Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Lightlake Sinclair Ltd.
ClinicalTrials.gov Identifier: NCT01567670     History of Changes
Other Study ID Numbers: 72925
Study First Received: March 13, 2012
Last Updated: March 29, 2012
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Disease
Eating Disorders
Hyperphagia
Mental Disorders
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Naloxone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014