Title
A Pilot Study Evaluating Nicotine Lozenges and Self Help
A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users
Phase
Phase 2Lead Sponsor
Mayo ClinicStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Smokeless Tobacco UseIntervention/Treatment
nicotine ...Study Participants
60The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.
4 mg nicotine lozenges, ad lib, for 12 weeks.
Placebo nicotine lozenges
Self-help counseling material and 4 mg nicotine lozenges
Inclusion Criteria: male; ≥18 years of age; report ST as their primary tobacco of use; have used ST daily for the past 6 months; indicate that they want to quit; have been provided with, understand, and have signed the informed consent. Exclusion Criteria: previously enrolled in a study involving the use of the nicotine lozenge; currently using or have completed using (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 PSVT; 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; have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.
| Event Type | Organ System | Event Term | Active | Placebo |
|---|
self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)
