Bupropion SR Plus Counseling for Smoking Cessation

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621009
• Other study ID #: 1998-369
• Secondary ID: P50CA084724P50DA
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2012
• Last updated: December 16, 2015
• Start date: January 2001
• Est. completion date: October 2003

Study information

• Verified date: December 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: October 2003
• Est. primary completion date: October 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking
• Tobacco Dependence

Intervention

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 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 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 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

Locations

Country	Name	City	State
United States	UW Center for Tobacco Research and Intervention	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No