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

• Sponsor: Lightlake Sinclair Ltd. (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01567670
• Collaborator: (none)
• Enrollment: 138
• Arms: 2

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Binge Eating Disorder	Drug: Naloxone; Drug: naloxone placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Controlled Trial on Extinction of Opioidergic Binge Eating Disorder (BED) With Intranasal Naloxone Administration
• Study Start Date: Aug 1, 2011
• Anticipated Primary Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Naloxone nasal spray before binging, naloxone dose 2 mg, maximum daily dose 4 mg	Drug: Naloxone; 2 mg x 1-2
Placebo Comparator: nasal spray nasal placebo (h2o) spray before binging, max sprays / day	Drug: naloxone placebo; h2o placebo spray

Outcome Measures

Primary Outcome Measures

1. Change from baseline in frequency of binge eating [0 and 24 week]

Secondary Outcome Measures

1. Becks depression inventory (BDI) [-1,0, 24 weeks]

2. Analogic binge eating craving scale (BES-VAS) [-1,0,24 weeks]

3. Binge eating severity scale (BES) [-1,0,24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Lightlake Sinclair Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lightlake Sinclair Ltd.
• ClinicalTrials.gov Identifier: NCT01567670
• Other Study ID Numbers: 72925
• First Posted: Mar 30, 2012
• Last Update Posted: Mar 30, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Naloxone

Study Results

No Results Posted as of Mar 30, 2012