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Nicotine Lozenge to Reduce Smokeless Tobacco Use
This study has been completed.
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
University of Minnesota
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218283
  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 II

MedlinePlus related topics: Smokeless Tobacco
Drug Information available for: Nicotine polacrilex Nicotine tartrate Lobeline Lobeline sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Treatment of Smokeless Tobacco Users

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
1 - Nicotine Lozenge: Experimental
Use of nicotine lozenge plus behavioral counseling to help reduce tobacco use prior to quit date.
Drug: Nicotine Lozenge
Oral Nicotine replacement product
2 Behavioral counseling: Placebo Comparator
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218283

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota
  More Information

Responsible Party: University of Minnesota ( Dorothy Hatsukami )
Study ID Numbers: NIDA-14404-3, R01-14404-3, DPMC
Study First Received: September 16, 2005
Last Updated: June 27, 2008
ClinicalTrials.gov Identifier: NCT00218283  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
Nicotine Dependence
Tobacco Dependence

Study placed in the following topic categories:
Nicotine polacrilex
Lobeline
Nicotine
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009