ASCEND: A Study of Cessation using Electronic Nicotine Devices
A three arm single blind parallel group randomised controlled clinical trial to evaluate the efficacy, acceptability, utilisation and safety of an electronic cigarette (ENDS) as a smoking cessation aid (ASCEND)
Health Research Council NZ
653 participants
Sep 6, 2011
Interventional
Conditions
Summary
Most smokers know smoking is harmful to their health but find it hard to stop, largely because of addiction to nicotine and the habit of using cigarettes for many years. Medical nicotine (such as nicotine patch, the most widely used quit smoking product) doubles the chances of successfully quitting but doesn’t deal with smoking habits. This study tests a new nicotine delivery system, the e-cigarette or ENDS, to see if it is better than nicotine patch at helping smokers quit. Participants will be randomly allocated to one of three groups: e-cigarettes with 16mg nicotine cartridges, nicotine patches, or e-cigarettes with 0 mg nicotine cartridges, used for 13 weeks. We will phone them at one, three and six months after quit day to compare quitting, acceptability, use and side effects. Even if only modestly effective at helping smokers quit, e-cigarettes have potential for a positive health impact because of their popularity among smokers
Eligibility
Inclusion Criteria6
- Participants will be smokers from throughout Auckland
- who want to stop smoking.
- Are at least 18 years of age,
- Have smoked on average at least 10 cigarettes a day for the past year
- Are able to provide verbal consent
- Have access to a phone
Exclusion Criteria9
- Pregnant women and women who are breastfeeding will be excluded from the trial,
- Current users of another smoking cessation medication ((e.g. other forms of NRT, buproprion [Zyban], clonidine, nortriptyline [Norpress] or vareniciline [Champix])
- Those enrolled in another smoking cessation programme (e.g. Txt2Quit) or trial.
- Had a heart attack, stroke or severe angina in the previous two weeks
- Poorly controlled asthma or other airways disease (from history
- Poorly controlled diabetes mellitus
- Severe allergies
- Poorly controlled psychiatric disorders
- Current chemical dependence other than that involving nicotine.
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Interventions
Arm 1. 16mg Nicotine Cartridges (max 2 cartridges/day) used in "e-cigarettes" (Electronic Nicotine Device (ENDS)) for 13 weeks plus 8 weeks of smoking behavioural support supplied by Quitline New Zealand (NZ) both from baseline. Arm 2. 0mg Nicotine Cartridges (max 2 cartridges/day) used in "e-cigarettes" (Electronic Nicotine Device (ENDS)) for 13 weeks plus 8 weeks of smoking behavioural support supplied by Quitline New Zealand (NZ) both from baseline. Arm 3. 21 mg Nicotine Patch (max 1 patch/day used for 13 weeks plus 8 weeks of smoking behavioural support supplied by Quitline New Zealand (NZ) both from baseline.
Locations(1)
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ACTRN12610000866000