Clinical Trial: Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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 .

Detailed Summary:
Sponsor: Lightlake Sinclair Ltd.

Current Primary Outcome: Change from baseline in frequency of binge eating [ Time Frame: 0 and 24 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Becks depression inventory (BDI) [ Time Frame: -1,0, 24 weeks ]
  • Analogic binge eating craving scale (BES-VAS) [ Time Frame: -1,0,24 weeks ]
  • Binge eating severity scale (BES) [ Time Frame: -1,0,24 weeks ]


Original Secondary Outcome: Same as current

Information By: Lightlake Sinclair Ltd.

Dates:
Date Received: March 13, 2012
Date Started: August 2011
Date Completion:
Last Updated: March 29, 2012
Last Verified: March 2012