Status:
COMPLETED
A Pilot Study Evaluating Nicotine Lozenges and Self Help
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Oregon Research Institute
Conditions:
Smokeless Tobacco Use
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00888459
Start Date
April 1 2008
End Date
May 1 2009
Last Update
October 23 2023
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Oregon Research Institute
Eugene, Oregon, United States, 97403