Status:

COMPLETED

Nicotine Lozenge to Reduce Smokeless Tobacco Use

Lead Sponsor:

National Institute on Drug Abuse (NIDA)

Collaborating Sponsors:

University of Minnesota

Conditions:

Tobacco Use Disorder

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief Summary

Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health risks associated with its use as cigarettes. While there are many treatment programs that focus on stopping to...

Detailed Description

Individuals who use ST are at risk for developing heart disease, stroke, high blood pressure, and cancer. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Ma...

Eligibility Criteria

Inclusion

  • No interest in stopping ST use within 90 days of study entry
  • Using ST at least 6 times a day in the 6 months prior to study entry
  • Willing to use contraception throughout the study

Exclusion

  • Current use of tobacco or nicotine products, other than ST
  • Current unstable medical condition
  • Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
  • Meets DSM-IV diagnostic criteria for any psychiatric disorder or substance abuse disorder within 6 months of study entry
  • Use of any psychotropic medication within 6 months of study entry
  • Pregnant or breastfeeding

Key Trial Info

Start Date :

January 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2007

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00218283

Start Date

January 1 2005

End Date

June 1 2007

Last Update

January 10 2017

Active Locations (1)

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1

University of Minnesota

Minneapolis, Minnesota, United States, 55455