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Varenicline for the Treatment of Smokeless Tobacco

NCT00813917 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2012-07-16

Study results available
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Summary

Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially circumvents the limitations of using nicotine replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line of research is to develop effective pharmacologic treatments for ST users to increase long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that varenicline is efficacious for the treatment of ST users.

Conditions

  • Nicotine Dependence

Interventions

DRUG

varenicline

12 weeks of varenicline 1 mg by mouth twice per day

DRUG

placebo

12 weeks of placebo (double blinded) by mouth twice per day

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Jon O. Ebbert, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-10-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00813917 on ClinicalTrials.gov