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Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

NCT01018394 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2013-09-13

Study results available
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Summary

Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.

Conditions

  • Tobacco Dependence

Interventions

DRUG

nicotine lozenges

4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.

DRUG

tobacco-free snuff

Tobacco-free snuff used ad lib for a maximum of 12 weeks

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Jon O Ebbert, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01018394 on ClinicalTrials.gov