Comparing Smoking Treatment Programs for Lighter Smokers - 1

Verified by: National Institute on Drug Abuse (NIDA), June 2010
First Received: July 1, 2004 | Last Updated: June 16, 2010 | Phase: Phase 2 | Start Date: September 2003
Overall Status: Completed | Estimated Enrollment: 260
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The purpose of this study is to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling...

Brief Summary

Official Title: “Comparing Smoking Treatment Programs for Lighter Smokers”

The purpose of this study is to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

  • Drug: nicotine transdermal system
    • starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
  • Drug: bupropion
    • 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
  • Behavioral: Medication Management
    • Brief manual based therapy; four 15 minute session over 10 weeks.
  • Behavioral: Mayo Counseling
    • Manual based therapy; Weekly 30 minute sessions for 10 weeks
  • Drug: placebo patch
    • placebo patch containing no nicotine
  • Drug: placebo bupropion
    • placebo pills

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1: Bup+MM
    • bupropion and MM with placebo patch
  • Experimental: 2 bup+mayo
    • bupropion and Mayo counseling with placebo patch.
  • Experimental: 3 patch+mm
    • patch and MM with placebo pills
  • Experimental: 4 patch+mayo
    • patch and Mayo counseling with placebo patch

Outcome Measures for this Clinical Trial

Primary Measures

  • Completion of treatment and smoking cessation by two different types of medications and counseling types at 12, 26, and 52 weeks post-treatment initiation.
    • Time Frame: 52 weeks
      Safety Issue?: No

Secondary Measures

  • Delineate mediators associated with different treatment conditions (i.e., medication compliance, participant views of self-help written materials and counseling type.
    • Time Frame: 52 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

  • Light smokers (6-15 cigarettes per day

    • Inclusion Criteria:

    • Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day

    Exclusion Criteria:

    • Please contact site for more information

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: National Institute on Drug Abuse (NIDA) NIH

Overall Clinical Trial Officials and Contacts

Peter W Gariti, Ph.D. Principal Investigator University of Pennsylvania  

Related Publications

References

Gariti P, Levin S, Whittingham T, Barou D, Kampman KM, Lynch K, Halbert CH, Alterman A. Why do those who request smoking treatment fail to attend the first appointment? J Subst Abuse Treat. 2008 Jul;35(1):62-7. Epub 2007 Oct 10.

Citations Reporting Results

Gariti P, Lynch K, Alterman A, Kampman K, Xie H, Varillo K. Comparing smoking treatment programs for lighter smokers with and without a history of heavier smoking. J Subst Abuse Treat. 2009 Oct;37(3):247-55. Epub 2009 Mar 31.

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00086411

Study ID Number: NIDA-15365-1

ClinicalTrials.gov Identifier: NCT00086411

Health Authority: United States: Federal Government

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