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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Lightlake Sinclair Ltd.

Tracking Information
First Submitted Date  ICMJE March 13, 2012
First Posted Date  ICMJE March 30, 2012
Last Update Posted Date March 30, 2012
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
Change from baseline in frequency of binge eating [ Time Frame: 0 and 24 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray
Official Title  ICMJE Clinical Controlled Trial on Extinction of Opioidergic Binge Eating Disorder (BED) With Intranasal Naloxone Administration
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 .
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Binge Eating Disorder
Intervention  ICMJE
  • Drug: Naloxone
    2 mg x 1-2
  • Drug: naloxone placebo
    h2o placebo spray
Study Arms  ICMJE
  • Active Comparator: Naloxone
    nasal spray before binging, naloxone dose 2 mg, maximum daily dose 4 mg
    Intervention: Drug: Naloxone
  • Placebo Comparator: nasal spray
    nasal placebo (h2o) spray before binging, max sprays / day
    Intervention: Drug: naloxone placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 29, 2012)
138
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01567670
Other Study ID Numbers  ICMJE 72925
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lightlake Sinclair Ltd.
Study Sponsor  ICMJE Lightlake Sinclair Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lightlake Sinclair Ltd.
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP