Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Nicotine Lozenge
  • Oral Nicotine replacement product
• Behavioral: Behavioral Counseling
  • Use of behavioral counseling to reduce tobacco use.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1 - Nicotine Lozenge
  • Use of nicotine lozenge plus behavioral counseling to help reduce tobacco use prior to quit date.
• Placebo Comparator: 2 Behavioral counseling
  • Use of behavioral counseling alone to help reduce tobacco use prior to quit date.

Primary 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
    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
    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
    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
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Dorothy Hatsukami, PhD Principal Investigator University of Minnesota  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00218283

Study ID Number: NIDA-14404-3

ClinicalTrials.gov Identifier: NCT00218283

Health Authority: United States: Food and Drug Administration