COVACO: combineren van varenicline met counseling in de huisartsenpraktijk: een pragmatisch gerandomiseerd onderzoek

Background:

Behavioural support and pharmacotherapies can help smokers to stop smoking. Combining both treatment approaches is most effective and recommended in clinical guidelines. Varenicline is a new pharmacotherapy which has a different mechanism of action and appears to be more effective than some existing pharmacotherapies. In routine primary care, varenicline is often prescribed with brief general practitioner advice. The added value of combining varenicline with intensive counselling by a practice nurse is still unknown. Furthermore, the effectiveness of behavioural support and varenicline in primary care has not yet been investigated under real-life conditions.

Aim:

The primary aim of this study was to investigate whether intensive individual counselling delivered by a practice nurse in combination with varenicline is more effective in achieving biochemically validated prolonged abstinence from smoking in primary care patients than brief advice by the general practitioner in combination with varenicline.

Methods/Design:

A pragmatic randomized controlled trial was conducted comparing two intervention groups: (a) intensive individual counselling for smoking cessation delivered by a practice nurse combined with 12 weeks open-label varenicline and (b) brief advice for smoking cessation delivered by a general practitioner combined with 12-weeks open-label varenicline. A minimum of 272 adult daily smoking participants were recruited and treated in their routine primary care setting. The primary outcome was defined as prolonged abstinence from smoking from week 9 to 26 following treatment initiation, biochemically validated by exhaled carbon monoxide. Data was analysed blinded according to the intention-to-treat principle and participants with missing data on their smoking status at follow-up were counted as smokers. Secondary outcomes included: prolonged abstinence from week 9 to 52, short-term incremental cost-effectiveness, medication adherence, and baseline predictors of successful smoking cessation.