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 nicotine gum 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: Nicotine gum	Phase I Phase II

Further Study Details: 

Primary Outcomes: Percent reduction in use; Toxicity profile of carcinogen metabolites; Number of unsuccessful quit attempts; Abstinence
Secondary Outcomes: Motivation and self-efficacy

Spit tobacco presents as many health risks to its users as smoking tobacco. It affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of spit tobacco use include tooth abrasion, gum recession, mouth disease, bone-loss in the jaw, yellowing of teeth, and chronic bad breath. Although a significant number of smokeless tobacco (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 nicotine gum 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 in this open-label study will be randomly assigned to receive nicotine gum or placebo nicotine gum. All participants will be asked to alternate the use of their usual brand of ST with nicotine gum or placebo in order to reduce nicotine intake by 50% during the 1st four weeks and by 75% the following four weeks. 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. The number of participants who 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 12 and 26 weeks following the completion of treatment.

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 enrollment
• Has been using smokeless tobacco at least 6 times a day for 6 months prior to enrollment
• Agree to use an effective form of contraception throughout the study

Exclusion Criteria:

• Current use of other tobacco or nicotine products
• Pregnant or breastfeeding
• Any unstable medication 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 enrollment
• Use of any psychotropic medications within 6 months prior to enrollment

Please refer to this study by ClinicalTrials.gov identifier  NCT00218283

Joni Jensen, M.P.H.      (612)627-4903    jense010@umn.edu

Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States

Study chairs or principal investigators

Dorothy Hatsukami, Ph.D.,  Principal Investigator,  University of Minnesota   

Study ID Numbers:  NIDA-14404-3; R01-14404-3
Last Updated:  September 21, 2005
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00218283
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27