Trial | NCT01567670  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    naloxone ...

  • Study Participants

    138
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 .
Study Started
Aug 31
2011
Primary Completion
Jun 30
2012
Anticipated
Last Update
Mar 30
2012
Estimate

Drug Naloxone

2 mg x 1-2

Drug naloxone placebo

h2o placebo spray

Naloxone Active Comparator

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

nasal spray Placebo Comparator

nasal placebo (h2o) spray before binging, max sprays / day

Criteria 

Inclusion Criteria:

Binge eating disorder (DSM-IV) and body mass index (BMI) > 25
Binge eating screen > 20

Exclusion Criteria:

Pregnancy
Drug usage
Retarded
Severe mental illness
No Results Posted