Cognitive-Behavioral and Pharmacologic Treatment of Binge Eating Disorder

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对卧床和肥胖患者的治疗， 产生持续的临床结果。 本研究旨在进行一项两阶段随机对照试验（RCT），比较 两种领先但不同的治疗方法-利右苯丙胺（LDX）和认知行为疗法（CBT）-单独 结合起来，对于床。LDX是FDA批准的唯一一种用于BED的药物，已证明其具有短期 相对于安慰剂的有效性，但与其他活性治疗的有效性相当， 结果未知。第一阶段随机对照试验将提供关于以下方面的相对有效性的新发现： LDX、CBT和CBT+LDX联合治疗BED肥胖患者。第二阶段RCT将提供新的 对照试验的结果，在接受急性药物治疗的第1阶段患者中， LDX（即，LDX或CBT+LDX）并显示阳性临床反应，继续LDX用药导致 与安慰剂相比，维持治疗和长期结局具有上级优势。第二阶段RCT还将提供新的 关于第1阶段药物治疗的无应答者中， 药物（纳洛酮-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BED药物治疗的长期结果的研究， 与BED的公共卫生意义的差异，包括记录的患病率，与 肥胖和生物心理社会发病率升高。 在第1阶段RCT中，N=180例BED肥胖患者将被随机分配至3个12周 干预：CBT，LDX或CBT+LDX。在第2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%或以上）将被随机分配到相同的 LDX或安慰剂的比例（分层区组随机化，首次治疗作为分层变量） （双盲）12周。急性药物治疗的“无应答者”将被随机分配至第二组， 药物治疗（纳洛酮-安非他酮或安慰剂;双盲）12周。接受CBT的第1阶段患者将 不需要进一步的干预治疗。独立的结果评估将确定相对 急性有效性、药物维持有效性和18个月的长期维持。 第二个目标是提供关于结果预测因素和调节因素的重要新数据。 治疗效果以告知处方（即，LDX和CBT工作最好的人），调解人的探索 通过这两种不同的方法的工作，探索交替药物治疗初始非- 响应者，并产生成本效益估计。 这项研究将产生关于床和肥胖症的“适应性”SMART治疗方法的新发现。

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.