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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
Lightlake Sinclair Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 13, 2012
    Last Updated
    March 29, 2012
    Sponsor
    Lightlake Sinclair Ltd.
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    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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