Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

暴饮暴食症（BED）是最常见的正式饮食失调，与肥胖密切相关， 生物心理社会障碍需要改善BED肥胖患者的治疗方法， 持续的临床结果和促进减肥。此更新应用程序建立在以前的项目。 本研究旨在进行两阶段随机对照试验，以测试行为减肥（BWL）的有效性 以及用纳洛酮/安非他酮（NB;最近FDA批准的抗肥胖药）的药物治疗 组合药物），单独和组合，用于治疗肥胖患者的BED。第一阶段 RCT将提供关于NB药物有效性的新发现，以及这种特异性 BWL和NB联合用药对BED肥胖患者有效。第二阶段RCT将 在第1阶段的应答者中，从对照试验中提供新的发现， 在上级维持治疗和短期结局方面优于安慰剂。第二阶段RCT还将探索使用 在第1阶段治疗无应答者中进行对照试验， (CBT)增强正在进行的药物治疗（NB/安慰剂）。 在第1阶段RCT中，N=160例BED肥胖患者将被随机分配（双盲）， 平衡析因（2 × 2）设计试验，分为4种16周干预措施：BWL+NB、BWL+安慰剂、NB或 安慰剂。在第2阶段RCT中，第1阶段治疗的“应答者”（定义为暴食减少65%或以上） 进食）将以相同比例随机化（分层区组随机化，第1阶段治疗为 分层变量）至NB或安慰剂（双盲），持续16周。第1阶段治疗的“无应答者”将 继续进行药物治疗（NB/安慰剂;双盲），其中50%随机接受CBT。 独立的评估人员将对暴饮暴食和肥胖以及他们的行为进行全面的评估。 通过12个月随访的相关结果（即，初始随机化后20个月）。 这项研究将产生关于BWL的相对疗效的重要新信息， FDA批准的抗肥胖NB药物）单独或联合用于肥胖患者的卧床治疗。本研究将 产生关于初始急性治疗的应答者中，NB 与安慰剂相比，药物治疗导致上级维持和更长期的结果。这项研究将产生 关于结果的预测因子、调节因子和介导因子的重要发现， 医学指导处方和进一步完善治疗。最后，本研究将产生新颖的 关于在初始急性治疗的无应答者中，添加CBT是否能增强 药物治疗的结果。

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for obese patients with BED are needed that can produce sustained clinical outcomes and promote weight loss. This renewal application builds on previous project. This study aims to perform a two-stage RCT to test the effectiveness of behavioral weight loss (BWL) and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved anti-obesity combination medication), alone and in combination, for the treatment of BED in obese patients. The first stage RCT will provide new findings regarding the effectiveness of NB medication and whether this specific combination of BWL and NB medication is effective for obese patients with BED. The second stage RCT will provide novel findings from a controlled test, amongst Responders to Stage 1, whether NB medication results in superior maintenance and lower-term outcomes than placebo. The second stage RCT will also explore using a controlled test, amongst Non-responders to Stage 1 treatment, whether adding cognitive-behavioral therapy (CBT) enhances on-going pharmacotherapy (NB/placebo). In Stage 1 RCT, N=160 obese patients with BED will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. In Stage 2 RCT, “Responders” to Stage 1 treatments (defined as 65% or greater reduction in binge eating) will be randomized in equal proportions (stratified blocked randomization with Stage 1 treatment as stratifying variable) to NB or placebo (double-blind) for 16 weeks. “Non-responders” to Stage 1 treatments will continue on-going pharmacotherapy (NB/placebo; double-blind) with 50% randomized to also receive CBT. Independent evaluators will perform comprehensive assessments of both binge eating and obesity and their associated outcomes through 12-month follow-ups (i.e., 20 months after initial randomization). This study will produce important new information about the relative efficacy of BWL and this recently FDA-approved anti-obesity NB medicine), alone and in combination, for BED in obese patients. This study will produce new and novel information regarding whether amongst Responders to initial acute treatments, NB medication results in superior maintenance and longer term outcomes than placebo. This study will produce important findings regarding predictors, moderators, and mediators of outcomes that have implication for empirically-guided prescription and further refinement of treatments. Finally, this study will produce novel information regarding whether amongst Non-responders to initial acute treatments, adding CBT enhances on- going pharmacotherapy outcomes.