Phase 3
N=81
Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction
Tobacco Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01018394 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Tobacco Abstinence at 12 Weeks — 8; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- nicotine lozenges (Drug); tobacco-free snuff (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tobacco Abstinence at 12 Weeks |
8; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
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: (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.
Data sourced from ClinicalTrials.gov (NCT01018394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.