Nicotine Lozenge 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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Use Disorder |
Drug: Nicotine Lozenge Behavioral: Behavioral Counseling |
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 |
- Reduction in tobacco use (measured by tobacco daily diary at Week 8, and the 12- and 26-week follow-up evaluations) [ Time Frame: 8, 12 and 26 weeks ] [ Designated as safety issue: No ]
- Toxicity profile of carcinogen metabolites (measured by urine screens at Week 8, and the 12- and 26-week follow-up evaluations) [ Time Frame: 8, 12 and 26 weeks ] [ Designated as safety issue: No ]
- Number of unsuccessful attempts to quit using tobacco (measured by tobacco use questionnaire at Week 8, and the 12- and 26-week follow-up evaluations) [ Time Frame: 8, 12 and 26 weeks ] [ Designated as safety issue: No ]
- Abstinence from tobacco (measured by tobacco use questionnaire at Week 8, and the 12- and 26-week follow-up evaluations) [ Time Frame: 8, 12 and 26 weeks ] [ Designated as safety issue: No ]
- Motivation and self-efficacy (measured by a questionnaire at Week 8, and the 12- and 26-week follow-up evaluations) [ Time Frame: 8, 12 and 26 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | January 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1 - Nicotine Lozenge
Use of nicotine lozenge plus behavioral counseling to help reduce tobacco use prior to quit date.
|
Drug: Nicotine Lozenge
Oral Nicotine replacement product
Other Name: Commite Nicotine lozenge
|
|
Placebo Comparator: 2 Behavioral counseling
Use of behavioral counseling alone to help reduce tobacco use prior to quit date.
|
Behavioral: Behavioral Counseling
Use of behavioral counseling to reduce tobacco use.
|
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. 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.
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
- 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
Contacts and Locations| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| 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: | NCT00218283 History of Changes |
| Other Study ID Numbers: | NIDA-14404-3, R01-14404-3, DPMC |
| Study First Received: | September 16, 2005 |
| Last Updated: | June 27, 2008 |
| 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 Nicotine polacrilex 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 Central Nervous System Stimulants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013