Highdose Nicotine Patch Therapy for Smokeless Tobacco Use

NCT00939029 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2014-05-19

Study results available
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Summary

Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.

Conditions

  • Smokeless Tobacco Use

Interventions

DRUG

nicotine replacement therapy (nicotine patches)

2- 21 mg patches per day for 8 weeks

DRUG

placebo NRT

2 placebo patches (containing no active ingredient)per day for 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Jon O Ebbert, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-06-30
Completion
2013-06-30

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 NCT00939029 on ClinicalTrials.gov