Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment

What Was Tested

The trial (phase 2) is built around Therapeutic nicotine (patch, non-peptide).

The purpose of this research study is to determine whether combining electronic nicotine delivery systems (ENDS) with nicotine patch treatment will augment abstinence rates compared to either treatment alone.

It had three arms (groups): Nicotine ENDS + Nicotine Patch (experimental), Nicotine ENDS + Placebo Patch (active comparator) and Placebo ENDS + Nicotine Patch (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

Cigarette smokers, who are motivated to quit smoking but who rate the inhalation aspects of smoking as important will be randomized to three groups: Group 1.

Nicotine ENDS + nicotine patch; Group 2: Nicotine ENDS + placebo patch; Group 3: Placebo ENDS + Nicotine patch.

Starting with week 2, participants will receive nicotine-containing (or placebo) ENDS devices (menthol or non-menthol versions in accordance with their baseline preference).

They will also be instructed to substitute ENDS for as many cigarettes as possible in this week.

Who Took Part

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have no known serious medical conditions;. Smoke an average of at least 10 cigarettes per day;. Have an expired air CO reading of at least 15 ppm;. Able to read and understand English;. Express a desire to quit smoking in the next thirty days;.

The full record lists 6 inclusion and 40 exclusion criteria; among the exclusions: coronary heart disease;; lifetime history of heart attack;; cardiac rhythm disorder (irregular heart rhythm);.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

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 and care provider.

It started in 2018-07 with completion listed for 2020-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Continuous four-week abstinence from smoking during treatment (time frame: Weeks 4-8 post target Quit Day).

It also tracked 3 secondary outcomes, for example Continuous four-week abstinence from smoking after withdrawal of ENDS, Continuous four-week abstinence from smoking after withdrawal of nicotine patches and Seven-day point abstinence from smoking at 6 months post Quit Day.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in people.

It was withdrawn before enrolling anyone; 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.