Status:
COMPLETED
Combined Pharmaco/Behavior Therapy in Adolescent Smokers
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Dependence
Nicotine Use Disorder
Eligibility:
All Genders
12-21 years
Phase:
PHASE2
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 ...
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 pl...
Eligibility Criteria
Inclusion
- Regular cigarette smokers smoking at least 5 cigarettes per day as derived by Time-Line Follow-Back method (Sobell et al., 1988). Average number of cigarettes per day (over past 30 days) will be used. Five cigarettes per day may seem low, but based on previous studies, adolescents tend to smoke fewer cigarettes per day as compared to adults.
- Baseline urine cotinine level greater than 100 ng/ml.
- Age range of 12 - 21
- If under 18 yr. of age, parent(s) or guardian(s) able to participate in informed consent and initial assessment, or the participant must provide evidence of emancipated status.
- For post menarchal female participants: agree to use birth control to avoid pregnancy.
Exclusion
- Active substance abuse/dependence (other than nicotine) within 2 weeks prior to participating in the study
- Lifetime bipolar affective disorder (BPAD), psychosis, eating disorders. Bupropion may have adverse consequence on participants with these psychiatric diagnoses.
- Current major depressive disorders. Since bupropion is also an antidepressant, this criteria is to minimize the confound of depressive disorder during the study. History of depressive disorders and current attention deficit hyperactivity disorder (ADHD) will not be an exclusion. We will use permuted block randomization procedure to balance the groups for ADHD.
- Pregnancy or lactation. The safety of bupropion in pregnancy and during lactation is not well studied.
- History of seizure disorder or predisposition to seizures (e.g., history of significant head trauma, currently taking medications that lower seizure threshold), since bupropion can lower seizure threshold.
- History of severe renal, hepatic, neurological, or chronic pulmonary disease. This criterion was chosen due to the hepatic metabolism of bupropion.
- Unstable medical problems
- Allergy to bupropion
- Current treatment with any other medication containing bupropion
- Current treatment with any monoamine oxidase (MAO) inhibitors currently or within 2 weeks of starting the study since there may be serious and severe medical interactions between MAO inhibitors and bupropion SR.
- Current treatment with nicotine replacement therapy (NRT)
- History of intolerance or non-response to bupropion SR.
- Current (past month) suicide ideation
- Suicide attempt (past year)
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00330187
Start Date
March 1 2004
End Date
July 1 2009
Last Update
October 2 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425