CompletedPhase 2/3

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

United States3 participantsStarted 2019-08-07

Plain-language 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.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 disorde…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Binge-Eating Frequency

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

Change in Binge-Eating Frequency

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

Change in Binge-Eating Frequency

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

Percent Change in Weight

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

Percent Change in Weight

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

Percent Change in Weight

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

Trial details

NCT IDNCT03946111

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-05

Results submitted2025-09-22

View on ClinicalTrials.gov More Binge-Eating Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Binge-Eating Frequency

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

Change in Binge-Eating Frequency

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

Change in Binge-Eating Frequency

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

Percent Change in Weight

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

Percent Change in Weight

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

Percent Change in Weight

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