Conditions: Tobacco Dependence Smoking Cessation
Keywords: Smoking cessation Tobacco dependence Varenicline Preloading
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 101
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Participants will use varenicline (1mg BD) 4-weeks prior to quitting arm 2: Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting

Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: Varenicline 1mg twice daily intervention 2: Placebo 1mg BD

Protocol document: