NCT01621009

Bupropion SR Plus Counseling for Smoking Cessation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Dependence
• Smoking

Interventions

Type	Name	Description
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.
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
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.
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

Timeline

• Start date: 2001-01-01
• Primary completion: 2002-10-01
• Completion: 2003-10-01
• First posted: 2012-06-15
• Last updated: 2016-01-27
• Results posted: 2016-01-27

Locations

1 site across 1 country: United States