Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

Yale University

Status: Completed

Conditions: Binge Eating Disorder

Treatments: Drug: Naltrexone and bupropion combination; Other: Pill Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02317744

1409014705

Details and patient eligibility

About

This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.

Enrollment: 22 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
• BMI between 30 kg/m2 and 50 kg/m2
• Not taking anti-depressant medications
• Read English proficiently enough to read study assessments
• Available for duration of treatment plus follow-up period
• Able to travel to study location (New Haven, CT) for monthly visits
• Agree to study procedures

Exclusion criteria

• Medical status judged by study physician as contraindication
• History of seizures
• Past or current anorexia nervosa, bulimia nervosa
• Current medications that influence eating/weight
• Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
• Pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

Naltrexone/ Bupropion combination

Experimental group

Description:

50 mg naltrexone and 300 mg bupropion per day for 3 months

Treatment:

Drug: Naltrexone and bupropion combination

Pill placebo

Placebo Comparator group

Description:

Daily placebo medication for 3 months

Treatment:

Other: Pill Placebo