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

March 29, 2012 updated by: Lightlake Sinclair Ltd.

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in frequency of binge eating
Time Frame: 0 and 24 week
0 and 24 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Becks depression inventory (BDI)
Time Frame: -1,0, 24 weeks
-1,0, 24 weeks
Analogic binge eating craving scale (BES-VAS)
Time Frame: -1,0,24 weeks
-1,0,24 weeks
Binge eating severity scale (BES)
Time Frame: -1,0,24 weeks
-1,0,24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lightlake Sinclair Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 29, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72925

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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