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Extended Cessation Treatment for Teen Smokers

Phase 2/Phase 3
14 Years
18 Years
Not Enrolling
Nicotine Dependence

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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.

Inclusion Criteria:

Age 14-18 at the beginning of the study

Smoking at least 10 cigarettes per day

At least one quit attempt in previous 6mos

Exclusion Criteria:

Current DSM-IV disorder (depression, panic disorder, social anxiety disorder and

Current self report of daily or heavy use (more than three times per week) of any drugs
(marijuana, alcohol, cocaine, opiates, stimulants, etc.)

Positive urine pregnancy test

Currently on bupropion (Wellbutrin, Wellbutrin SR, Zyban) or other antidepressants,
MAOI's, antipsychotics, benzodiazepines

Currently on NRT

Currently receiving formal treatment for substance abuse problem, depression or anxiety

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

prolonged abstinence

Outcome Time Frame:

end of treatment, 6mos, 12mos

Safety Issue:


Principal Investigator

Joel D Killen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

July 2011

Related Keywords:

  • Nicotine Dependence
  • Tobacco Use Disorder



Stanford UniversityStanford, California  94305