Combined Pharmaco/Behavior Therapy in Adolescent Smokers

To test the hypotheses, 216 adolescent smokers will be recruited. Fifty-four adolescent
smokers will be recruited in each of the four groups: bupropion SR only, bupropion SR + CM,
CM + placebo, and placebo only. The cells will be balanced for gender and attention deficit
hyperactivity disorder using permuted block randomization. A counseling intervention was
added for all groups because it was reasoned that it would be unethical not to provide an
active treatment to cigarette smoking adolescents. The counseling intervention will consist
of two quit smoking brochures that provide information on tips to help quit smoking.

The study will consist of a one-week lead in period followed by a six-week treatment trial.
For the medication groups, medications will be titrated during the one-week lead-in period.
The primary outcome measure is urine cotinine and self-report of cigarette use collected
using the Time-Line Follow-Back at the end of six weeks.

Inclusion Criteria:

1. Regular cigarette smokers smoking at least 5 cigarettes per day as derived by
Time-Line Follow-Back method (Sobell et al., 1988). Average number of cigarettes per
day (over past 30 days) will be used. Five cigarettes per day may seem low, but based
on previous studies, adolescents tend to smoke fewer cigarettes per day as compared to
adults.

2. Baseline urine cotinine level greater than 100 ng/ml.

3. Age range of 12 - 21

4. If under 18 yr. of age, parent(s) or guardian(s) able to participate in informed
consent and initial assessment, or the participant must provide evidence of
emancipated status.

5. For post menarchal female participants: agree to use birth control to avoid pregnancy.

Exclusion Criteria:

1. Active substance abuse/dependence (other than nicotine) within 2 weeks prior to
participating in the study

2. Lifetime bipolar affective disorder (BPAD), psychosis, eating disorders. Bupropion may
have adverse consequence on participants with these psychiatric diagnoses.

3. Current major depressive disorders. Since bupropion is also an antidepressant, this
criteria is to minimize the confound of depressive disorder during the study. History
of depressive disorders and current attention deficit hyperactivity disorder (ADHD)
will not be an exclusion. We will use permuted block randomization procedure to
balance the groups for ADHD.

4. Pregnancy or lactation. The safety of bupropion in pregnancy and during lactation is
not well studied.

5. History of seizure disorder or predisposition to seizures (e.g., history of
significant head trauma, currently taking medications that lower seizure threshold),
since bupropion can lower seizure threshold.

6. History of severe renal, hepatic, neurological, or chronic pulmonary disease. This
criterion was chosen due to the hepatic metabolism of bupropion.

7. Unstable medical problems

8. Allergy to bupropion

9. Current treatment with any other medication containing bupropion

10. Current treatment with any monoamine oxidase (MAO) inhibitors currently or within 2
weeks of starting the study since there may be serious and severe medical interactions
between MAO inhibitors and bupropion SR.

11. Current treatment with nicotine replacement therapy (NRT)

12. History of intolerance or non-response to bupropion SR.

13. Current (past month) suicide ideation

14. Suicide attempt (past year)