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Completed

NCT Number: NCT01621022

Bupropion Alone or Combined With Nicotine Gum

Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.

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Key information

Conditions

Tobacco Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation 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
  • Motivated to quit
  • No physical or mental health issues that would prevent participation
  • Not pregnant or willing to prevent pregnancy during treatment

Exclusion criteria

  • Carbon monoxide (CO) breath test score below 10 parts per million (ppm)
  • Center for Epidemiologic Studies Depression Scale (CES-D) score greater than 16
  • Heavy alcohol use
  • History of eating disorder
  • Suicidality

Treatment and study plan

bupropion + nicotine gum

Drug

150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)

Active bupropion-Placebo gum

Drug

150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)

Placebo bupropion-Placebo gum

Drug

Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)

Primary outcomes

  1. 7-day point prevalence abstinence measured at 6 months

    Time frame: 6 months

    No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Efficacy of Bupropion Alone and in Combination With Nicotine Gum

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Jun 15, 2012
Registry last updated
Dec 6, 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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