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Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use

This study is not yet open for patient recruitment

Verified by National Institute on Drug Abuse (NIDA) February 2006

Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218270


Purpose

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.


Condition Intervention Phase
Tobacco Use Disorder Drug: Tobacco free snuff Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Treatment of Smokeless Tobacco Users

Further study details as provided by National Institute on Drug Abuse (NIDA):
Primary Outcomes: Percent reduction in use; Toxicity profile of carcinogen metabolites; Number of unsuccessful quit attempts; Abstinence (measured at Weeks 8, 12, and 26)
Secondary Outcomes: Motivation and self-efficacy (measured at Weeks 8, 12, and 26)
Expected Total Enrollment:  100

Study start: January 2006

Spit tobacco presents as many health risks to its users as smoking tobacco. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. However, approaches to help ST users reach this goal have not been studied. 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.

Participants will be randomly assigned to receive either treatment with tobacco-free snuff or treatment without it. All participants will be encouraged to reduce nicotine intake by 50% during the first four weeks and by 75% the following four weeks. Participants receiving the tobacco-free snuff will be asked to alternate the use of their usual brand of ST with tobacco-free snuff in order to achieve the targeted reduction. Participants not receiving the tobacco-free snuff will only be informed to try to cut down their tobacco use to the targeted reduction. Study visits will occur once weekly during the 8-week treatment period. Assessments will include vital signs, physiological measures related to tobacco use, and measures of motivation and self-efficacy to quit ST. The number of participants who either do not complete treatment, reduce nicotine intake, or quit completely will be assessed at the Week 8 study visit and at follow-up visits, which will be held at Weeks 12 and 26.

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00218270

Joni Jensen, MPH      612-627-4903    jense010@umn.edu

Minnesota
University of Minnesota, Minneapolis,  Minnesota,  55455,  United States
Joni Jensen, MPH  612-627-4903    jense010@umn.edu 

Study chairs or principal investigators

Dorothy Hatsukami, PhD,  Principal Investigator,  University of Minnesota   

More Information

Study ID Numbers:  NIDA-14404-2; R01-14404-2; DPMC
Last Updated:  March 6, 2006
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00218270
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-09-29





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