ASCEND: A Study of Cessation using Electronic Nicotine Devices

Conditions

None listed

Brief 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

Brigid O’Brien, Oliver Knight-West, Natalie Walker, Varsha Parag, Chris Bullen

Tobacco Induced Diseases2015-03-2384 citations

10.1186/s12971-015-0030-2

Electronic cigarettes for smoking cessation: a randomised controlled trial.

Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, Walker N.

2013-09-09791 citations

10.1016/s0140-6736(13)61842-5

Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation.

Bullen C, Williman J, Howe C, Laugesen M, McRobbie H, Parag V, Walker N.

2013-03-0841 citations

10.1186/1471-2458-13-210

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/d

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Participants will be smokers from throughout Auckland who want to stop smoking. 2. Are at least 18 years of age, 3. Have smoked on average at least 10 cigarettes a day for the past year 4. Are able to provide verbal consent 5. Have access to a phone

Exclusion criteria

1. Pregnant women and women who are breastfeeding will be excluded from the trial, 2. Current users of another smoking cessation medication ((e.g. other forms of NRT, buproprion [Zyban], clonidine, nortriptyline [Norpress] or vareniciline [Champix]) 3. Those enrolled in another smoking cessation programme (e.g. Txt2Quit) or trial. 4. Had a heart attack, stroke or severe angina in the previous two weeks 5. Poorly controlled asthma or other airways disease (from history 6. Poorly controlled diabetes mellitus 7. Severe allergies 8. Poorly controlled psychiatric disorders 9. Current chemical dependence other than that involving nicotine.

Outcome results