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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01208935
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : January 12, 2017
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Drug: Nicotine Patch Drug: Nicotine Gum Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence
Study Start Date : August 1999
Actual Primary Completion Date : June 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. a)Safety will be tabulated as a function of reported and observed adverse side-effects.
  2. 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.
  3. 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.
  4. d) Weight and body mass index (BMI)
  5. e)Cognitive performance tests

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01208935

United States, Maryland
Teen Tobacco Addiction Research Clinic
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Eric T. Moolchan, M.D. National Institutes on Drug Abuse IRP/ NIH


Responsible Party: Steve Heishman, NIDA IRP Identifier: NCT01208935     History of Changes
Other Study ID Numbers: NIDA-IRP-322
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: September 2010

Keywords provided by National Institute on Drug Abuse (NIDA):
Double blind

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action