Combined Pharmaco/Behavior Therapy in Adolescent Smokers
Condition: Nicotine Dependence; Nicotine Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Bupropion SR; Contingency Management; Placebo
Intervention description: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment; Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.; Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 134.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine dependence; bupropion SR; smoking cessation; adolescents; contingency management

Summary:

      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.
    

Eligibility criteria:

        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)