Combined Pharmaco/Behavior Therapy in Adolescent Smokers
Condition: Nicotine Dependence; Nicotine Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Bupropion SR; Contingency Management; Placebo
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nicotine dependence; bupropion SR; smoking cessation; adolescents; contingency management