Bupropion SR for Treating Smokeless Tobacco Use - Full Text View

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 III

MedlinePlus related topics:

Smokeless Tobacco

Drug Information available for:

Bupropion hydrochloride Bupropion Lobeline Lobeline hydrochloride Lobeline sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Bupropion SR for Treating Smokeless Tobacco Use

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
Estimated Study Completion Date:	May 2005

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

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

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

Study placed in the following topic categories:

Lobeline

Dopamine

Bupropion

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Dopamine Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Pharmacologic Actions

Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Mayo Clinic West Virginia University
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00414180