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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naloxone | Active Comparator | nasal spray before binging, naloxone dose 2 mg, maximum daily dose 4 mg |
|
| nasal spray | Placebo Comparator | nasal placebo (h2o) spray before binging, max sprays / day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxone | Drug | 2 mg x 1-2 |
| |
| naloxone placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in frequency of binge eating | 0 and 24 week |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Drug |
h2o placebo spray |
|
| -1,0,24 weeks |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |