Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray (BED)

Lightlake Sinclair

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Binge Eating Disorder

Treatments: Drug: naloxone placebo; Drug: Naloxone

Study type: Interventional

Funder types: Other

Identifiers

NCT01567670

72925

Details and patient eligibility

About

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 .

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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138 participants in 2 patient groups, including a placebo group

Naloxone

Active Comparator group

Description:

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

Treatment:

Drug: Naloxone

nasal spray

Placebo Comparator group

Description:

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

Treatment:

Drug: naloxone placebo