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Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray

NCT ID: NCT01567670

Last Updated: 2012-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Brief Summary

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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

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Conditions

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Binge Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Naloxone

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

Group Type ACTIVE_COMPARATOR

Naloxone

Intervention Type DRUG

2 mg x 1-2

nasal spray

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

Group Type PLACEBO_COMPARATOR

naloxone placebo

Intervention Type DRUG

h2o placebo spray

Interventions

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Naloxone

2 mg x 1-2

Intervention Type DRUG

naloxone placebo

h2o placebo spray

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lightlake Sinclair Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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72925

Identifier Type: -

Identifier Source: org_study_id