Smokeless Tobacco Clinical Trial
Official title:
Bupropion SR for Treating Smokeless Tobacco Use
Verified date | March 2011 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | West Virginia University |
United States,
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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