Status:
COMPLETED
Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the...
Detailed Description
This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial. Subjects will be randomized to the brand of smokeless tobacco that is determined to be most effective in S...
Eligibility Criteria
Inclusion
- smoking at least 10 cigarettes daily for the past year,
- in good physical health (no unstable medical condition;
- no contraindications for medicinal nicotine, as appropriate for the study, stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).
Exclusion
- Subjects must not be currently using other tobacco or nicotine products; Female subjects cannot be pregnant or nursing.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT00710034
Start Date
April 1 2010
End Date
May 1 2014
Last Update
December 6 2017
Active Locations (2)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
2
Oregon Research Institute
Eugene, Oregon, United States, 97403