Bupropion SR Plus Counseling for Smoking Cessation

NCT01621009 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2016-01-27

Study results available
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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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Timothy B Baker, PhD · University of Wisconsin, Madison

  • Timothy B Baker, PhD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2002-10-31
Completion
2003-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621009 on ClinicalTrials.gov