Bupropion SR for Treating Smokeless Tobacco Use

Smokeless Tobacco Clinical Trial

Official title:

Bupropion SR for Treating Smokeless Tobacco Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414180
• Other study ID #: 06-007293
• Secondary ID: R01 9088
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2006
• Last updated: March 10, 2011
• Start date: August 2003
• Est. completion date: May 2005

Study information

• Verified date: March 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smokeless Tobacco

Intervention

Drug:
• Bupropion SR

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point-prevalence tobacco abstinence rate at week 12
Secondary	prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52