Trial Information

Extended Cessation Treatment for Teen Smokers

Adolescent smokers (aged 14-18 years; > 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, the investigators 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.