Overview

This trial is active, not recruiting.

Condition binge eating disorder
Treatments naltrexone and bupropion combination, pill placebo
Sponsor Yale University
Start date December 2014
End date September 2016
Trial size 22 participants
Trial identifier NCT02317744, 1409014705

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
50 mg naltrexone and 300 mg bupropion per day for 3 months
naltrexone and bupropion combination
(Placebo Comparator)
Daily placebo medication for 3 months
pill placebo

Primary Outcomes

Measure
Binge Eating Frequency (Categorical)
time frame: Post-treatment (at 3 months)
Binge Eating Frequency (Categorical)
time frame: 6 month follow-up (an average of 6 months following treatment)
Binge Eating Frequency (Continuous)
time frame: Post-treatment (at 3 months)
Binge Eating Frequency (Continuous)
time frame: 6 month follow-up (an average of 6 months following treatment)

Secondary Outcomes

Measure
Body Mass Index (BMI)
time frame: Post-treatment (at 3 months)
Body Mass Index (BMI)
time frame: 6 month follow-up (an average of 6 months following treatment)

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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

Additional Information

Official title Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo
Principal investigator Carlos M Grilo, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Yale University.