A Pilot Study Evaluating Nicotine Lozenges and Self Help

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.

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.