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Bupropion SR Plus Counseling for Smoking Cessation

Primary Purpose

Tobacco Dependence, Smoking

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Active bupropion + counseling
Active bupropion, No counseling
Placebo medication + counseling
Placebo medication, No counseling
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring smoking cessation medications, smoking cessation counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UW Center for Tobacco Research and Intervention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Active bupropion + counseling

Active bupropion , No counseling

Placebo medication + counseling

Placebo medication, No counseling

Arm Description

Active bupropion SR plus eight 10-minute individual counseling sessions.

Active bupropion, No counseling, only medication checks

Placebo bupropion plus eight 10-minute individual counseling sessions

Placebo bupropion, No counseling, just medication checks

Outcomes

Primary Outcome Measures

7-day Point Prevalence Abstinence From Smoking at 6 Months
No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.

Secondary Outcome Measures

Full Information

First Posted
June 13, 2012
Last Updated
December 16, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01621009
Brief Title
Bupropion SR Plus Counseling for Smoking Cessation
Official Title
A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence, Smoking
Keywords
smoking cessation medications, smoking cessation counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
463 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active bupropion + counseling
Arm Type
Active Comparator
Arm Description
Active bupropion SR plus eight 10-minute individual counseling sessions.
Arm Title
Active bupropion , No counseling
Arm Type
Active Comparator
Arm Description
Active bupropion, No counseling, only medication checks
Arm Title
Placebo medication + counseling
Arm Type
Placebo Comparator
Arm Description
Placebo bupropion plus eight 10-minute individual counseling sessions
Arm Title
Placebo medication, No counseling
Arm Type
Placebo Comparator
Arm Description
Placebo bupropion, No counseling, just medication checks
Intervention Type
Drug
Intervention Name(s)
Active bupropion + counseling
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Active bupropion, No counseling
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo medication + counseling
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo medication, No counseling
Intervention Description
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
Primary Outcome Measure Information:
Title
7-day Point Prevalence Abstinence From Smoking at 6 Months
Description
No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy B Baker, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy B Baker, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Director
Facility Information:
Facility Name
UW Center for Tobacco Research and Intervention
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18418793
Citation
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.
Results Reference
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Bupropion SR Plus Counseling for Smoking Cessation

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