Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Binge Eating Frequency (Continuous)
研究概览
简要总结
This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.
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 obese patients with BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (acute treatment stage) aims 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 patients with obesity. The acute treatment stage 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 patients with obesity and BED. N=160 patients with BED and obesity 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. 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 patients with obesity.
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
- Double (Participant, 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 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50;
- •Available for the duration of the treatment and follow-up (20 months);
- •Read, comprehend, and write English at a sufficient level to complete study-related materials;
- •Able to travel to study location (New Haven, CT) for weekly visits.
排除标准
- •Currently taking anti-depressant medications;
- •Currently taking opioid pain medications or drugs;
- •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, bulimia nervosa;
- •Pregnant or breastfeeding;
- •Medical status judged by study physician as contraindication.
研究组 & 干预措施
Placebo
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
干预措施: Placebo (Other)
BWL + NB medication
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
干预措施: NB medication (Naltrexone Bupropion combination) (Drug)
BWL + NB medication
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
干预措施: Behavioral Weight Loss (BWL) counseling (Behavioral)
BWL + Placebo
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
干预措施: Behavioral Weight Loss (BWL) counseling (Behavioral)
BWL + Placebo
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
干预措施: Placebo (Other)
NB medication
Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
干预措施: NB medication (Naltrexone Bupropion combination) (Drug)
结局指标
主要结局
Binge Eating Frequency (Continuous)
时间窗: Post-treatment (4 months)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Body Mass Index (Percent Weight Loss)
时间窗: Post-treatment (4 months)
BMI is calculated using measured height and weight. Percent weight loss, where negative values represent proportional weight loss, is calculated as the difference between weight at post-treatment and baseline weight, divided by baseline weight. By definition, all participants have 0% weight loss at baseline.
次要结局
- Number of Participants Meeting Response Criteria(Post-treatment (4 months))