Trial Information

Extended Cessation Treatment for Teen Smokers

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.