Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/18/2017 |
| Start Date: | November 2006 |
| End Date: | January 2009 |
Treatment of Smokeless Tobacco Users
Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks
associated with its use. 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 usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in
ST users.
associated with its use. 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 usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in
ST users.
Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease.
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 (immediate
cessation) for reducing tobacco use in ST users.
This study will enroll regular users of ST. Participants will be randomly assigned to either
a tobacco reduction program or to usual care, a standard tobacco cessation program during the
first telephone contact. At the first clinic visit, participants assigned to the tobacco
Reduction Group will replace their usual brand of ST with one of two options: an ST brand
with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their
nicotine intake by at least 50% the first two weeks and encouraged to further reduce their
nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will
be advised to quit and will be asked to set a quit date within two weeks. Telephone
counseling, ideas on methods for sustaining cessation, and a self-help manual will also be
provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8,
12, 26, and 32 (for reduction group) 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.
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 (immediate
cessation) for reducing tobacco use in ST users.
This study will enroll regular users of ST. Participants will be randomly assigned to either
a tobacco reduction program or to usual care, a standard tobacco cessation program during the
first telephone contact. At the first clinic visit, participants assigned to the tobacco
Reduction Group will replace their usual brand of ST with one of two options: an ST brand
with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their
nicotine intake by at least 50% the first two weeks and encouraged to further reduce their
nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will
be advised to quit and will be asked to set a quit date within two weeks. Telephone
counseling, ideas on methods for sustaining cessation, and a self-help manual will also be
provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8,
12, 26, and 32 (for reduction group) 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.
Inclusion Criteria:
- No interest in stopping ST use within 90 days of study entry
- Daily use of ST in the 6 months prior to study entry
Exclusion Criteria:
- Current use of tobacco or nicotine products, other than ST
- Current unstable medical and mental health conditions
- Use of any medication that may affect tobacco use or be affected by a reduction in
tobacco use
- Pregnant or breastfeeding
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