Trial intelligence / Profile preview

Nicotine Patch vs Gum in Adolescent Tobacco Dependence

NCT01208935Phase 3

Key facts

Status: Completed
Start: Aug 1999
Primary completion: Jun 2004
Countries: 1
Sponsor: National Institute on Drug Abuse
Modality: Transdermal Patches, Small Molecules

Drugs: nicotine patch
Conditions: tobacco dependence

Overview

Phase 3, randomised, double-blind trial of nicotine patch in tobacco dependence (3 arms), sponsored by National Institute on Drug Abuse. Primary endpoints: Safety (Adverse Side-Effects), Tolerability and Compliance and 3 more. Started Aug 1999; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Nicotine Patch
Nicotine Transdermal System (21 mg) + Placebo Gum
Nicotine Gum
Nicotine Gum (2 mg and 4 mg) + Placebo Patch
Placebo
Placebo Patch + Placebo Gum

Who it enrols

Adolescents (13-17 years) with a history of smoking 11 or more cigarettes per day for at least one year and a Fagerström Test for Nicotine Dependence score of 5 or above. Exclusion criteria include history of cardiac disease, active dependence on other drugs, severe psychiatric disorders, and previous use of NRT.

Endpoints

Primary

Safety (Adverse Side-Effects)
Tolerability and Compliance
Efficacy (Smoking Abstinence/Reduction)
Weight and Body Mass Index
Cognitive Performance Tests

Secondary

Correlation of Pre-treatment Nicotine Exposure with Withdrawal Intensity
Correlation of Biological Markers with Self-Reports
Smoking Topography Data

Beyond the preview

Go deeper on NCT01208935.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01208935.