICE

Nicotine

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

Intervention Type DRUG

Behavioural support

Withdrawal-oriented behavioural support

Intervention Type BEHAVIORAL

Other Intervention Names

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Nicotine replacement therapy electronic cigarette electronic nicotine delivery device Nicotine liquid Smoking cessation behavioural support

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes