Bupropion SR for Treating Smokeless Tobacco Use

This study has been completed.
Sponsor:
Collaborator:
West Virginia University
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00414180
First received: December 20, 2006
Last updated: March 10, 2011
Last verified: March 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT00414180

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
West Virginia University
Investigators
Principal Investigator: Lowell C. Dale, M.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00414180     History of Changes
Other Study ID Numbers: 06-007293, R01 9088
Study First Received: December 20, 2006
Last Updated: March 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Lobeline
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
Respiratory System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014