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Combined Pharmaco/Behavior Therapy in Adolescent Smokers

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ClinicalTrials.gov Identifier: NCT00330187
Recruitment Status : Completed
First Posted : May 26, 2006
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE May 25, 2006
First Posted Date  ICMJE May 26, 2006
Results First Submitted Date  ICMJE September 7, 2018
Results First Posted Date  ICMJE October 2, 2018
Last Update Posted Date October 2, 2018
Actual Study Start Date  ICMJE March 2004
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
Biologically-verified 7-day Point Prevalence Smoking Abstinence [ Time Frame: End of treatment (week 6) ]
Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2006)
  • urine cotinine
  • self-report
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Pharmaco/Behavior Therapy in Adolescent Smokers
Official Title  ICMJE Combined Pharmaco/Behavior Therapy in Adolescent Smokers
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nicotine Dependence
  • Nicotine Use Disorder
Intervention  ICMJE
  • Drug: Bupropion SR
    Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
  • Behavioral: Contingency Management
    Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
  • Other: Placebo
    Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
Study Arms  ICMJE
  • Experimental: Bupropion SR + Contingency Management
    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.
    Interventions:
    • Drug: Bupropion SR
    • Behavioral: Contingency Management
  • Active Comparator: Placebo + Contingency Management
    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.
    Interventions:
    • Behavioral: Contingency Management
    • Other: Placebo
  • Active Comparator: Bupropion SR + No Contingency Management
    Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.
    Intervention: Drug: Bupropion SR
  • Placebo Comparator: Placebo + No Contingency Management
    Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.
    Intervention: Other: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2018)
134
Original Enrollment  ICMJE
 (submitted: May 25, 2006)
216
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00330187
Other Study ID Numbers  ICMJE DA17460
R01DA017460 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kevin Gray, MD, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Himanshu P Upadhyaya, MS, MBBS Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP