Extended Cessation Treatment for Teen Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to test the efficacy of an extended smoking cessation program for teen
      smokers. We hypothesize that teen smokers randomized to extended treatment will have a higher
      abstinence rate at 52 week follow-up than teen smokers receiving only open label treatment.
    

Detailed description: 
      Adolescent smokers (aged 14-18; > 10 cigarettes/day) attending continuation high schools in
      the San Francisco-San Jose Bay Area will serve as the target population for this study. 280
      smokers meeting eligibility criteria will be randomized. Our primary goal is to examine the
      effectiveness of a multi-factor extended treatment strategy in promoting longer-term smoking
      abstinence. All 280 smokers will receive 10 weeks of open label treatment consisting of
      nicotine patch therapy and group-based, intensive self-regulatory skills training (ST).
      Following open label treatment, half (n=140) will receive nine additional group-based ST
      sessions delivered over a 14 week period. Telephone counseling will also be provided in
      conjunction with an Interactive Voice Response system (IVR) that will allow early detection
      of smoking "slips" and rapid response by treatment staff. The other half (n=140) will not
      receive any additional therapy beyond that provided in the open label treatment phase.
      Abstinence and relapse will be assessed at the end of open label (10 weeks) and extended
      treatment (24 weeks) and at 52 weeks from the time of study entry. Our primary hypothesis is
      that smokers randomized to extended treatment will have a higher prolonged abstinence rate
      (PA) at 52 week follow-up than participants receiving only open label treatment. PA at 52
      weeks will be the outcome measure used to evaluate the primary hypothesis and will be defined
      as a report of non-smoking following an initial 2-week grace period during which any smoking
      is not counted as a failure and an expired-air carbon monoxide level of <9PPM. Here, failure
      is defined as either seven consecutive days of smoking or smoking on at least one day on each
      of two consecutive weeks. Point prevalence abstinence will be examined as a secondary outcome
      and defined as no smoking, not even a puff, for seven consecutive days prior to assessment
      and an expired-air carbon monoxide level of <9PPM. With 150 participants per cell, we will
      have, in general, 80% power at a 2-tailed alpha of .05 to detect a difference in abstinence
      rates of at least 15% over a large range of success probabilities.
    

Intervention name(s): Extended treatment
Intervention type(s): Drug
Intervention description(s): All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.
Other intervention name(s): CBT; nicotine patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment