Use of Varenicline for 4-weeks Prior to Quitting

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Queen Mary University of London
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Smokers seeking treatment

• Aged 18 and over

• Consenting to take part in the trial

Exclusion Criteria:

• Pregnant or breastfeeding

• End-stage renal disease

• Used varenicline in the past 6 months

• Unable to fill in questionnaires in English

• Current psychiatric illness

• Current serious illness including uncontrolled hypertension and recent cardiac event

• Sensitivity to varenicline currently enrolled in other research projects.