Smokeless Tobacco
Conditions
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.
Interventions
DRUGBupropion SR
Sponsors
West Virginia University
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-day point-prevalence tobacco abstinence rate at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52 | — |
Countries
United States
Outcome results
None listed