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Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

NCT00392379 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2013-04-24

Study results available
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Summary

This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

Conditions

  • Smokeless Tobacco Use

Interventions

DRUG

Nicotine Lozenges

Nicotine lozenges, 4 mg

DRUG

Placebo lozenge

Placebo lozenge

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Jon O. Ebbert, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00392379 on ClinicalTrials.gov