Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

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
    

Intervention name(s): Nicotine Patch; Nicotine Gum
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Randomized; Double blind; double-dummy; placebo-controlled