This trial, conducted from 2005 to 2007 in a single primary care setting, recruited 127 smokers from the local community in order to evaluate extended duration of a triplemedication combination versus standard-duration therapy with the nicotine patch alone and 6-month abstinence rates in smokers with medical illnesses; all were ≥18 years and had predefined medical illnesses. Participants were randomised to receive either the nicotine patch alone for a standard 10-week, tapering course (n=64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion ad libitum, for up to 6 months (n=63). Intention-to-treat analyses revealed abstinence rates at 26 weeks after target quit date of 35% for the combination group and 19% for the patch-alone group (p=0.040). The adjusted OR for abstinence in the combination group was 2.57 (p=0.041). The median time to relapse was significantly longer in the combination group than in the patch-alone group (65 days vs 23 days; p=0.005). Some side effects occurred more frequently in the combination group (for example, insomnia [25% vs 9%] and anxiety [22% vs 3%]), but the proportion of participants who discontinued study medications because of adverse events was similar in both groups (6%).
