Individualizing Pharmacotherapy for African American Smokers

What Was Tested

The trial (phase 3) is built around Therapeutic nicotine (patch, non-peptide).

In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working.

This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.

It had two arms (groups): Usual Care (UC) (active comparator) and Optimized Care (OPT) (experimental).

196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.

The registry classes the interventions as drug.

More on the Plan

The primary outcome is biochemically-verified smoking status at Week 12.

Who Took Part

Enrollment: 392 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: Non-Hispanic African American. ≥ 18 years of age. Smoke 5-30 cigarettes per day (CPD). Daily cigarette smoker. Smoked at current rate for \> 6 months.

The full record lists 9 inclusion and 7 exclusion criteria; among the exclusions: use of non-cigarette tobacco products in past 30 days; pregnant, contemplating getting pregnant, or breastfeeding; unstable housing (e.g., street, shelter).

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.

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

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 2019-05-01 with completion listed for 2021-11-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Biochemically Verified Smoking Abstinence at Week 12 (time frame: Week 12).

It also tracked 2 secondary outcomes, for example Number of Participants With Biochemically Verified Smoking Abstinence at Week 18 and Number of Participants With Biochemically Verified Smoking Abstinence at Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 392 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.