跳至主要内容
临床试验/NCT01567670
NCT01567670Unknown2 期

Clinical Controlled Trial on Extinction of Opioidergic Binge Eating Disorder (BED) With Intranasal Naloxone Administration

Lightlake Sinclair Ltd.0 个研究点目标入组 138 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

nasal spray before binging, naloxone dose 2 mg, maximum daily dose 4 mg

干预措施: Naloxone (Drug)

nasal spray

Placebo Comparator

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)

研究者

发起方
Lightlake Sinclair Ltd.
申办方类型
Other
责任方
Sponsor

相似试验