MedTrace Logo

Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

NCT00717093 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2015-07-23

Study results available
· View outcomes & findings →

Summary

The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.

Conditions

  • Tobacco Use Cessation

Interventions

DRUG

Varenicline Tartrate

Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.

DRUG

Placebo

Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-04-30
Completion
2009-07-31

Countries

  • Norway
  • Sweden

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 NCT00717093 on ClinicalTrials.gov