CompletedPhase 2

A Pilot Study Evaluating Nicotine Lozenges and Self Help

United States60 participantsStarted 2008-04

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Tobacco Abstinence

Timeframe: 12 weeks

Trial details

NCT IDNCT00888459

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-04

Results submitted2010-10-04

View on ClinicalTrials.gov More Smokeless Tobacco Use trials