NCT00414180

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
Last Updated

March 14, 2011

Status Verified

March 1, 2011

Enrollment Period

1.8 years

First QC Date

December 20, 2006

Last Update Submit

March 10, 2011

Conditions

Smokeless Tobacco

Outcome Measures

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

Interventions

Bupropion SRDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • used ST daily for at least one year
  • in good general health
  • willing to complete all study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lowell C. Dale, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 21, 2006

Study Start

August 1, 2003

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

March 14, 2011

Record last verified: 2011-03

Locations

US(1)