NCT00330187

Combined Pharmaco/Behavior Therapy in Adolescent Smokers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nicotine Dependence
• Nicotine Use Disorder

Interventions

Type	Name	Description
DRUG	Bupropion SR	Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
BEHAVIORAL	Contingency Management	Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
OTHER	Placebo	Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment

Timeline

• Start date: 2004-03-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2006-05-26
• Last updated: 2018-10-02
• Results posted: 2018-10-02

Locations

1 site across 1 country: United States