Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

Completed · Phase 2/Phase 3

Conditions studied: Tobacco Dependence

In brief

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.

Key facts

Study ID

NCT01018394

Run by

Mayo Clinic

People needed

81

Starts

2009-01-01

Expected to finish

2012-07-01

Last updated by the study team

2013-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• at least 18 years of age;
• no intention of quitting in the next one month;
• report ST as their primary tobacco of use;
• have used ST daily for the past 12 months;
• have been provided with, understand, and have signed the informed consent
• are able to complete all study visits;
• are in general good health as determined by medical history.

You may not qualify if…

• 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: (a) unstable angina; (b) myocardial infarction within the past 6 months; (c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or paroxysmal supraventricular tachycardia; or (d) 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];
• have another member of their 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;
• are currently pregnant are trying to become pregnant;
• are currently breast-feeding and unwilling to stop during this study.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Oregon Research Institute — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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