ClinicalTrials.gov
ClinicalTrials.gov Menu

Bupropion Alone or Combined With Nicotine Gum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01621022
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : December 6, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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

Condition or disease Intervention/treatment Phase
Tobacco Dependence Drug: bupropion + nicotine gum Drug: Active bupropion-Placebo gum Drug: Placebo bupropion-Placebo gum Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 608 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy of Bupropion Alone and in Combination With Nicotine Gum
Study Start Date : January 2001
Actual Primary Completion Date : October 2002
Actual Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active bupropion-Active gum
150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day)
Drug: bupropion + nicotine gum
150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)
Active Comparator: Active bupropion-Placebo gum
150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day)
Drug: Active bupropion-Placebo gum
150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)
Active Comparator: Placebo medication-Placebo gum
Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day)
Drug: Placebo bupropion-Placebo gum
Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)



Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621022


Locations
United States, Wisconsin
UW Center for Tobacco Research and Intervention
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)

Publications of Results:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01621022     History of Changes
Other Study ID Numbers: IRB S-01-07
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016

Keywords provided by University of Wisconsin, Madison:
smoking cessation
tobacco dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors