A Pilot Study Evaluating Nicotine Lozenges and Self Help

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Oregon Research Institute
• Treatments: Nicotine

Criteria

Inclusion Criteria:

1. male;

2. ≥18 years of age;

3. report ST as their primary tobacco of use;

4. have used ST daily for the past 6 months;

5. indicate that they want to quit;

6. have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

1. previously enrolled in a study involving the use of the nicotine lozenge;

2. currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;

3. currently enrolled in another research study;

4. 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;

5. have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU];

6. have another member of their household already participating in this study;

7. have other medical or psychiatric conditions that would exclude the participant;

8. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.