Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Percent BMI Change
研究概览
简要总结
This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.
详细描述
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 are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
- •BMI in the obesity (BMI >30 and <50) or non-obesity (BMI >21.5 and <29.9) range;
- •Available for the duration of the treatment and follow-up (15 months);
- •Read, comprehend, and write English at a sufficient level to complete study-related materials.
排除标准
- •Currently taking opioid pain medications or drugs; or positive drug screen for opiates
- •Currently taking medications that influence eating/weight;
- •History of seizures;
- •Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
- •Past or current anorexia nervosa or bulimia nervosa;
- •Pregnant or breastfeeding;
- •Medical status judged by study physician as contraindication.
研究组 & 干预措施
NB Medication
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
干预措施: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination (Drug)
Placebo
Placebo will be inactive and taken daily in pill form.
干预措施: Placebo (Other)
结局指标
主要结局
Percent BMI Change
时间窗: Post-treatment (3 months)
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at posttreatment\] - \[BMI at baseline\])/\[BMI at baseline\]. Negative values indicate loss.
Change in Binge Eating Frequency
时间窗: Post-treatment (3 months)
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."
次要结局
- Body Mass Index(12 months post-treatment)
- Change in Binge Eating Frequency(12 months post-treatment)