This trial is active, not recruiting.

Condition binge eating disorder
Treatments naloxone, naloxone placebo
Phase phase 2/phase 3
Sponsor Lightlake Sinclair Ltd.
Start date August 2011
End date June 2012
Trial size 138 participants
Trial identifier NCT01567670, 72925


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 .

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
nasal spray before binging, naloxone dose 2 mg, maximum daily dose 4 mg
2 mg x 1-2
(Placebo Comparator)
nasal placebo (h2o) spray before binging, max sprays / day
naloxone placebo
h2o placebo spray

Primary Outcomes

Change from baseline in frequency of binge eating
time frame: 0 and 24 week

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Clinical Controlled Trial on Extinction of Opioidergic Binge Eating Disorder (BED) With Intranasal Naloxone Administration
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Lightlake Sinclair Ltd..