The Use of Sibutramine in Smoking Cessation

吸烟会对健康造成严重的危害，但可以预防。 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重要障碍。最近，一种新的血清素和去甲肾上腺素再摄取抑制剂西布曲明已获得FDA批准，以帮助人们减肥。 考虑到西布曲明对调节体重的重要神经递质的影响，合理的假设是，这种药物将减少戒烟后超重和肥胖吸烟者的体重增加。 到目前为止，还没有临床试验比较西布曲明与安慰剂的使用，作为药物治疗，减少超重和肥胖吸烟者参加行为戒烟计划的戒烟后体重增加。 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，鉴于西布曲明的神经药理学作用，有理由推测这种药物也可以有效地帮助吸烟者戒烟，无论是最初还是长期。我们假设，与使用安慰剂相比，使用西布曲明将导致戒烟的超重和肥胖者戒烟后体重增加减少，并导致戒烟率增加。 我们计划在这项双盲临床试验中测试这些假设，将吸烟的超重和肥胖者随机分为两组：组1）西布曲明加行为戒烟计划或组2）安慰剂西布曲明加行为戒烟计划。 我们将确定最初（治疗期间）和长期（随机化后12个月，即停用研究药物9个月）戒烟后的体重变化和戒烟情况。

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).