Bupropion SR as an aid to smoking cessation in smokers treated previously with bupropion: A randomized placebo-controlled study

Background: Many persons who attempt to quit smoking have made previous uns uccessful attempts to quit with pharmacologic aids. An understanding of the impact of these previous attempts to quit is vital for selecting medicatio ns that may be more successful in a future attempt to quit. In particular, the effect of repeated use of bupropion SR (Zyban; INN, amfebutamone) on ab stinence rates has not been studied previously. Methods: This was a multicenter, randomized, double-blind, placebo-controll ed study in 450 smokers who had previously used bupropion in a smoking cess ation attempt. The study consisted of a screening phase, a 12-week treatmen t phase, and a follow-up at month 6. Participants made regular clinic visit s throughout the treatment phase during which they received brief counselin g sessions to encourage abstinence from smoking. The primary end point was continuous abstinence from smoking from weeks 4 through 7. Secondary effica cy end points were examined throughout the treatment phase and at follow-up after 6 months. Results: In participants receiving bupropion SR, 27% (61 of 226) remained a bstinent throughout the period from weeks 4 through 7 compared with 5% (11 of 224) of participants receiving placebo (P < .001). Significantly (P < .0 01) more participants who received bupropion SR during the treatment phase remained continuously abstinent from the start of week 4 through month 6 (2 7 of 226; 12%) compared with participants who received placebo (5 of 224; 2 %). Eleven participants receiving placebo (5%) and 19 participants receivin g bupropion SR (8%) stopped taking the study medication because of an adver se event. Conclusions: Bupropion SR is an effective medication for retreatment of smo kers who have used bupropion SR previously.