NCT03946111CompletedPhase 2/3
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders
Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 22 Apr 2019
- Start date
- 7 Aug 2019
- Primary completion date
- 5 Dec 2024
- Lead sponsor
- Yale University
- Diseases
- Obesity
- NCT number
- NCT03946111
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 3
- From 7 Aug 2019 to the primary completion date, 5 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Currently taking MAOI, SSRI or strong inhibitors of CYP2D6
- Current use of medications contraindicated with the study medications
- 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
Other illness
- 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
- 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
- History of allergy or sensitivity to the study medication or stimulant medications
Other
- Endorses current active suicidal or homicidal ideation with intent or plan
- Currently breast feeding or pregnant, or not willing to use reliable form of contraception
- Medical status judged by study physician as contraindication
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale Department of Psychiatry Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.