MedTrace Logo

Combined Pharmaco/Behavior Therapy in Adolescent Smokers

NCT00330187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2018-10-02

Study results available
· View outcomes & findings →

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.

Conditions

  • Nicotine Dependence
  • Nicotine Use Disorder

Interventions

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Himanshu P Upadhyaya, MS, MBBS · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00330187 on ClinicalTrials.gov