Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray

Phase 2

• Conditions: Binge Eating Disorder
• Interventions: Drug: Naloxone; Drug: naloxone placebo

• Registration Number: NCT01567670
• Lead Sponsor: Lightlake Sinclair Ltd.

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 Description

Not available

Study Timeline

• Study Start: 2011-08
• Status Verified: 2012-03
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-29
• Last Update Submitted: 2012-03-29
• Study First Posted: 2012-03-30
• Last Update Posted: 2012-03-30
• Primary Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

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

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Exclusion Criteria

• Pregnancy
• Drug usage
• Retarded
• Severe mental illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Naloxone	Naloxone	nasal spray before binging, naloxone dose 2 mg, maximum daily dose 4 mg
nasal spray	naloxone placebo	nasal placebo (h2o) spray before binging, max sprays / day

Primary Outcome Measures

Name	Time	Method
Change from baseline in frequency of binge eating	0 and 24 week

Secondary Outcome Measures

Name	Time	Method
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