End Nicotine Dependence Clinic

What Was Tested

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

The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio.

The study will also look at how different people respond to the program.

It had four arms (groups): Group Counseling (experimental), Individual Counseling (experimental), Telephone Counseling (experimental) and Video Counseling (experimental).

The registry classes the interventions as behavioral and drug.

More on the Plan

Objective 1: To examine the feasibility of conducting an evidence-based, cognitive behavioral therapy (CBT) for tobacco cessation delivered in multiple formats.

Participants will have the opportunity to receive a CBT-based tobacco intervention delivered several possible formats (face-to-face, telephone, video-counseling) based on availability and participant preferences.

As supplemental treatment, participants may have the option to receive up to 8 weeks of nicotine replacement therapy and text-messaging support.

Objective 2: To examine the rates of smoking abstinence across intervention formats.

Who Took Part

56 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: Current smokers who would like help quitting (≥ 5 cigarettes per day and/or have a breath carbon monoxide (CO) reading of ≥ 8 ppm). Able to speak and read English. Able to engage using at least one of the intervention formats.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: enrollment in another cessation program; do not speak and read english; do not have access to at least one intervention format.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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

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

It started in 2018-01-09 with completion listed for 2019-12-06.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Rate of 24 hour smoking abstinence across intervention (time frame: Up to 24 hours after session 1).

It also tracked 6 secondary outcomes, for example Rate of 7-day smoking abstinence across intervention, Rate of 28-day smoking abstinence across intervention, Average intervention rating, Sessions completed, Study Retention and Nicotine Replacement Therapy (NRT) Completed.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Therapeutic nicotine (patch, non-peptide) in 56 people.

The trial is marked completed; 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.