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Completed

NCT Number: NCT00414180

Bupropion SR for Treating Smokeless Tobacco Use

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

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Key information

Conditions

Smokeless Tobacco Behavior Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupropion SR

Drug

Primary outcomes

  1. 7-day point-prevalence tobacco abstinence rate at week 12

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • West Virginia University

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Dec 21, 2006
Registry last updated
Mar 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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