Clinical Controlled Trial on Extinction of Opioidergic Binge Eating Disorder (BED) With Intranasal Naloxone Administration
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 138
- 主要终点
- Change from baseline in frequency of binge eating
研究概览
简要总结
The investigators are studying a new treatment for one subtype of obesity. Obesity is not a disease. It is a symptom of several different diseases. These diseases have distinct etiologies, being caused by aberrations in different mechanisms. Forms of obesity caused by such non-critical mechanisms might be corrected fairly easily and safely. The investigators are interested in overeating and obesity that is caused by the opioidergic system. The opioidergic system appears to be responsible for a subtype of obesity associated with binge eating disorder (BED). People, especially with the right genetic predisposition, can become addicted to foods that release endorphins, in the way that people become addicted to exogenous opiates and other drugs that release endorphins. The particular application in our proposed clinical trial is for intranasal (IN) naloxone. The peak levels of naloxone were similar and the bioavailability of naloxone intranasally was 100% (the same) of that available IV." IN administration of naloxone has since been broadly tested in humans, as well, where it has been shown to be safe, with pharmacokinetics similar to those of naloxone given by injection .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Binge eating disorder (DSM-IV) and body mass index (BMI) > 25
- •Binge eating screen > 20
排除标准
- •Pregnancy
- •Drug usage
- •Severe mental illness
研究组 & 干预措施
Naloxone
nasal spray before binging, naloxone dose 2 mg, maximum daily dose 4 mg
干预措施: Naloxone (Drug)
nasal spray
nasal placebo (h2o) spray before binging, max sprays / day
干预措施: naloxone placebo (Drug)
结局指标
主要结局
Change from baseline in frequency of binge eating
时间窗: 0 and 24 week
次要结局
- Becks depression inventory (BDI)(-1,0, 24 weeks)
- Analogic binge eating craving scale (BES-VAS)(-1,0,24 weeks)
- Binge eating severity scale (BES)(-1,0,24 weeks)
