Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray

Binge Eating Disorder Clinical Trial

— BED  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01567670
• Other study ID #: 72925
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: March 13, 2012
• Last updated: March 29, 2012
• Start date: August 2011

Study information

• Verified date: March 2012
• Source: Lightlake Sinclair Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders

Intervention

Drug:
• Naloxone
2 mg x 1-2
• naloxone placebo
h2o placebo spray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lightlake Sinclair Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in frequency of binge eating		0 and 24 week	No
Secondary	Becks depression inventory (BDI)		-1,0, 24 weeks	No
Secondary	Analogic binge eating craving scale (BES-VAS)		-1,0,24 weeks	No
Secondary	Binge eating severity scale (BES)		-1,0,24 weeks	No