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| Name | Class |
|---|---|
| Health New Zealand Ltd, Christchurch, New Zealand | UNKNOWN |
| Auckland District Health Board | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patch | Active Comparator | 21mg nicotine patch daily for 14 weeks (including a 2 week prequit period) plus behavioural support for six weeks post-quit |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | A transdermal patch that slowly releases nicotine into the body through the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous abstinence | Self-report of smoking not more than five cigarettes from the Quit date | One, three and 12 months post quit date |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Walker, PhD | National Institute for Health Innovation, School of Population Health, University of Auckland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Health Innovation, University of Auckland | Auckland | North Island | 1072 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30808668 | Background | 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. | |
| 31515173 |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D000095488 | Nicotine Replacement Therapy |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
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|
| e-cigarette | 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 | Drug | Nicotine contained in e-liquid (e-juice) used in e-cigarettes |
|
|
| Behavioural support | Behavioral | Withdrawal-oriented behavioural support |
|
|
| Participant's set quit date, then one, three, six and 12 months post quit date |
| Number of cigarettes smoked | Self-report of number of cigarettes smoked per day (or when smoking for non-daily smokers) | Participant's set quit date, then one, three, six and 12 months post quit date |
| 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. | Participant's set quit date, then one, three, six and 12 months post quit date |
| Time to relapse | Time to relapse back to daily smoking from quit date | One, three, and six months post quit date |
| Withdrawal | The physical signs and symptoms associated with withdrawal, measured using the Mood and Physical Symptoms Scale (MPSS). | Participant's set quit date, then at one month post quit date |
| Self-efficacy | Self-rated chances of quitting, measured on a scale of 1-5 where 1=very low and 5=very high | Participant's set quit date |
| 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. | Participant's set quit date, then one, three, six and 12 months post quit date |
| Serious adverse events | Participant's set quit date, then one, three, six and 12 months post quit date |
| 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. | Participant's set quit date, then one, three, six and 12 months post quit date |
| Medication compliance | How frequently they used their allocated product | Participant's set quit date, then one and three months post quit date |
| 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. | Participant's set quit date, then one, three, six and 12 months post quit date |
| 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. | Participant's set quit date, then one, three, six and 12 months post quit date |
| Dual use | Defined as use of both allocated treatment and continued smoking of cigarettes | Participant's set quit date, then one, three, six and 12 months post quit date |
| Continuation of treatment use | Defined as continued use of allocated treatment after the end of the designated treatment period (12 weeks post-quit). | Six and 12 months post quit date |
| Perception of their allocated product(s) | Participants will be asked what they liked and disliked about their allocated products (free text) | Participant's set quit date, then one and three months post quit date |
| Recommendations | Participant's will be asked whether they would recommend their allocated treatment to another smoker who wanted to quit (Yes/No) | Participant's set quit date, then one and three months post quit date |
| 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. |
| 39868569 | Derived | 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. |
| 34611902 | Derived | 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. |
| D006571 |
| Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |