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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Lightlake Sinclair Ltd..
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: March 30, 2012
Last Update Posted: March 30, 2012
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.
Information provided by (Responsible Party):
Lightlake Sinclair Ltd.
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 Intervention Phase
Binge Eating Disorder Drug: Naloxone Drug: naloxone placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Lightlake Sinclair Ltd.:

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

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

Estimated Enrollment: 138
Study Start Date: August 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
No Contacts or Locations Provided
  More Information

Responsible Party: Lightlake Sinclair Ltd.
ClinicalTrials.gov Identifier: NCT01567670     History of Changes
Other Study ID Numbers: 72925
First Submitted: March 13, 2012
First Posted: March 30, 2012
Last Update Posted: March 30, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Feeding and Eating Disorders
Binge-Eating Disorder
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents