The Use of Sibutramine in Smoking Cessation

吸烟对健康有严重危害，但可以预防。行为戒烟干预已被证明有助于人们戒烟。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大障碍。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经获得美国食品和药物管理局的批准，可以帮助人们减肥。考虑到西布曲明对调节体重的重要神经递质有影响，我们有理由假设西布曲明会减少超重和肥胖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，作为药物治疗来减少超重和肥胖吸烟者戒烟后的体重增加，他们参加了行为戒烟计划。因此，西布曲明是否有效地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学作用，我们有理由推测，这种药物也可以有效地帮助吸烟者在最初和长期戒烟。我们假设，与使用安慰剂相比，使用西布曲明会导致超重和肥胖戒烟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测试这些假设，随机将超重和肥胖的吸烟者分为两组：第一组西布曲明加行为戒烟计划，第二组西布曲明加行为戒烟计划。我们将确定戒烟后的体重变化和戒烟的初期（治疗期间）和长期（随机分组后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).