NCT02521662

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

A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,124 (actual)
• Sponsor: University of Auckland, New Zealand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicotine patch	A transdermal patch that slowly releases nicotine into the body through the skin.
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.
DRUG	Nicotine	Nicotine contained in e-liquid (e-juice) used in e-cigarettes
BEHAVIORAL	Behavioural support	Withdrawal-oriented behavioural support

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2015-08-13
• Last updated: 2021-08-19

Locations

1 site across 1 country: New Zealand