A Study Comparing Nicotine Lozenges to Tobacco-Free Snuff for Reducing the Use of Smokeless Tobacco

Overview

About this study

The purpose of this study is to to develop a Smokeless Tobacco (ST) reduction intervention among ST users not interested in quitting tobacco. The first step is to assess the effectiveness of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria

  • Age at least 18 years
  • No intention of quitting in the next one month
  • Report Smokeless Tobacco as  primary tobacco of use
  • Have used ST daily for the past 12 months
  • Have been provided with, understand, and have signed the informed consent
  • Able to complete all study visits
  • In general good health as determined by medical history

Exclusion Criteria

  • Currently using or have used (within the past 30 days) any other behavioral or pharmacologic tobacco treatment program
  • Currently enrolled in another research study
  • Describe having a medical history of
    • Unstable angina
    • Myocardial infarction within the past 6 months
    • Cardiac dysrhythmia other than medication-controlled atrial fibrillation or paroxysmal supraventricular tachycardia
    • Medically-treated or untreated hypertension with BP ≥ 180 systolic or ≥ 100 diastolic
  • Have phenylketonuria (PKU)
    • Nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU
  • Another member of the household already participating in this study
  • Have other medical or psychiatric conditions that would exclude the participant in the opinion of the investigators
  • Have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-8) on the phone call pre-screen
  • Currently pregnant
  • Trying to become pregnant
  • Currently breast-feeding and unwilling to stop during this study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Jon Ebbert, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20315194

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