Project HEALS (Helping and Empowering pAtients for Living a Life Smoke-free

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Group 1: Usual Care (active comparator) and one (experimental).

Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges).

Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges), 6 telephone counseling sessions over 6 months, and access to a web based video.

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 21 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18 years of age or older. Smoked at least 100 cigarettes in lifetime. Current smoking (defined as self-report of any smoking, even a puff, in the past 30 days). Able to read and write English. Not currently enrolled in a smoking cessation program.

The full record lists 8 inclusion and 4 exclusion criteria; among the exclusions: current use of tobacco cessation medications; another household member enrolled in this study; contraindication of nicotine patch, unless under the supervision of a physician as advised by project staff.

How the Study Was Run

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

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.

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 2021-06-07 with completion listed for 2023-01-28.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants who meet inclusion criteria (time frame: Baseline). Percentage of participants who agree to participate in the study (time frame: Baseline). Percentage of participants completing baseline assessment (time frame: Baseline).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 21 people.

Its size is small, so on its own it can only give an early look.

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.