Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The registry classes the interventions as drug.

More on the Plan

Consequently, use of both the patch and gum should be tolerable in this population with only minor adverse side-effects.

Who Took Part

157 actual participants took part.

It was open to people of any sex aged from 13 years up to 17 years.

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

Examples of who could join: History of smoking 11 or more cigarettes per day (cpd) for at least one year. Fagerström Test for Nicotine Dependence score of 5 and above. General good health as verified by history, physical, psychiatric examination and screening laboratory tests.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: history of cardiac disease; active dependence on any drug other than nicotine (as assessed by the dusi); current or past severe psychiatric disorders as per the diagnostic interview for children and adolescents (dica-a).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant and care provider.

It started in 1999-08 with completion listed for 2004-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: a)Safety will be tabulated as a function of reported and observed adverse side-effects. b)Tolerability and Compliance by attendance at visits, completeness of smoking cessation diaries, saliva cotinine, and correlations of biologic markers (expired air CO and saliva thiocyanate) with smoking cessation diaries. d) Weight and body mass index (BMI).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 157 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.