Phase 3
N=3
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders
Binge-Eating Disorder · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03946111 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Change in Binge-Eating Frequency — -14; -17.00 episodes per past 28 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Naltrexone and Bupropion (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Binge-Eating Frequency |
4; 1.50 | — |
| PRIMARY Change in Binge-Eating Frequency |
4; 1.50 | — |
| PRIMARY Change in Binge-Eating Frequency |
4; 1.50 | — |
| PRIMARY Percent Change in Weight |
12.33; 3.32 | — |
| PRIMARY Percent Change in Weight |
12.33; 3.32 | — |
| PRIMARY Percent Change in Weight |
12.33; 3.32 | — |
| SECONDARY Binge-Eating Remission |
0; 1 | — |
| SECONDARY Binge-Eating Remission |
0; 1 | — |
| SECONDARY Binge-Eating Remission |
0; 1 | — |
| SECONDARY Change in Eating-Disorder Psychopathology (Continuous) |
0.76; -0.22 | — |
| SECONDARY Change in Eating-Disorder Psychopathology (Continuous) |
0.76; -0.22 | — |
| SECONDARY Change in Eating-Disorder Psychopathology (Continuous) |
0.76; -0.22 | — |
| SECONDARY Change in Depressive Symptoms |
-1.0; 2.50 | — |
| SECONDARY Change in Depressive Symptoms |
-1.0; 2.50 | — |
| SECONDARY Change in Depressive Symptoms |
-1.0; 2.50 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18 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
Exclusion Criteria
- 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
- History or current alcohol or substance use disorder (smoking is not exclusionary)
- 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
- Current use of medications contraindicated with the study medications
- Currently breast feeding or pregnant, or not willing to use reliable form of contraception
- Currently taking opioid pain medications or drugs
- Currently using effective treatment (evidence-based therapeutic or psychopharmacologic) for eating and/or weight loss
- Currently participating in another clinical study in which the participant is or will be exposed to an investigational or a non-investigational drug or device
- Medical status judged by study physician as contraindication
Data sourced from ClinicalTrials.gov (NCT03946111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.