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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01567670

Acronym

BED

Enrollment

138

Registered

2012-03-30

Start date

2011-08-31

Completion date

Unknown

Last updated

2012-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating Disorder

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 .

Interventions

DRUGNaloxone

2 mg x 1-2

DRUGnaloxone placebo

h2o placebo spray

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in frequency of binge eating	0 and 24 week

Secondary

Measure	Time frame
Becks depression inventory (BDI)	-1,0, 24 weeks
Analogic binge eating craving scale (BES-VAS)	-1,0,24 weeks
Binge eating severity scale (BES)	-1,0,24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026