Back to resultsComparing Smoking Treatment Programs for Lighter Smokers - 1
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nicotine transdermal system
bupropion
Medication Management
Mayo Counseling
placebo patch
placebo bupropion
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring light smokers, smoking cessation treatment programs
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
1: Bup+MM
2 Bup+Mayo
3 Patch+MM
4 Patch+Mayo
Arm Description
bupropion and MM counseling with placebo patch
bupropion and Mayo counseling with placebo patch.
patch and MM counseling with placebo pills
patch and Mayo counseling with placebo pills
Outcomes
Primary Outcome Measures
Percent Treatment Sessions Attended
Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model.
A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers.
Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.
Secondary Outcome Measures
Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.
Full Information
NCT ID
NCT00086411
First Posted
July 1, 2004
Last Updated
July 25, 2019
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00086411
Brief Title
Comparing Smoking Treatment Programs for Lighter Smokers - 1
Official Title
Comparing Smoking Treatment Programs for Lighter Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was 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. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.
Detailed Description
The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. The primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. The main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
light smokers, smoking cessation treatment programs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Bup+MM
Arm Type
Experimental
Arm Description
bupropion and MM counseling with placebo patch
Arm Title
2 Bup+Mayo
Arm Type
Experimental
Arm Description
bupropion and Mayo counseling with placebo patch.
Arm Title
3 Patch+MM
Arm Type
Placebo Comparator
Arm Description
patch and MM counseling with placebo pills
Arm Title
4 Patch+Mayo
Arm Type
Experimental
Arm Description
patch and Mayo counseling with placebo pills
Intervention Type
Drug
Intervention Name(s)
nicotine transdermal system
Other Intervention Name(s)
Nicoderm
Intervention Description
starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
Intervention Type
Drug
Intervention Name(s)
bupropion
Other Intervention Name(s)
Zyban
Intervention Description
150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
Intervention Type
Behavioral
Intervention Name(s)
Medication Management
Intervention Description
Brief manual based therapy; four 15 minute session over 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mayo Counseling
Intervention Description
Manual based therapy; Weekly 30 minute sessions for 10 weeks
Intervention Type
Drug
Intervention Name(s)
placebo patch
Intervention Description
placebo patch containing no nicotine
Intervention Type
Drug
Intervention Name(s)
placebo bupropion
Intervention Description
placebo pills
Primary Outcome Measure Information:
Title
Percent Treatment Sessions Attended
Description
Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model.
A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers.
Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter W Gariti, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104 6178
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17931823
Citation
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. doi: 10.1016/j.jsat.2007.08.009. Epub 2007 Oct 10.
Results Reference
background
PubMed Identifier
19339135
Citation
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. doi: 10.1016/j.jsat.2009.01.006. Epub 2009 Mar 31.
Results Reference
result
Learn more about this trial
Comparing Smoking Treatment Programs for Lighter Smokers - 1
We'll reach out to this number within 24 hrs