Bupropion Alone or Combined With Nicotine Gum

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Timothy Baker, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01621022
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Focus of This Study Was to Determine if Bupropion Works Better for Smoking Cessation Alone or in Combination With Nicotine Gum as Needed.
Drug: bupropion + nicotine gum
Drug: Active bupropion-Placebo gum
Drug: Placebo bupropion-Placebo gum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Efficacy of Bupropion Alone and in Combination With Nicotine Gum

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 7-day point prevalence abstinence measured at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up


Enrollment: 608
Study Start Date: January 2001
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621022

Locations
United States, Wisconsin
UW Center for Tobacco Research and Intervention
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

Publications:
Responsible Party: Timothy Baker, Prinicipal Investigator, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01621022     History of Changes
Other Study ID Numbers: IRB S-01-07
Study First Received: June 13, 2012
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014