|Grant Number:||5R01CA118035-05 Interpret this number|
|Primary Investigator:||Killen, Joel|
|Project Title:||Extended Cessation Treatment for Teen Smokers|
DESCRIPTION (provided by applicant): 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. 400 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. AN 400 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=200) 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=200) 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 25 week follow-up than participants receiving only open label treatment. PA at 25 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. 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. The proposed study will address several important gaps in our knowledge of how to help adolescent smokers quit smoking. First, to our knowledge, the study will be the first to examine the effects of a longer- lasting cessation program for adolescent smokers. Second, the study will be one of the first to combine psychological treatment and anti-smoking medication for adolescent smokers. Third, the trial will carefully examine a range of factors that may help or hinder adolescent smokers' ability to quit smoking. The study will provide important practical information to the medical and health communities concerning the usefulness of anti-smoking medication and psychological treatment in helping adolescent smokers to quit.