Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use
Treatment of Smokeless Tobacco Users
3 other identifiers
interventional
138
1 country
1
Brief Summary
Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of smokeless tobacco (ST) include tooth abrasion, gum recession, mouth disease, loss of bone in the jaw, yellowing of teeth, and chronic bad breath. This study will assess the effectiveness of using tobacco free snuff in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedJanuary 10, 2017
June 1, 2008
2.4 years
September 16, 2005
January 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percent reduction in use
Week 8, 12, and 26
Toxicity profile of carcinogen metabolites
Week 8, 12, and 26
Number of unsuccessful quit attempts
Week 8, 12, and 26
Abstinence (measured at Weeks 8, 12, and 26)
Week 8, 12, and 26
Secondary Outcomes (1)
Motivation and self-efficacy (measured at Weeks 8, 12, and 26)
Week 8, 12, and 26
Study Arms (2)
1
EXPERIMENTALReduction of tobacco use by substituting tobacco free snuff.
2
PLACEBO COMPARATORReduction of tobacco use by using behavioral techniques.
Interventions
Eligibility Criteria
You may qualify if:
- Not interested in quitting smokeless tobacco use within 90 days of study entry
- Used smokeless tobacco at least six times a day for 6 months prior to study entry
- Agree to use an effective form of contraception throughout the study
You may not qualify if:
- Current use of tobacco or nicotine products other than ST
- Pregnant or breastfeeding
- Any unstable medical condition
- Use of any medication that may affect tobacco use or be affected by reduction of tobacco use
- DSM-IV diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry
- Use of any psychotropic medications within 6 months prior to study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorothy Hatsukami, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
December 1, 2002
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
January 10, 2017
Record last verified: 2008-06