Bupropion SR Plus Counseling for Smoking Cessation

NCT01621009 | Completed Phase 4 Results

• 3 other identifiers: 1998-369P50CA084724P50DA019706
• Study Type: interventional
• Target: 463
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence; Smoking

Keywords

smoking cessation medications; smoking cessation counseling

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Active bupropion + counseling

ACTIVE COMPARATOR

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

Drug: Active bupropion + counseling

Active bupropion , No counseling

ACTIVE COMPARATOR

Active bupropion, No counseling, only medication checks

Drug: Active bupropion, No counseling

Placebo medication + counseling

PLACEBO COMPARATOR

Placebo bupropion plus eight 10-minute individual counseling sessions

Drug: Placebo medication + counseling

Placebo medication, No counseling

PLACEBO COMPARATOR

Placebo bupropion, No counseling, just medication checks

Drug: Placebo medication, No counseling

Interventions

Active bupropion + counseling DRUG

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 + counseling

Active bupropion, No counseling DRUG

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

Active bupropion , No counseling

Placebo medication + counseling DRUG

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 + counseling

Placebo medication, No counseling DRUG

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

Placebo medication, No counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UW Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

Location

Related Publications (2)

• 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.

  PMID: 18418793 RESULT

• Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

  PMID: 37230961 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Counseling

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Lack of a no-treatment control condition; limited ability to generalize to broader population

Results Point of Contact

• Title: Timothy Baker, PhD, Director of Research
• Organization: University of Wisconsin Center for Tobacco Research and Intervention

tbb@ctri.wisc.edu

(608) 262-7568

Study Officials

• Timothy B Baker, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Timothy B Baker, PhD

  University of Wisconsin, Madison

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: January 1, 2001
• Primary Completion: October 1, 2002
• Study Completion: October 1, 2003
• Last Updated: January 27, 2016
• Results First Posted: January 27, 2016

Record last verified: 2015-12

Locations

US (1)