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Can a Two-Drug combo curb Binge-Eating and help weight loss?

NCT ID NCT03946111

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a combination of naltrexone and bupropion can reduce binge-eating episodes and promote weight loss in people with binge-eating disorder and obesity. Participants took either the drug combo or a placebo for 12 weeks. The trial was very small, with only 3 people enrolled, so results are preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naltrexone and bupropion combination
What this could lead to
If it works, this could offer a medication option to reduce binge-eating episodes and support weight loss in people with obesity.
What could go wrong
This is a very small, early-phase study with only 3 participants, so results may not apply broadly. The drug combo may cause side effects like nausea or insomnia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

3 people

The number who actually took part.

Started

Aug 2019

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

binge eating disorder Binge-Eating Disorder Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Yale Department of Psychiatry

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.