CompletedPhase 3Phase 4ACTRN12610000866000

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)


Sponsor

Health Research Council NZ

Enrollment

653 participants

Start Date

Sep 6, 2011

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether electronic nicotine devices (e-cigarettes) can help smokers quit. It is for adults aged 18 and older in Auckland who smoke at least 10 cigarettes a day and want to stop smoking.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Zeal

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)

New Zealand

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