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Bupropion SR for Treating Smokeless Tobacco Use

This study has been completed.
West Virginia University
Information provided by:
Mayo Clinic Identifier:
First received: December 20, 2006
Last updated: March 10, 2011
Last verified: March 2011
To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.

Condition Intervention Phase
Smokeless Tobacco
Drug: Bupropion SR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Bupropion SR for Treating Smokeless Tobacco Use

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 7-day point-prevalence tobacco abstinence rate at week 12

Secondary Outcome Measures:
  • prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52

Estimated Enrollment: 225
Study Start Date: August 2003
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Detailed Description:

CONTEXT: No pharmacotherapies have been shown to increase long-term (≥ 6 month) tobacco abstinence rates among smokeless tobacco (ST) users, although bupropion SR has demonstrated potential efficacy in pilot studies.

OBJECTIVE: To determine the efficacy and safety of bupropion SR for tobacco abstinence among ST users compared with placebo.

DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial conducted between August 2003 to May 2005 at two research centers with a 12-week treatment period and follow-up of smoking status to week 52.

INTERVENTION: Bupropion SR titrated to 150 mg twice daily or placebo for 12 weeks plus weekly behavioral interventions.

Main Outcome Measures: The primary endpoint was 7-day point-prevalence tobacco abstinence rate at week 12. Secondary outcomes included the prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52.


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

Inclusion Criteria:

  • 18 years of age or older
  • used ST daily for at least one year
  • in good general health
  • willing to complete all study procedures
  Contacts and Locations
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Please refer to this study by its identifier: NCT00414180

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
West Virginia University
Principal Investigator: Lowell C. Dale, M.D. Mayo Clinic
  More Information Identifier: NCT00414180     History of Changes
Other Study ID Numbers: 06-007293
R01 9088
Study First Received: December 20, 2006
Last Updated: March 10, 2011

Additional relevant MeSH terms:
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
Respiratory System Agents
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 processed this record on April 28, 2017