Evaluation of the Electronic Cigarette Withdrawal Syndrome

What Was Tested

In this early phase 1 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The goal of this project is to rigorously evaluate the nature of e-cigarette withdrawal in exclusive e-cigarette users during a monitored abstinence period and the role of nicotine in the expression of this withdrawal syndrome.

It had three arms (groups): Transdermal Nicotine Patch (experimental), Transdermal Placebo Patch (placebo comparator) and No Patch (no intervention).

Participants assigned to this condition will receive a blinded nicotine patch and will wear the patch on their upper arm, per the manufacturer's instructions.

Participants assigned to this condition will not receive a patch.

The registry classes the interventions as drug.

More on the Plan

This project will use a rigorous residential laboratory design to evaluate e-cigarette withdrawal expression and experimentally determine the role of nicotine in this syndrome.

Healthy adults who exclusively use e-cigarettes will undergo monitored e-cigarette abstinence over seven days (1 week) in a residential unit.

The investigators will evaluate the contribution of nicotine to withdrawal expression by assigning participants to one of three conditions: active nicotine patch, placebo patch control, or no patch to control for expectancies.

Who Took Part

Enrollment: 150 planned participants were the target.

It was open to people of any sex aged from 21 years up to 55 years.

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

Examples of who could join: 21-55 years old. Good general health as reviewed by study medical team. Vital signs in normal range as reviewed by study medical team. Negative urine test for illicit drug use (excluding THC) and negative breath alcohol test. Daily use of a nicotine-containing e-cigarette for at least 6 months.

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month; current use of over-the-counter (otc) or prescription medications that may impact safety; use cannabis \>2 times per week.

How the Study Was Run

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

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

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

It started in 2023-11-28 with completion listed for 2028-06-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in Hughes-Hatsukami Withdrawal Scale (time frame: Baseline, every 4 hours up to 16 hours). Change in Smoking urges as assessed by the Tiffany-Drobes Questionnaire of Smoking Urges (QSU) Brief (time frame: Baseline, every 4 hours up to 16 hours). Change in Positive and Negative Affect Schedule (PANAS) (time frame: Baseline, every 4 hours up to 16 hours).

It also tracked 3 secondary outcomes, for example Change in E-Cigarette Demand Intensity, Change in E-Cigarette Demand Elasticity and Return to Use.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 150 people.

It is still 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.