The Use of Sibutramine in Smoking Cessation

吸烟是一种严重但可以预防的健康风险。行为戒烟干预已被证明可以帮助人们戒烟。然而，据报道，对戒烟后体重增加的担忧是许多吸烟者戒烟的一个重要障碍。最近，一种新的5-羟色胺和去甲肾上腺素再摄取抑制剂西布曲明获得了FDA的批准，可以帮助人们减肥。鉴于西布曲明对调节体重很重要的神经递质的影响，有理由假设这种药物将减少超重和肥胖戒烟吸烟者戒烟后的体重增加。到目前为止，还没有临床试验比较西布曲明和安慰剂的使用，作为减少超重和肥胖吸烟者戒烟后体重增加的药物治疗，这些吸烟者参加了行为戒烟计划。因此，西布曲明是否能有效减少这些吸烟者戒烟后的体重增加尚不清楚。此外，考虑到西布曲明的神经药理作用，有理由推测这种药物在帮助吸烟者初步和长期戒烟方面也是有效的。我们假设，与使用安慰剂相比，使用西布曲明将导致超重和肥胖者戒烟后体重增加的减少，并导致戒烟率的增加。我们计划在这项双盲临床试验中通过将吸烟的超重和肥胖者随机分为两组：1)西布曲明加行为戒烟方案或2)安慰剂西布曲明加行为戒烟方案来检验这些假设。我们将确定戒烟后体重变化和戒烟的初期(治疗期间)和长期(随机化后12个月，即停止研究药物治疗9个月)。

Cigarette smoking poses a serious but preventable health risk. Behavioral smoking cessation interventions have been show to help persons quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting for many smokers. Recently, a new serotonin and norepinephrine reuptake inhibitor, sibutramine has received FDA approval to help persons lose weight. Given sibutramine effects neurotransmitters that are important in regulation of body weight, it is reasonable to hypothesize that this drug will decrease post-cessation weight gain in overweight and obese smokers who quit smoking. To date, there has been no clinical trial comparing use of sibutramine to a placebo, as pharmacologic therapy for reduction of post-cessation weight gain among overweight and obese smokers who take part in a behavioral smoking cessation program. Therefore, whether sibutramine is efficacious in reducing post-cessation weight gain in these smokers in unknown. Further, given the neuropharmacologic effects of sibutramine, it is reasonable to speculate that this medication could also be effective in helping smokers quit smoking both initially and long term. We hypothesize that use of sibutramine as compared to use of a placebo will result in a decrease in post-cessation weight gain in overweight and obese persons who quit smoking and result in an increase in smoking cessation rates. We plan to test these hypotheses in this double blind clinical trial by randomizing overweight and obese persons who smoke to one of two groups: Group 1) Sibutramine plus a behavioral smoking cessation program or Group 2) Placebo Sibutramine plus a behavioral smoking cessation program. We will determine post-cessation weight change and smoking cessation initially (during treatment) and long term (12 months after randomization, which is 9 months off study medication).