Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

暴饮暴食障碍(Bed)是最普遍的正式饮食障碍，与肥胖和 生物心理社会损害。需要改善肥胖症患者的卧床治疗，以产生 持续的临床结果和促进减肥。此续订申请建立在以前项目的基础上。 本研究旨在进行两阶段随机对照试验，以测试行为减肥的有效性。 以及纳曲酮/安非他酮(NB；一种最近获得FDA批准的减肥药物)的药物治疗 联合用药)，单独或联合治疗肥胖症患者的床上。第一阶段 RCT将提供关于NB药物有效性的新发现，以及这一特定的 BWL和NB联合用药对卧床的肥胖患者有效。第二阶段RCT将 在阶段1的应答者中提供来自受控试验的新发现，无论NB药物治疗是否结果 在更好的维持和比安慰剂更低的长期疗效方面。第二阶段RCT还将探索使用 一项对照测试，在对第一阶段治疗无效的患者中，是否加入认知行为治疗 (CBT)加强正在进行的药物治疗(NB/安慰剂)。 在第1阶段随机对照试验中，N=160名有床位的肥胖患者将被随机分配(双盲)在 平衡析因(2×2)设计试验，四种为期16周的干预措施之一：BWL+NB、BWL+安慰剂、NB或 安慰剂。在第二阶段随机对照试验中，对第一阶段治疗(定义为狂欢减少65%或更多)的“响应者” 进食)将按相同比例随机进行(分层区组随机，阶段1治疗为 分层变量)，以NB或安慰剂(双盲)治疗16周。对第一阶段治疗没有反应的人将会 继续正在进行的药物治疗(NB/安慰剂；双盲)，50%随机接受CBT。 独立评估者将对暴饮暴食和肥胖以及他们的 通过12个月的随访期(即最初的随机化后的20个月)获得相关结果。 这项研究将产生关于BWL相对疗效的重要新信息 FDA批准的抗肥胖药物)，单独或联合用于肥胖症患者的床上治疗。这项研究将 产生新的和新的信息，关于在最初的急性治疗的应答者中， 与安慰剂相比，药物治疗的结果是更好的维持和更长期的结果。这项研究将产生 关于结果的预测者、调解者和中介者的重要发现 以经验为指导的处方和进一步的治疗改进。最后，这项研究将产生小说 关于在对最初的急性治疗无效的患者中，添加CBT是否会增强- 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.