Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

Plain-language guide to NCT02511236: phase 4 randomized trial of Therapeutic nicotine (patch, non-peptide), 356 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02511236
Phase: phase 4
Status: completed
Start: 2015-08
Completion (planned or actual): 2019-10-23
Participants: 356 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Smoking Cessation
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

It had two arms (groups): Group Cognitive Behavioral Therapy (experimental) and General Health Education (active comparator).

The registry classes the interventions as behavioral and drug.

Who Took Part

356 actual participants 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.

Examples of who could join: Self-identify as African American/Black, Hispanic (any race), or White non-Hispanic. Smoke at least 5 cigarettes/day or carbon monoxide (CO) reading of at least 8 ppm. Be over age 18. Speak/read English and/or Spanish.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: contraindications for transdermal nicotine patch therapy (tnp); cognitive or mental health impairment that inhibits group treatment; currently being treated for smoking cessation, alcoholism, or illicit drug use.

How the Study Was Run

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

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-08 with completion listed for 2019-10-23.

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

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The Number of Participants Reporting 7 Day Point Prevalence Abstinence (time frame: 12-months). Change in Perceived Stress Scores (time frame: Baseline, 4 weeks). Change in Depressive Symptoms Scores (time frame: Baseline, 4 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 356 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.