A Pilot Study Evaluating Nicotine Lozenges and Self Help

Phase 2

Completed

• Conditions: Smokeless Tobacco Use
• Interventions: Drug: placebo NRT; Drug: nicotine replacement therapy

• Registration Number: NCT00888459
• Lead Sponsor: Mayo Clinic

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 tobacco withdrawal.

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 (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-04
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Study Completion: 2009-05
• Results First Submitted: 2010-10-04
• Results First Submitted QC: 2010-10-04
• Results First Posted: 2010-11-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo NRT	self help counseling material and placebo nicotine lozenges
active	nicotine replacement therapy	Self-help counseling material and 4 mg nicotine lozenges

Primary Outcome Measures

Name	Time	Method
Number of Participants With Tobacco Abstinence	12 weeks	self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Oregon Research Institute; 🇺🇸 Eugene, Oregon, United States