ASCEND-II: The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking Cessation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Patch 21mg nicotine patch daily for 14 weeks (including a 2 week prequit period) plus behavioural support for six weeks post-quit |
Drug: Nicotine patch
A transdermal patch that slowly releases nicotine into the body through the skin.
Other Names:
Behavioral: Behavioural support
Withdrawal-oriented behavioural support
Other Names:
|
| Active Comparator: 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 |
Drug: Nicotine patch
A transdermal patch that slowly releases nicotine into the body through the skin.
Other Names:
Device: 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.
Other Names:
Behavioral: Behavioural support
Withdrawal-oriented behavioural support
Other Names:
|
| Active Comparator: 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 |
Drug: Nicotine patch
A transdermal patch that slowly releases nicotine into the body through the skin.
Other Names:
Device: 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.
Other Names:
Drug: Nicotine
Nicotine contained in e-liquid (e-juice) used in e-cigarettes
Other Names:
Behavioral: Behavioural support
Withdrawal-oriented behavioural support
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Continuous abstinence (Russell Standard) [Six months post quit date]
Self-report of smoking not more than five cigarettes from the Quit date, supported by biochemical validation (expired air carbon monoxide).
Secondary Outcome Measures
- Continuous abstinence [One, three and 12 months post quit date]
Self-report of smoking not more than five cigarettes from the Quit date
- 7-day point prevalence abstinence [Participant's set quit date, then one, three, six and 12 months post quit date]
Self-report of having smoked no cigarettes (not even a puff) in the past seven days, with biochemical verification at six months only
- Number of cigarettes smoked [Participant's set quit date, then one, three, six and 12 months post quit date]
Self-report of number of cigarettes smoked per day (or when smoking for non-daily smokers)
- Smoking reduction [Participant's set quit date, then one, three, six and 12 months post quit date]
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.
- Time to relapse [One, three, and six months post quit date]
Time to relapse back to daily smoking from quit date
- Withdrawal [Participant's set quit date, then at one month post quit date]
The physical signs and symptoms associated with withdrawal, measured using the Mood and Physical Symptoms Scale (MPSS).
- Self-efficacy [Participant's set quit date]
Self-rated chances of quitting, measured on a scale of 1-5 where 1=very low and 5=very high
- Use of any other smoking cessation methods/products [Participant's set quit date, then one, three, six and 12 months post quit date]
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.
- Serious adverse events [Participant's set quit date, then one, three, six and 12 months post quit date]
- Cost [Participant's set quit date, then one, three, six and 12 months post quit date]
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.
- Medication compliance [Participant's set quit date, then one and three months post quit date]
How frequently they used their allocated product
- Crossover [Participant's set quit date, then one, three, six and 12 months post quit date]
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.
- Additional e-cigarette support [Participant's set quit date, then one, three, six and 12 months post quit date]
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.
- Dual use [Participant's set quit date, then one, three, six and 12 months post quit date]
Defined as use of both allocated treatment and continued smoking of cigarettes
- Continuation of treatment use [Six and 12 months post quit date]
Defined as continued use of allocated treatment after the end of the designated treatment period (12 weeks post-quit).
- Perception of their allocated product(s) [Participant's set quit date, then one and three months post quit date]
Participants will be asked what they liked and disliked about their allocated products (free text)
- Recommendations [Participant's set quit date, then one and three months post quit date]
Participant's will be asked whether they would recommend their allocated treatment to another smoker who wanted to quit (Yes/No)
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institute for Health Innovation, University of Auckland | Auckland | North Island | New Zealand | 1072 |
Sponsors and Collaborators
- University of Auckland, New Zealand
- Health New Zealand Ltd, Christchurch, New Zealand
- Auckland District Health Board
Investigators
- Principal Investigator: Natalie Walker, PhD, National Institute for Health Innovation, School of Population Health, University of Auckland
Study Documents (Full-Text)
None provided.More Information
Publications
- U1111-1172-9632