Use of Varenicline for 4-weeks Prior to Quitting

Effects of an Extended Period of Varenicline Use Prior to Quitting Smoking on Post-quitting Urges to Smoke

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.

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.