Bupropion SR Plus Counseling for Smoking Cessation

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Timothy Baker, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01621009
First received: June 13, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Tobacco Dependence
Smoking
Drug: Active bupropion + counseling
Drug: Active bupropion, No counseling
Drug: Placebo medication + counseling
Drug: Placebo medication, No counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 7-day point prevalence abstinence from smoking at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.


Study Start Date: January 2001
Study Completion Date: October 2003
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active bupropion + counseling
Active bupropion SR plus eight 10-minute individual counseling sessions.
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.

Active Comparator: Active bupropion , No counseling
Active bupropion, No counseling, only medication checks
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

Placebo Comparator: Placebo medication + counseling
Placebo bupropion plus eight 10-minute individual counseling sessions
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.

Placebo Comparator: Placebo medication, No counseling
Placebo bupropion, No counseling, just medication checks
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

Drug: Placebo medication, No counseling
Other Names:
  • Pre-quit: Placebo medication once daily 7 days prior to quit day, then twice daily prior to quit day, then twice daily for 8 weeks after quit day.
  • Counseling: No counseling, just medication checks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621009

Locations
United States, Wisconsin
UW Center for Tobacco Research and Intervention
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Timothy B Baker, PhD University of Wisconsin, Madison
Study Director: Timothy B Baker, PhD University of Wisconsin, Madison
  More Information

Publications:
Responsible Party: Timothy Baker, Professor of Medicine, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01621009     History of Changes
Other Study ID Numbers: 1998-369, P50CA084724, P50DA19706
Study First Received: June 13, 2012
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
smoking cessation medications
smoking cessation counseling

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014