Combined Pharmaco/Behavior Therapy in Adolescent Smokers
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|ClinicalTrials.gov Identifier: NCT00330187|
Recruitment Status : Unknown
Verified April 2006 by Medical University of South Carolina.
Recruitment status was: Recruiting
First Posted : May 26, 2006
Last Update Posted : May 26, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence Nicotine Use Disorder||Drug: Bupropion SR Behavioral: Contingency Management||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||216 participants|
|Official Title:||Combined Pharmaco/Behavior Therapy in Adolescent Smokers|
|Study Start Date :||March 2004|
|Study Completion Date :||September 2008|
- urine cotinine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330187
|Contact: Erin E EuDaly, BS, BAfirstname.lastname@example.org|
|Contact: Ashley Leinbach, BAemail@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Himanshu P Upadhyaya, MS, MBBS||Medical University of South Carolina|