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Extended Cessation Treatment for Teen Smokers

Phase 2/Phase 3
14 Years
18 Years
Not Enrolling
Cigarette Smoking

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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.

Inclusion Criteria:

- Age 14-18 years at the beginning of the study

- Smoking at least 10 cigarettes per day

- At least one quit attempt in previous 6 months

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

Type of Study:


Study Design:

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

Outcome Measure:

expired-air carbon monoxide confirmed abstinence

Outcome Description:

Abstinence is defined as a report of no smoking and CO level of less than 9PPM

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Joel D Killen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

June 2012

Related Keywords:

  • Cigarette Smoking
  • Smoking



Stanford University Stanford, California  94305
Stanford University School of Medicine Stanford, California  94305-5317