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Combined Pharmaco/Behavior Therapy in Adolescent Smokers

Primary Purpose

Nicotine Dependence, Nicotine Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupropion SR
Contingency Management
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring nicotine dependence, bupropion SR, smoking cessation, adolescents, contingency management

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Criteria: 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)

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Bupropion SR + Contingency Management

Placebo + Contingency Management

Bupropion SR + No Contingency Management

Placebo + No Contingency Management

Arm Description

Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.

Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.

Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.

Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.

Outcomes

Primary Outcome Measures

Biologically-verified 7-day Point Prevalence Smoking Abstinence
Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL

Secondary Outcome Measures

Full Information

First Posted
May 25, 2006
Last Updated
September 7, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00330187
Brief Title
Combined Pharmaco/Behavior Therapy in Adolescent Smokers
Official Title
Combined Pharmaco/Behavior Therapy in Adolescent Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2004 (Actual)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Nicotine Use Disorder
Keywords
nicotine dependence, bupropion SR, smoking cessation, adolescents, contingency management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupropion SR + Contingency Management
Arm Type
Experimental
Arm Description
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Arm Title
Placebo + Contingency Management
Arm Type
Active Comparator
Arm Description
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Arm Title
Bupropion SR + No Contingency Management
Arm Type
Active Comparator
Arm Description
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Arm Title
Placebo + No Contingency Management
Arm Type
Placebo Comparator
Arm Description
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Intervention Type
Drug
Intervention Name(s)
Bupropion SR
Intervention Description
Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
Primary Outcome Measure Information:
Title
Biologically-verified 7-day Point Prevalence Smoking Abstinence
Description
Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL
Time Frame
End of treatment (week 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Himanshu P Upadhyaya, MS, MBBS
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20934835
Citation
Gray KM, Carpenter MJ, Baker NL, Hartwell KJ, Lewis AL, Hiott DW, Deas D, Upadhyaya HP. Bupropion SR and contingency management for adolescent smoking cessation. J Subst Abuse Treat. 2011 Jan;40(1):77-86. doi: 10.1016/j.jsat.2010.08.010. Epub 2010 Oct 8.
Results Reference
derived

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Combined Pharmaco/Behavior Therapy in Adolescent Smokers

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