Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families

What Was Tested

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

It had two arms (groups): Motivational advice and free NRT (experimental) and Quitline referral (active comparator).

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 32 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Report that a household resident smokes at least 5 cigarettes per day, on average, within the 2 months preceding the screening visit. Agree to attend intervention sessions. And have access to a telephone.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: were unable to read, write, and speak english; were unable or unwilling to provide signed consent for participation; and were unable or unwilling to meet study requirements for data collection and intervention purposes.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

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 2017-10-29 with completion listed for 2018-06-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff (time frame: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)).

It also tracked 11 secondary outcomes, for example Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant, Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner, Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts, Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts, Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts and Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 32 people.

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

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.