Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use
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Purpose
Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health risks associated with its use as cigarettes. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a standard tobacco cessation treatment program at reducing tobacco use in ST users.
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Use Disorder |
Drug: Smokeless Tobacco Reduction Treatment Drug: Standard Tobacco Cessation Treatment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Smokeless Tobacco Users |
- Abstinence from tobacco [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Duration of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Reduction in ST use (measured at Month 6) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Usual care (2 weeks nicotine patch)
|
Drug: Standard Tobacco Cessation Treatment
Nicotine patch
Other Name: Nicoderm
|
|
Experimental: 2
Reduction (6 weeks reduction prior to quit date) using nicotine lozenge or reduced nicotine smokeless tobacco.
|
Drug: Smokeless Tobacco Reduction Treatment
Reduction products
Other Name: Committ Lozenge, Skoal Bandits
|
Detailed Description:
Individuals who use ST are at risk for developing heart disease, stroke, high blood pressure, and cancer. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program at reducing tobacco use in ST users.
This 1-year study will enroll frequent users of ST. Participants will be randomly assigned to either a tobacco reduction program or a standard tobacco cessation program. Participants assigned to the tobacco reduction program will replace their usual brand of ST with one of two options: an ST brand with less concentrated nicotine, or tobacco free snuff. Participants will be encouraged to reduce their nicotine intake by at least 50% the first month and encouraged to further reduce their nicotine intake in the following months. Participants assigned to the standard tobacco cessation program will be advised to quit and will be asked to set a quit date. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided. Study visits will occur at 2,4,8,12,26 and 32 weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- No interest in stopping ST use within 90 days of study entry
- Using ST at least 6 times a day in the 6 months prior to study entry
- Willing to use contraception throughout the study
Exclusion Criteria:
- Current use of tobacco or nicotine products, other than ST
- Current unstable medical condition
- Meets DSM-IV diagnostic criteria for any psychiatric disorder or substance abuse disorder within 6 months of study entry
- Use of any psychotropic medication within 6 months of study entry
- Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
- Pregnant or breastfeeding
Contacts and Locations| United States, Minnesota | |
| Univerisity of Minnesota | |
| Minneapolis, Minnesota, United States, 55414 | |
| Principal Investigator: | Dorothy Hatsukami, PhD | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | Dorothy Hatsukami, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00218296 History of Changes |
| Other Study ID Numbers: | NIDA-14404-4, R01-DA14404-4, DPMCDA |
| Study First Received: | September 16, 2005 |
| Last Updated: | October 21, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
Nicotine Dependence Tobacco Dependence |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Lobeline Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013