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Completed

NCT Number: NCT01621009

Bupropion SR Plus Counseling for Smoking Cessation

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.

Completed

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Key information

Conditions

Tobacco Dependence Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UW Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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, 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

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, 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

Primary outcomes

  1. 7-day Point Prevalence Abstinence From Smoking at 6 Months

    Time frame: 6 months

    No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2002
Study completion
2003
First posted
Jun 15, 2012
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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