CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 134 enrolled
Drug / intervention
Bupropion SR +2 moredrug
Likely dose
Bupropion SR 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00330187
NCT00330187Phase 2Completed

Combined Pharmaco/Behavior Therapy in Adolescent Smokers

Medical University of South Carolina·interventional·Posted May 26, 2006·Updated Oct 2, 2018

In Brief

A Phase 2 clinical trial evaluating Bupropion SR, Contingency Management, and 1 other intervention for Nicotine Dependence and Nicotine Use Disorder. Completed, enrolled 134 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2006
Enrollment StartMar 1, 2004
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.1 years ago

Interventions

Bupropion SRdrug

Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment

Contingency Managementbehavioral

Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.

Placeboother

Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment