Cognitive-Behavioral and Pharmacologic Treatment of Binge Eating Disorder

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。需要改进对卧床和肥胖患者的治疗，以便 产生可持续的临床结果。 本研究旨在进行两阶段随机对照试验(RCT)，以比较 两种领先但不同的治疗方法--左旋地塞非他明(LDX)和认知行为疗法(CBT)--单独使用 加在一起，睡在床上。LDX是FDA批准的唯一用于BED的药物，已显示出短期疗效 相对于安慰剂的有效性，但与其他积极治疗和更长期的有效性相比 结果还不得而知。第一阶段随机对照试验将提供关于以下各项相对有效性的新发现 LDX、CBT及CBT+LDX联合用药治疗肥胖卧床患者第二阶段RCT将提供新的 对照试验的结果，无论是在接受急性药物治疗的1期患者中 LDX(即LDX或CBT+LDX)的临床反应呈阳性，继续服用LDX的结果 比安慰剂更好的维护和更长期的结果。第二阶段RCT也将提供新的 关于在第一阶段药物治疗无反应者中是否改用替代药物的研究结果 药物治疗(纳曲酮-安非他酮；FDA批准用于肥胖)导致临床改善。本研究 解决了缺乏对床的药物治疗的长期结果的研究，这一点令人震惊 与床的公共健康意义的几率，包括有记录的流行率，与 肥胖和生物-心理-社会发病率的增加。 在第1阶段随机对照试验中，N=180名有床位的肥胖患者将被随机分配到3名12周的患者中 干预：CBT、LDX或CBT+LDX。在第二阶段，接受急性药物治疗(LDX或 Cbt+ldx)和“应答者”(暴饮暴食减少65%或更多)将被随机均分。 与LDX或安慰剂的比例(分层随机分组，首次治疗为分层变量) (双盲)治疗12周。对急性药物治疗无反应的人将被随机分配到第二个 用药(纳曲酮-安非他酮或安慰剂；双盲)12周。接受CBT的第一阶段患者将 在没有进一步干预治疗的情况下被跟踪。独立的结果评估将确定相对 急性疗效、药物维持效果和18个月的长期维持。 次要目标是提供重要的新数据，涉及结果的预测因素和 治疗效果告知处方(即，LDX和CBT对谁最有效)，探索调解人 通过这两种不同的方法发挥作用，探索最初非霍奇金淋巴瘤的交替药物治疗。 应急者，以及成本效益估算的生成。 这项研究将在床上和肥胖的“适应性”智能治疗方法方面产生新的发现。

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED and obesity are needed that can produce sustained clinical outcomes. This study aims to perform a two-stage randomized controlled trial (RCT) to compare the effectiveness of two leading but distinct treatments — lisdexamfetamine (LDX) and cognitive behavioral therapy (CBT) — alone and in combination, for BED. LDX is the only FDA-approved medication for BED, has demonstrated short-term effectiveness relative to placebo, but comparative effectiveness to other active treatments and longer-term outcomes are unknown. The first stage RCT will provide new findings regarding the relative effectiveness of LDX, CBT, and combined CBT+LDX for obese patients with BED. The second stage RCT will provide novel findings from a controlled test, whether amongst Stage 1 patients who received acute pharmacotherapy with LDX (i.e., LDX or CBT+LDX) and showed a positive clinical response, continued LDX medication results in superior maintenance and longer-term outcomes than placebo. The second Stage RCT will also provide novel findings regarding whether amongst non-responders to Stage 1 pharmacotherapy, switching to an alternative medication (Naltrexone-Bupropion; FDA-approved for obesity) results in clinical improvements. This study addresses the dearth of research on longer-term outcomes of pharmacotherapy for BED, which is strikingly at odds with the public health significance of BED, including documented prevalence, strong association with obesity, and heightened bio-psychosocial morbidity. In Stage 1 RCT, N=180 obese patients with BED will be randomly assigned to one of three 12-week interventions: CBT, LDX, or CBT+LDX. In Stage 2, patients who received acute pharmacotherapy (LDX or CBT+LDX) and were “responders” (65% or greater reduction in binge eating) will be randomized in equal proportions (stratified blocked randomization with first treatment as stratifying variable) to LDX or placebo (double-blind) for 12 weeks. “Non-responders” to acute pharmacotherapy will be randomized to a second medication (Naltrexone-Bupropion or placebo; double-blind) for 12 weeks. Stage 1 patients receiving CBT will be followed without further intervening treatment. Independent outcome assessments will determine relative acute effectiveness, medication maintenance effectiveness, and longer-term maintenance through 18 months. Secondary aims are to contribute important new data regarding predictors of outcomes and moderators of treatment effects to inform prescription (i.e., for whom the LDX and CBT work best), exploration of mediators through which these two distinct methods work, exploration of alternmative pharmacotherapy for initial non- responders, and generation of cost-effectiveness estimates. This study will produce novel findings regarding “adaptive” SMART treatment methods for BED and obesity.