Nicotine Lozenge to Reduce Smokeless Tobacco Use
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/11/2017 |
| Start Date: | January 2005 |
| End Date: | June 2007 |
Treatment of Smokeless Tobacco Users
Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health
risks associated with its use as cigarettes. While there are many treatment programs that
focus on stopping tobacco use, there are no interventions that specifically focus on
reducing tobacco use. This study will evaluate the effectiveness of nicotine lozenge at
reducing tobacco use in ST users.
risks associated with its use as cigarettes. While there are many treatment programs that
focus on stopping tobacco use, there are no interventions that specifically focus on
reducing tobacco use. This study will evaluate the effectiveness of nicotine lozenge at
reducing tobacco use in ST users.
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. The need exists for a program specifically aimed
towards reducing, rather than quitting, tobacco use. The purpose of this study is to
evaluate the effectiveness of nicotine gum at reducing ST use, as well as assessing the
motivation to either quit or sustain lower levels of ST use.
This 8-week study will enroll frequent users of ST. Participants will be randomly assigned
to receive either nicotine lozenge plus behavioral counseling or behavioral counseling
alone. All participants will be asked to alternate use of their usual ST brand with nicotine
lozenge or placebo in order to reduce nicotine intake by 50% during the first 4 weeks and by
75% the following 4 weeks. Participants will be required to maintain a daily tobacco use
diary. Study visits will occur once a week. Tobacco levels will be monitored with urine
tests, and questionnaires will be completed to assess tobacco use. Follow-up evaluations
will occur 12 and 26 weeks following the end of treatment.
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. The need exists for a program specifically aimed
towards reducing, rather than quitting, tobacco use. The purpose of this study is to
evaluate the effectiveness of nicotine gum at reducing ST use, as well as assessing the
motivation to either quit or sustain lower levels of ST use.
This 8-week study will enroll frequent users of ST. Participants will be randomly assigned
to receive either nicotine lozenge plus behavioral counseling or behavioral counseling
alone. All participants will be asked to alternate use of their usual ST brand with nicotine
lozenge or placebo in order to reduce nicotine intake by 50% during the first 4 weeks and by
75% the following 4 weeks. Participants will be required to maintain a daily tobacco use
diary. Study visits will occur once a week. Tobacco levels will be monitored with urine
tests, and questionnaires will be completed to assess tobacco use. Follow-up evaluations
will occur 12 and 26 weeks following the end of treatment.
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
- Use of any medication that may affect tobacco use or be affected by a reduction in
tobacco use
- 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
- Pregnant or breastfeeding
We found this trial at
1
site
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
Click here to add this to my saved trials
