UW Withdraw From Tobacco Study

Plain-language guide to NCT04969198: phase 2 interventional trial of Therapeutic nicotine (patch, non-peptide), 232 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04969198
Phase: phase 2
Status: completed
Start: 2021-07-13
Completion (planned or actual): 2022-09-21
Participants: 232 (actual)
Design: na, open label (everyone knows who gets what), health_services_research
Conditions studied: Tobacco Dependence
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success.

However, in order to ensure that a measure of tobacco withdrawal is sensitive to severe withdrawal, it is essential to examine a period of unmedicated abstinence.

It had 1 arm (groups): Nicotine Patch + Nicotine Mini Lozenge (experimental).

The registry classes the interventions as drug.

Who Took Part

232 actual participants took part.

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

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

Examples of who could join: Smoke ≥5 cigarettes per day for past year. ≥21 years old. Able to read and write English. Desire to quit smoking. Not currently engaged in cessation treatment.

The full record lists 11 inclusion and 13 exclusion criteria; among the exclusions: used pipe tobacco, cigars, snuff, or chew more than twice in the past week; used e-cigarette, vaping, or any other electronic nicotine delivery product more than twice in the past week; currently taking varenicline or bupropion.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-07-13 with completion listed for 2022-09-21.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

It also tracked 9 secondary outcomes, for example Change in WSWS2-L Subscale Score : Craving, Change in WSWS2-L Subscale Score : Negative Affect, Change in WSWS2-L Subscale Score : Concentration, Change in WSWS2-L Subscale Score : Sleep Problems, Change in WSWS2-L Subscale Score: Hunger and Change in WSWS2-L Subscale Score : Restlessness.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Therapeutic nicotine (patch, non-peptide) in 232 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.

Our Notes on the Compound

Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.

Therapeutic nicotine (patch, non-peptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.