Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1

Among adolescents, the short-term health effects of smoking include damage to the
respiratory system, addiction to nicotine, and the associated risk of other drug use.
Adolescents are at greater risk for long-term health problems because most young people who
smoke regularly continue to smoke throughout adulthood. This study will compare the
effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting
the reduction of smoking in adolescent smokers. The study will also assess whether reduction
of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and
improved motivation to quit.

This open-label study will last a total of 6 weeks. Baseline measurements will be taken
twice a week at study visits for the first two weeks to assess vital signs and smoking
behavior. Participants will aslo use a computerized device outside of study visits to
monitor their own smoking habits. At Week 3, participants will be randomly assigned to
receive bupropion, a nicotine patch, nicotine gum, or placebo. Participants will be asked to
limit the frequency of their smoking to 75% of what it was during baseline. During Weeks 4,
5, and 6, participants will be expected to reduce smoking behavior to 50% of what it was at
baseline. Customized doses of nicotine patches and nicotine gum, relative to the amount of
cigarettes a participant smoked during baseline, will be dispensed weekly. Participants
receiving bupropion or placebo will receive medication at each study visit and will take one
pill daily. During treatment, study visits will occur once weekly. At each study visit, all
participants will receive a 10- to 15-minute standardized behavioral therapy session aimed
at supporting smoking reduction. Smoking habits and vital signs will be assessed and the
effects of the treatments will be determined. There will be one follow-up visit 3 months
post-intervention, at which time smoking status will be assessed.

Inclusion Criteria:

- At least 6 months of daily cigarette smoking

- No use of other tobacco products

- Motivated to reduce or quit smoking

- Not currently using medications to quit smoking

- Agree to use an effective form of contraception throughout the study

Exclusion Criteria:

- People for whom use of nicotine replacement therapy or bupropion is medically
inadvisable

- History of alcohol or drug abuse within 6 months of enrollment

- History of emotional problems (as assessed by the Adolescent Symptoms Inventory)
within 6 months prior to enrollment

- Currently on an unstable dose of psychoactive medications

- Currently taking medications that may react with one of the treatment medications

- Pregnant