Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray

NCT01567670 | Unknown Phase 2 DMC

• 1 other identifier: 72925
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (1)

• Change from baseline in frequency of binge eating

  0 and 24 week

Secondary Outcomes (3)

• 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

Study Arms (2)

Naloxone

ACTIVE COMPARATOR

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

Drug: Naloxone

nasal spray

PLACEBO COMPARATOR

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

Drug: naloxone placebo

Interventions

Naloxone DRUG

2 mg x 1-2

Naloxone

naloxone placebo DRUG

h2o placebo spray

nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Drug usage
• Retarded
• Severe mental illness

Sponsors & Collaborators

• Lightlake Sinclair Ltd.: lead

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 30, 2012
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Last Updated: March 30, 2012

Record last verified: 2012-03