Bupropion SR Plus Counseling for Smoking Cessation

A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Tobacco Dependence
• Intervention / Treatment: Drug: Active bupropion + counseling; Drug: Active bupropion, No counseling; Drug: Placebo medication + counseling; Drug: Placebo medication, No counseling

• Study Type: Interventional
• Enrollment (Actual): 463
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53711
      • UW Center for Tobacco Research and Intervention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA); National Cancer Institute (NCI)
• Investigators: Principal Investigator: Timothy B Baker, PhD, University of Wisconsin, Madison; Study Director: Timothy B Baker, PhD, University of Wisconsin, Madison

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): October 1, 2002
• Study Completion (Actual): October 1, 2003

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: smoking cessation medications; smoking cessation counseling
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: 1998-369; P50CA084724 (U.S. NIH Grant/Contract); P50DA019706 (U.S. NIH Grant/Contract)