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

Phase 2

Completed

• Conditions: Tobacco Dependence

• Registration Number: NCT01208935
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

The purpose of this study is to test the safety, tolerability, compliance and efficacy of two different forms of nicotine replacement therapy (NRT) (the nicotine transdermal patch and the nicotine gum) in a nicotine-dependent adolescent population.

Detailed Description

We hypothesize that two nicotine replacement delivery systems (patch and gum) are both safe and efficacious for the treatment of adolescent nicotine dependence. Consequently, use of both the patch and gum should be tolerable in this population with only minor adverse side-effects. Secondly, some individuals in both groups (patch, gum) may benefit from either cessation or reduction in smoke exposure, as a result of the distinctly different mechanisms of the two treatments (steady state vs. intermittent delivery of NRT).

A.The primary objectives of this study are:

1. to evaluate the comparative safety of the nicotine transdermal system (21 mg "patch") and the nicotine gum (2 mg and 4 mg), dosed appropriately to pre-treatment levels of smoking, to initiate and sustain smoking cessation and reduction ;

2. to compare compliance levels with the patch and gum;

3. to evaluate the comparative efficacy of the patch and the gum to initiate and sustain smoking cessation and reduction;

4. to compare the rates of biochemically-verified continuous abstinence by using intent-to-treat analysis based on individual subject outcome.

B.The secondary objectives of this study are:

1. to correlate pre-treatment nicotine exposure (saliva cotinine) with withdrawal intensity measured in all groups during treatment and with treatment outcome;

2. to compare biological markers of smoke exposure (expired air CO and saliva thiocyanate) with self-reports of smoking and to correlate them with withdrawal symptomatology and treatment outcome;

3. to obtain smoking topography data (puff volume, velocity of intake, interpuff interval, and puffs per cigarette) on adolescent patterns of smoking as an index of smoking intensity and exposure and to correlate pre-treatment smoking intensity with treatment outcome.

C.The tertiary objectives are:

1. to examine the validity of the use of biochemical markers of smoke exposure (expired air CO and saliva thiocyanate) as potential markers of smoking cessation in adolescents;

2. to compare the relative cotinine exposure of adolescents who are smoking with those who are receiving nicotine replacement who do and do not successfully quit

Study Timeline

• Study Start: 1999-08
• Primary Completion: 2004-06
• Study Completion: 2004-08
• Status Verified: 2010-09
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-24
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Current use of tobacco or nicotine containing products other than cigarettes
• Previous use of any nicotine transdermal patch or nicotine gum
• Presence or history of severe skin allergies or dermatoses
• Pregnancy or lactation
• Active oral, dental or jaw mobility problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
c) Efficacy by Minnesota Withdrawal scale, craving visual analog scales and Questionnaire of Smoking Urges, smoking abstinence/reduction (as per self-reported data in smoking cessation diaries), expired air CO and saliva thiocyanate.
d) Weight and body mass index (BMI)
e)Cognitive performance tests

Trial Locations

Locations (1)

Teen Tobacco Addiction Research Clinic; 🇺🇸 Baltimore, Maryland, United States