Combined Pharmaco/Behavior Therapy in Adolescent Smokers
2 other identifiers
interventional
134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 25, 2006
CompletedFirst Posted
Study publicly available on registry
May 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
October 2, 2018
CompletedOctober 2, 2018
September 1, 2018
5.3 years
May 25, 2006
September 7, 2018
September 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biologically-verified 7-day Point Prevalence Smoking Abstinence
Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL
End of treatment (week 6)
Study Arms (4)
Bupropion SR + Contingency Management
EXPERIMENTALBupropion 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 + Contingency Management
ACTIVE COMPARATORPlacebo 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 + No Contingency Management
ACTIVE COMPARATORBupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Placebo + No Contingency Management
PLACEBO COMPARATORPlacebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Interventions
Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (2)
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PMID: 37230961DERIVEDGray 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.
PMID: 20934835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kevin M. Gray, M.D.
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Himanshu P Upadhyaya, MS, MBBS
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 25, 2006
First Posted
May 26, 2006
Study Start
March 1, 2004
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
October 2, 2018
Results First Posted
October 2, 2018
Record last verified: 2018-09