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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01567670
Recruitment Status : Unknown
Verified March 2012 by Lightlake Sinclair Ltd..
Recruitment status was:  Active, not recruiting
First Posted : March 30, 2012
Last Update Posted : March 30, 2012
Information provided by (Responsible Party):
Lightlake Sinclair Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2011
Estimated Primary Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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

Primary Outcome Measures :
  1. Change from baseline in frequency of binge eating [ Time Frame: 0 and 24 week ]

Secondary Outcome Measures :
  1. Becks depression inventory (BDI) [ Time Frame: -1,0, 24 weeks ]
  2. Analogic binge eating craving scale (BES-VAS) [ Time Frame: -1,0,24 weeks ]
  3. Binge eating severity scale (BES) [ Time Frame: -1,0,24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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Responsible Party: Lightlake Sinclair Ltd. Identifier: NCT01567670    
Other Study ID Numbers: 72925
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents