Combined Pharmaco/Behavior Therapy in Adolescent Smokers

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00330187
• Date of registration: 25/05/2006
• Primary sponsor: Medical University of South Carolina
• Public title: Combined Pharmaco/Behavior Therapy in Adolescent Smokers
• Scientific title: Combined Pharmaco/Behavior Therapy in Adolescent Smokers
• Date of first enrolment: March 2004
• Target sample size: 216
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00330187
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Erin E EuDaly, BS, BA

• Name: Himanshu P Upadhyaya, MS, MBBS
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. Baseline urine cotinine level greater than 100 ng/ml.

3. Age range of 12 – 21

4. 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.

5. For post menarchal female participants: agree to use birth control to avoid
pregnancy.

Exclusion Criteria:

1. Active substance abuse/dependence (other than nicotine) within 2 weeks prior to
participating in the study

2. Lifetime bipolar affective disorder (BPAD), psychosis, eating disorders. Bupropion
may have adverse consequence on participants with these psychiatric diagnoses.

3. 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.

4. Pregnancy or lactation. The safety of bupropion in pregnancy and during lactation is
not well studied.

5. 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.

6. History of severe renal, hepatic, neurological, or chronic pulmonary disease. This
criterion was chosen due to the hepatic metabolism of bupropion.

7. Unstable medical problems

8. Allergy to bupropion

9. Current treatment with any other medication containing bupropion

10. 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.

11. Current treatment with nicotine replacement therapy (NRT)

12. History of intolerance or non-response to bupropion SR.

13. Current (past month) suicide ideation

14. Suicide attempt (past year)



Age minimum: 12 Years
Age maximum: 21 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Nicotine Dependence

Nicotine Use Disorder

Intervention(s)

Behavioral: Contingency Management

Drug: Bupropion SR

Primary Outcome(s)

self-report

urine cotinine

Secondary ID(s)

DA17460

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)