Research and Innovation to Stop E-cigarette/Vaping in Young Adults

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The aim of this study is to test intervention components to help young adults quit vaping.

A 2x2 factorial design will be used where all participants receive quitline-delivered behavioral phone counseling, and components to be tested are a digital intervention (with text and online cessation support) and nicotine replacement therapy (NRT).

The research questions and hypotheses for this study are: 1.

It had four arms (groups): CoachingOnlyArm (experimental), DigitalArm (experimental), CoachingNRTArm (experimental) and DigitalNRTArm (experimental).

Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.

Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.

Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.

The registry classes the interventions as behavioral and drug.

More on the Plan

The investigators will recruit a national, nonprobability sample of young adults (18-24 year olds) who vape nicotine.

All study components will be delivered by phone, mail, online, and mobile device.

All participants will receive up to 2 coaching calls and will be randomized to one of four groups: no NRT, no Digital; Digital, no NRT; NRT, no Digital; or NRT and Digital.

Participants (final sample size n = 504) must complete one coaching call to be enrolled in the study.

Who Took Part

Enrollment: 508 actual participants took part.

It was open to people of any sex aged from 18 years up to 24 years.

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

Examples of who could join: Current, regular user of nicotine e-cigarettes (20+ days in the last month). Exclusive e-cigarette user (no other tobacco in the last 30 days; or no other tobacco in the last 90 days if smoked 100+ cigarettes or cigarillos in lifetime). Interest in quitting in the next 30 days. Ownership of a smartphone device. Ability to speak and read English.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: pregnant or breastfeeding; other household members in study.

How the Study Was Run

It was run as a randomized, factorial and single-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.

In this single-blind Therapeutic nicotine (patch, non-peptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2021-07-28 with completion listed for 2022-12-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 7-day Point Prevalence Vaping Abstinence (time frame: 3 months after the first coaching call (occurred at baseline)).

It also tracked 4 secondary outcomes, for example Vaping Abstinence, E-cigarette Dependence - PROMIS-E and Changes in E-cigarette Use Frequency.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 508 people.

With 508 participants it is a large trial for this field.

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.