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A Pilot Study Evaluating Nicotine Lozenges and Self Help

NCT00888459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-10-23

Study results available
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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.

Conditions

  • Smokeless Tobacco Use

Interventions

DRUG

nicotine replacement therapy

4 mg nicotine lozenges, ad lib, for 12 weeks.

DRUG

placebo NRT

Placebo nicotine lozenges

Sponsors & Collaborators

  • Oregon Research Institute

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Jon O Ebbert, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00888459 on ClinicalTrials.gov