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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


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
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