Clinical trial NCT03539900: Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Official title: Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Binge-Eating Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-05-29
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.

Detailed description: Binge-eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.

Eligibility criteria: Inclusion Criteria:

* Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
* BMI in the obesity (BMI \>30 and \<50) or non-obesity (BMI \>21.5 and \<29.9) range;
* Available for the duration of the treatment and follow-up (15 months);
* Read, comprehend, and write English at a sufficient level to complete study-related materials.

Exclusion Criteria:

* Currently taking opioid pain medications or drugs; or positive drug screen for opiates
* Currently taking medications that influence eating/weight;
* History of seizures;
* Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
* Past or current anorexia nervosa or bulimia nervosa;
* Pregnant or breastfeeding;
* Medical status judged by study physician as contraindication.

Primary outcomes:
measure: Change in Binge Eating Frequency
timeFrame: Post-treatment (3 months)
measure: Percent BMI Change
timeFrame: Post-treatment (3 months)
Secondary outcomes:
measure: Change in Binge Eating Frequency
timeFrame: 6 months post-treatment
measure: Change in Binge Eating Frequency
timeFrame: 12 months post-treatment
measure: Body Mass Index
timeFrame: 6 months post-treatment
measure: Body Mass Index
timeFrame: 12 months post-treatment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Carlos M Grilo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Sherry McKee, PhD
role: PRINCIPAL_INVESTIGATOR
References: