Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders

NCT03946111 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2000022480_a1R01DK114075-01A1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the relative efficacy and effectiveness of the combination of naltrexone and bupropion (NB) medication as a treatment for binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, NB medication results in superior outcomes compared with placebo.

Conditions

Obesity; Binge-Eating Disorder

Outcome Measures

Primary Outcomes (6)

• Change in Binge-Eating Frequency

  Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.

  From baseline interview at study enrollment to 3 months after the 12-week treatment.

• Change in Binge-Eating Frequency

  Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.

  From post-treatment to the 6-month follow-up

• Change in Binge-Eating Frequency

  Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.

  From post-treatment to the 12-month follow-up

• Percent Change in Weight

  Negative values indicate weight loss and positive values indicate weight gain.

  From baseline interview at study enrollment to 3 months after the 12-week treatment.

• Percent Change in Weight

  Negative values indicate weight loss and positive values indicate weight gain.

  From post-treatment to the 6-month follow-up

• Percent Change in Weight

  Negative values indicate weight loss and positive values indicate weight gain.

  From post-treatment to the 12-month follow-up

Secondary Outcomes (9)

• Binge-Eating Remission

  12-weeks

• Binge-Eating Remission

  6-month follow-up

• Binge-Eating Remission

  12-month follow-up

• Change in Eating-Disorder Psychopathology (Continuous)

  From baseline interview at study enrollment to 3 months after the 12-week treatment.

• Change in Eating-Disorder Psychopathology (Continuous)

  From post-treatment to the 6-month follow-up

Study Arms (2)

Naltrexone/Bupropion

EXPERIMENTAL

Drug: Naltrexone and Bupropion

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Placebo OTHER

Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.

Placebo

Naltrexone and Bupropion DRUG

Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.

Naltrexone/Bupropion

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 64 years old
• Meets DSM-5 criteria for binge-eating disorder
• BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and \<50
• Medically cleared as determined by EKG and medical record review
• Available for the duration of the treatment and follow-up (18 months)
• Read, comprehend, and write English at a sufficient level to complete study-related materials
• Able to travel to study location (New Haven, CT) for weekly visits

You may not qualify if:

• Previous history of problems with LDX or other stimulants
• Current psychostimulant use or use of any medication for ADHD
• Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave
• History of congenital heart disease, known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, cerebrovascular pathology including stroke, exertional chest pain, uncontrolled high blood pressure, and other serious heart problems.
• History of severe renal, hepatic, neurological, or chronic pulmonary disease or other serious, unstable medical disorder.
• Current uncontrolled hypertension
• Current uncontrolled type I or II diabetes mellitus
• Current uncontrolled thyroid illness
• Gallbladder disease
• Co-occurring severe mental illness requiring hospitalization or intensive treatment
• Endorses current active suicidal or homicidal ideation with intent or plan
• Predisposition to seizures
• History of anorexia nervosa or bulimia nervosa, or currently regularly self-inducing vomiting
• Currently taking MAOI, SSRI or strong inhibitors of CYP2D6
• History of allergy or sensitivity to the study medication or stimulant medications

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale Department of Psychiatry

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder; Obesity

Interventions

bupropion hydrochloride, naltrexone hydrochoride drug combination

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Carlos M. Grilo
• Organization: Yale School of Medicine

carlos.grilo@yale.edu

2037857210

Study Officials

• Carlos M Grilo, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 10, 2019
• Study Start: August 7, 2019
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: January 9, 2026
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Locations

US (1)