Nicotine Lozenge to Reduce Smokeless Tobacco Use
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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. 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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