Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions:

1. The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials

2. Assisted Self-Help intervention - self-help materials and phone counseling without lozenges

3. Lozenge Self Help intervention - self help materials and lozenge nicotine replacement therapy.

Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at 6 months among ST users who are interested in achieving tobacco abstinence, compared to those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Research Institute
• Collaborators: Mayo Clinic; National Cancer Institute (NCI)
• Treatments: Lobeline; Nicotine

Criteria

Inclusion Criteria:

• 18 years old or over

• Currently using smokeless tobacco products as primary tobacco product

• Use smokeless tobacco for the last 6 months

• Currently want to quit

• Able to read and write English; and

• Willing to share phone number, e-mail, and mailing address with the research project

• complete informed consent process

Exclusion Criteria:

• have used behavioral or pharmacologic tobacco treatment in last 30 days

• medical history of unstable angina, myocardial infarction within the past 6 months, cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT or medically treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic

• have phenylketonuria (PKU)

• have another member of their household already participating in this study

• currently pregnant or nursing

• score of ≥ 15 on the Patient Health Questionnaire (PHQ-8)