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Bupropion SR Plus Counseling for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01621009
Recruitment Status : Completed
First Posted : June 15, 2012
Results First Posted : January 27, 2016
Last Update Posted : January 27, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE June 13, 2012
First Posted Date  ICMJE June 15, 2012
Results First Submitted Date  ICMJE May 27, 2015
Results First Posted Date  ICMJE January 27, 2016
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE January 2001
Actual Primary Completion Date October 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
7-day Point Prevalence Abstinence From Smoking at 6 Months [ Time Frame: 6 months ]
No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.
Original Primary Outcome Measures  ICMJE Same as current
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 Bupropion SR Plus Counseling for Smoking Cessation
Official Title  ICMJE A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
Brief Summary The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Tobacco Dependence
  • Smoking
Intervention  ICMJE
  • Drug: Active bupropion + counseling

    Medications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks.

    Counseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date.

  • Drug: Active bupropion, No counseling

    Medication - 150 mg bupropion per day starting week before quit day, then 150 mg twice daily 3 days before quit day, then 150 mg twice daily for eight weeks after quit day.

    Counseling: No cessation counseling, only medication checks

  • Drug: Placebo medication + counseling

    Placebo bupropion once daily 7 days before quit day, then twice daily 4 days before quit attempt, then twice daily for 8 weeks after quit day.

    Counseling: Two 10-minutes sessions before quit day, then eight 10-minutes sessions for eight weeks after quit day.

  • Drug: Placebo medication, No counseling

    Pre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day.

    Counseling: No counseling, just medication checks

Study Arms  ICMJE
  • Active Comparator: Active bupropion + counseling
    Active bupropion SR plus eight 10-minute individual counseling sessions.
    Intervention: Drug: Active bupropion + counseling
  • Active Comparator: Active bupropion , No counseling
    Active bupropion, No counseling, only medication checks
    Intervention: Drug: Active bupropion, No counseling
  • Placebo Comparator: Placebo medication + counseling
    Placebo bupropion plus eight 10-minute individual counseling sessions
    Intervention: Drug: Placebo medication + counseling
  • Placebo Comparator: Placebo medication, No counseling
    Placebo bupropion, No counseling, just medication checks
    Intervention: Drug: Placebo medication, No counseling
Publications * McCarthy DE, Piasecki TM, Lawrence DL, Jorenby DE, Shiffman S, Fiore MC, Baker TB. A randomized controlled clinical trial of bupropion SR and individual smoking cessation counseling. Nicotine Tob Res. 2008 Apr;10(4):717-29. doi: 10.1080/14622200801968343.

*   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: December 16, 2015)
463
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2003
Actual Primary Completion Date October 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Smoke 10 or more cigarettes per day
  • Expired carbon monoxide (CO) level greater than 9 parts per million (ppm)
  • Motivated to quit smoking (score of 3 on 4-point self-report scale)
  • Willing to fulfill study requirements

Exclusion Criteria:

  • Carbon monoxide breath test score below 9 ppm
  • Serious psychopathology (bipolar disorder, psychosis)
  • Center for Epidemiologic Studies Depression Scale CES-D)score over 16
  • Contraindications for use of bupropion
  • History of seizure disorder
  • History of eating disorder
  • Current heavy drinking
  • Risk of pregnancy
  • Current breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older 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 NCT01621009
Other Study ID Numbers  ICMJE 1998-369
P50CA084724 ( U.S. NIH Grant/Contract )
P50DA019706 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Timothy B Baker, PhD University of Wisconsin, Madison
Study Director: Timothy B Baker, PhD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date December 2015

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