Bupropion SR for Treating Smokeless Tobacco Use - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2006

Last Updated Date

December 20, 2006

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

7-day point-prevalence tobacco abstinence rate at week 12

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Bupropion SR for Treating Smokeless Tobacco Use

Official Title ^ICMJE

Bupropion SR for Treating Smokeless Tobacco Use

Brief Summary

To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Smokeless Tobacco

Intervention ^ICMJE

Drug: Bupropion SR

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

225

Completion Date

May 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00414180

Responsible Party

Study ID Numbers ^ICMJE

06-007293, R01 9088

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

West Virginia University

Investigators ^ICMJE

Principal Investigator:

Lowell C. Dale, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

December 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP