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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine patch
* Device: e-cigarette
* Drug: Nicotine
* Behavioral: Behavioural support


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patch<br>21mg nicotine patch daily for 14 weeks (including a 2 week prequit period) plus behavioural support for six weeks post-quit | Drug: Nicotine patch<br>* A transdermal patch that slowly releases nicotine into the body through the skin.<br>* Other names: Nicotine replacement therapy;Behavioral: Behavioural support<br>* Withdrawal-oriented behavioural support<br>* Other names: Smoking cessation behavioural support;|
| Active Comparator: Patch and nicotine-free e-cigarette<br>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 patch<br>* A transdermal patch that slowly releases nicotine into the body through the skin.<br>* Other names: Nicotine replacement therapy;Device: e-cigarette<br>* A electronically powered device that delivers to the user an aerosol of propylene glycol and/or glycerine, with or without flavourings and nicotine.<br>* Other names: electronic nicotine delivery device;Behavioral: Behavioural support<br>* Withdrawal-oriented behavioural support<br>* Other names: Smoking cessation behavioural support;|
| Active Comparator: Patch and nicotine e-cigarette<br>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 patch<br>* A transdermal patch that slowly releases nicotine into the body through the skin.<br>* Other names: Nicotine replacement therapy;Device: e-cigarette<br>* A electronically powered device that delivers to the user an aerosol of propylene glycol and/or glycerine, with or without flavourings and nicotine.<br>* Other names: electronic nicotine delivery device;Drug: Nicotine<br>* Nicotine contained in e-liquid (e-juice) used in e-cigarettes<br>* Other names: Nicotine liquid;Behavioral: Behavioural support<br>* Withdrawal-oriented behavioural support<br>* Other names: Smoking cessation behavioural support;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic Cigarettes, Nicotine Patch, Smoking Cessation