Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation

Completed · Not applicable

Conditions studied: Smokeless Tobacco Cessation

In brief

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.

Key facts

Study ID

NCT01341938

Run by

Oregon Research Institute

People needed

1067

Starts

2011-07-01

Expected to finish

2012-11-01

Last updated by the study team

2021-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Oregon Research Insititute — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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