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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Lightlake Sinclair Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Lightlake Sinclair Ltd.
ClinicalTrials.gov Identifier:
NCT01567670
First received: March 13, 2012
Last updated: March 29, 2012
Last verified: March 2012

March 13, 2012
March 29, 2012
August 2011
June 2012   (final data collection date for primary outcome measure)
Change from baseline in frequency of binge eating [ Time Frame: 0 and 24 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01567670 on ClinicalTrials.gov Archive Site
  • Becks depression inventory (BDI) [ Time Frame: -1,0, 24 weeks ] [ Designated as safety issue: No ]
  • Analogic binge eating craving scale (BES-VAS) [ Time Frame: -1,0,24 weeks ] [ Designated as safety issue: No ]
  • Binge eating severity scale (BES) [ Time Frame: -1,0,24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray
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 .

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Binge Eating Disorder
  • Drug: Naloxone
    2 mg x 1-2
  • Drug: naloxone placebo
    h2o placebo spray
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
138
Not Provided
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01567670
72925
Yes
Lightlake Sinclair Ltd.
Lightlake Sinclair Ltd.
Not Provided
Not Provided
Lightlake Sinclair Ltd.
March 2012

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