The Use of Sibutramine in Smoking Cessation

西布曲明在戒烟中的应用

• 批准号: 6792040
• 负责人: KAREN C JOHNSON
• 金额: $ 52.76万
• 依托单位: UNIVERSITY OF TENNESSEE HEALTH SCI CTR
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6792040
• 关键词: anorexic agent; antidepressants; behavior test; behavioral /social science research tag; biological transport; body physical activity; body weight; clinical research; clinical trials; combination therapy; diet; drug abuse chemotherapy; human subject; human therapy evaluation; longitudinal human study; norepinephrine; obesity; outcomes research; patient oriented research; questionnaires; serotonin inhibitor; smoking; smoking cessation; tobacco abuse; transport inhibitor; weight gain

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).

吸烟带来严重但可预防的健康风险。 已经显示出行为戒烟干预措施，以帮助人们戒烟。 但是，据报道，人们担心体重增加，这是许多吸烟者退出的重大障碍。最近，西布替胺是一种新的5-羟色胺和去甲肾上腺素再摄取抑制剂，已获得FDA批准，以帮助人们减肥。 鉴于西布略胺对调节体重很重要的神经递质作用，可以合理地假设这种药物会减少戒烟的超重和肥胖吸烟者的过量后体重增加。 迄今为止，尚无临床试验将西布丁胺与安慰剂的使用进行比较，作为减少参加行为戒烟计划的超重和肥胖吸烟者中过度和肥胖的吸烟者的药物治疗。 因此，在未知的吸烟者中，西布丁胺是否有效地减少了过量后体重增加。 此外，鉴于西布塔明的神经药物作用，可以合理地推测这种药物也可以有效地帮助吸烟者最初和长期戒烟。我们假设使用西布略胺与使用安慰剂相比，使用西布略胺将导致超重和肥胖的人戒烟并导致戒烟率的提高，导致过重和肥胖的人的体重增加。 我们计划在这项双盲临床试验中检验这些假设，通过将吸烟的超重和肥胖的人随机化至两个组之一：第1组）西布塔明以及行为吸烟戒烟计划或第2组）安慰剂西布素和行为吸烟戒烟计划。 我们将最初（在治疗期间）和长期（随机分组后12个月，距研究药物减少9个月后），我们将确定结尾后体重的变化和戒烟。