Nicotine Lozenge to Reduce Smokeless Tobacco Use

This study has been completed.
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218283
First received: September 16, 2005
Last updated: June 27, 2008
Last verified: June 2008
  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

Resource links provided by NLM:


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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 - Clinical and Translational Science Institute
Investigators
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 July 24, 2014