Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray (BED)
Primary Purpose
Binge Eating Disorder
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Naloxone
naloxone placebo
Sponsored by
About this trial
This is an interventional treatment trial for Binge Eating Disorder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Naloxone
nasal spray
Arm Description
nasal spray before binging, naloxone dose 2 mg, maximum daily dose 4 mg
nasal placebo (h2o) spray before binging, max sprays / day
Outcomes
Primary Outcome Measures
Change from baseline in frequency of binge eating
Secondary Outcome Measures
Becks depression inventory (BDI)
Analogic binge eating craving scale (BES-VAS)
Binge eating severity scale (BES)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01567670
Brief Title
Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray
Acronym
BED
Official Title
Clinical Controlled Trial on Extinction of Opioidergic Binge Eating Disorder (BED) With Intranasal Naloxone Administration
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lightlake Sinclair Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Naloxone
Arm Type
Active Comparator
Arm Description
nasal spray before binging, naloxone dose 2 mg, maximum daily dose 4 mg
Arm Title
nasal spray
Arm Type
Placebo Comparator
Arm Description
nasal placebo (h2o) spray before binging, max sprays / day
Intervention Type
Drug
Intervention Name(s)
Naloxone
Intervention Description
2 mg x 1-2
Intervention Type
Drug
Intervention Name(s)
naloxone placebo
Intervention Description
h2o placebo spray
Primary Outcome Measure Information:
Title
Change from baseline in frequency of binge eating
Time Frame
0 and 24 week
Secondary Outcome Measure Information:
Title
Becks depression inventory (BDI)
Time Frame
-1,0, 24 weeks
Title
Analogic binge eating craving scale (BES-VAS)
Time Frame
-1,0,24 weeks
Title
Binge eating severity scale (BES)
Time Frame
-1,0,24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray
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