The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products

What Was Tested

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

This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cigarettes.

It had four arms (groups): Nicotine e-cigs + Nicotine patches (active comparator), Non-nicotine e-cigs + Nicotine patches (active comparator), Nicotine e-cigs + Placebo patches (active comparator) and Non-nicotine e-cigs + Placebo patches (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Behavioral or "habit" aspects of e-cigarette use will be controlled for by the groups receiving non-nicotine e-cigarettes.

Initially the study design included placebo patch control conditions, but due to limitations in budget and period of support, enrollment in these these arms was discontinued.

All participants currently receive active nicotine patches.

Who Took Part

94 actual participants 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: Smoke an average of at least 10 cigarettes per day;. Have smoked at least one cumulative year;. Have an expired air CO reading of at least 10ppm;. Have a body weight of \> 110 lbs. (50 kg) and ≤ 300 lbs. (136 kg);. Are able to read and understand English;.

The full record lists 11 inclusion and 40 exclusion criteria; among the exclusions: seeking treatment for nicotine dependence; hypotension (with symptoms) - systolic bp \< 90 mm hg, diastolic bp \< 60 mm hg; coronary heart disease with symptoms (e.g., chest pain).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and care provider.

It started in 2018-08-06 with completion listed for 2021-05-31.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Expired Air Carbon Monoxide (CO) to Assess Recent Smoking (time frame: Week 8).

It also tracked 3 secondary outcomes, for example Cigarette Use, Assessed by Self-report in Daily Dairies, E-cigarette Use, Assessed by Self-report in Daily Dairies and Total Urinary 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 94 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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