Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330187
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2006-05-25
Brief Title:
Combined PharmacoBehavior Therapy in Adolescent Smokers
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Combined PharmacoBehavior Therapy in Adolescent Smokers
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA017460 | NIH | None | httpsreporternihgovquickSearchR01DA017460 |