Bupropion SR for Treating Smokeless Tobacco Use

Mayo Clinic225 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

225

Conditions

Smokeless Tobacco

Interventions

Bupropion SRDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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