Inpatient Smoking Cessation Pilot Program

Plain-language guide to NCT05060965: early phase 1 interventional trial of Therapeutic nicotine (patch, non-peptide). Who took part, design and what was measured.

Key Facts

Registry ID: NCT05060965
Phase: early phase 1
Status: withdrawn
Start: 2019-10-01
Completion (planned or actual): 2023-04
Participants: n/a (actual)
Design: na, open label (everyone knows who gets what), health_services_research
Conditions studied: Tobacco Use Cessation
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (early phase 1) is built around Therapeutic nicotine (patch, non-peptide).

The investigators are focusing on addressing caregiver smoking as a modifiable risk factor during time of child's hospitalization as a window of opportunity to provide counseling and education to families on secondhand and third hand smoke exposure as well as information on NRT products to heighten caregiver contemplation for quitting.

It had 1 arm (groups): Cessation intervention (experimental).

The registry classes the interventions as drug and other.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: pregnant or breast feeding maternal caregivers.

How the Study Was Run

Design: 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 2019-10-01 with completion listed for 2023-04.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

The main thing measured (primary outcome): Change in Self-reported attempts to quit smoking (time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months).

It also tracked 2 secondary outcomes, for example Change in Frequency of usage of outpatient tobacco cessation services and Change in Usage of nicotine replacement therapy products.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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.

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.