Evaluation of Dependence and Nicotine Replacement Therapy-Supported Cessation Efforts Among Regular Electronic Cigarette Use

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

The study has two parts.

It had two arms (groups): Brief Behavioral Counseling (active comparator) and Brief Behavioral Counseling + NRT (experimental).

The registry classes the interventions as behavioral and drug.

More on the Plan

Most NRT products are available over the counter, making them easily accessible to not only cigarette smokers but also electronic cigarette (ECIG) users.

A major limitation of these studies is the reliance on self-reports of ECIG abstinence.

Unlike combustible tobacco products, ECIGs produce minimal carbon monoxide (CO).

Consequently, exhaled CO tests used to confirm acute abstinence from products like cigarettes cannot be used for ECIG abstinence.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Participants will be at least 21 years of age. Report smoking either \<100 lifetime cigarettes, or \>100 lifetime cigarettes but no regular smoking (some days or everyday) in the past year. Current ECIG use will be confirmed via a semi-quantitative urinary cotinine value \> 4 (NicAlert), and current non-smoking status will be confirmed via an expired air CO level \<7ppm.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: preference for ecig liquid containing a substance other than nicotine (e.g., thc, cannabidiol); use of thc/cannabis \>15 days in past month, or being unwilling or unable to abstain from thc/cannabis during study conditions; use of non-cigarette tobacco (e.g., cigars, smokeless, hookah) on more than 5 days in the past month.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

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

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2026-09-01 with completion listed for 2028-06-30.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Subjective Measures (time frame: From baseline (i.e., Day 1) through study completion, an average of 10 days). Urine PG and cotinine (time frame: From baseline (i.e., Day 1) through study completion, an average of 10 days). Exhaled CO (time frame: From baseline (i.e., Day 1) through study completion, an average of 10 days).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 100 people.

Its status is not yet recruiting; 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.