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

What Was Tested

This registered phase 3 trial tested Therapeutic nicotine (patch, non-peptide).

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.

It had three arms (groups): Patch (active comparator), Patch and nicotine-free e-cigarette (active comparator) and Patch and nicotine e-cigarette (active comparator).

The registry classes the interventions as behavioral, device and drug.

More on the Plan

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.

Who Took Part

1124 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Smoke and want to quit in the next three months. 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.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: pregnant women; women who are breastfeeding; current users of nrt products.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2016-03 with completion listed for 2018-08.

It ran at 1 site in New Zealand.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Continuous abstinence (Russell Standard) (time frame: Six months post quit date).

It also tracked 17 secondary outcomes, for example Continuous abstinence, 7-day point prevalence abstinence, Number of cigarettes smoked, Time to relapse, Withdrawal and Use of any other smoking cessation methods/products.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1124 people.

With 1124 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.