Nicotine Dependence Clinical Trial
Official title:
Combined Pharmaco/Behavior Therapy in Adolescent Smokers
In the current proposal, we intend to study the efficacy of bupropion SR with or without
combined contingency management (CM) among adolescent cigarette smokers. The proposed study
will test not only medication (bupropion SR), but also combination of medication and CM in
potentially improving smoking cessation outcomes AND retention of adolescent smokers in the
study.
Hypothesis to be tested: Bupropion SR treatment will increase abstinence from cigarette
smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as
compared to treatment with placebo only.
Hypothesis to be tested: Adolescent smokers treated with combined bupropion SR + contingency
management (CM) treatment will have increased retention and increased abstinence rates when
compared to bupropion SR alone or CM + placebo treated groups (as measured by decreased
drop-out of participants, urine cotinine and continuous abstinence).
Hypothesis to be tested: CM will increase the abstinence from cigarette smoking (as measured
by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment
with placebo only.
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.
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