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

University of Auckland, New Zealand

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Behavioral: Behavioural support; Drug: Nicotine; Device: e-cigarette; Drug: Nicotine patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02521662

U1111-1172-9632

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,124 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,124 participants in 3 patient groups

Patch

Active Comparator group

Description:

21mg nicotine patch daily for 14 weeks (including a 2 week prequit period) plus behavioural support for six weeks post-quit

Treatment:

Drug: Nicotine patch

Behavioral: Behavioural support

Patch and nicotine-free e-cigarette

Active Comparator group

Description:

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

Treatment:

Device: e-cigarette

Drug: Nicotine patch

Behavioral: Behavioural support

Patch and nicotine e-cigarette

Active Comparator group

Description:

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

Treatment:

Device: e-cigarette

Drug: Nicotine patch

Drug: Nicotine

Behavioral: Behavioural support