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Use of Varenicline for 4-weeks Prior to Quitting

NCT00789074 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2013-12-12

Study results available
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Summary

Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard 1-week of use prior to stopping.

The study will recruit 100 smokers who want to stop. They will be randomly allocated to receive varenicline(4-weeks) or placebo (3-weeks followed by 1-week of active treatment as indicated by standard prescribing practice), followed by a 12-week open label treatment period where all participants will receive varenicline.

Conditions

  • Tobacco Dependence
  • Smoking Cessation

Interventions

DRUG

Varenicline

Varenicline 1mg twice daily

DRUG

Placebo

Placebo 1mg BD

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Al-Rehan A A Dhanji, MB BS BSc MRCP · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

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 NCT00789074 on ClinicalTrials.gov