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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218270 |
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 |
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Tobacco Use Disorder |
Drug: Tobacco free snuff |
Phase II |
Study Type: | Interventional |
Study Design: | Efficacy Study, Open Label, Parallel Assignment, Placebo Control, Randomized, Treatment |
Official Title: | Treatment of Smokeless Tobacco Users |
Enrollment: | 138 |
Study Start Date: | December 2002 |
Study Completion Date: | May 2005 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Reduction of tobacco use by substituting tobacco free snuff.
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Drug: Tobacco free snuff
Tobacco free snuff
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2: Placebo Comparator
Reduction of tobacco use by using behavioral techniques.
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Drug: Tobacco free snuff
Tobacco free snuff
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | UMN ( Dorohty Hatsukami ) |
Study ID Numbers: | NIDA-14404-2, DPMC, R01-14404-2 |
Study First Received: | September 16, 2005 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00218270 History of Changes |
Health Authority: | United States: Federal Government |
Smokeless tobacco, harm reduction |
Neurotransmitter Agents Lobeline Mental Disorders Nicotinic Agonists |
Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin Cholinergic Agents |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Tobacco Use Disorder Nicotinic Agonists Physiological Effects of Drugs Disorders of Environmental Origin Cholinergic Agents |
Pharmacologic Actions Lobeline Mental Disorders Autonomic Agents Therapeutic Uses Substance-Related Disorders Ganglionic Stimulants Peripheral Nervous System Agents |