Can a stimulant drug stop Binge-Eating relapse? new study tests LDX
NCT ID NCT03926052
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether the drug lisdexamfetamine (LDX) can help adults with binge-eating disorder and obesity avoid relapse. 61 participants who initially responded to treatment were randomly assigned to receive LDX or a placebo for 12 weeks. The main goal was to see if LDX reduced the number of binge-eating episodes compared to placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lisdexamfetamine (LDX)
- What this could lead to
- If it works, this could provide a medication option to help people with binge-eating disorder maintain control and avoid relapse after initial treatment.
- What could go wrong
- This is a small, completed Phase 3 trial with only 61 participants, so results may not apply to everyone. LDX is a stimulant and can have side effects like increased heart rate or risk of misuse.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
61 people
The number who actually took part.
- Started
-
Aug 2019
- Finished
-
Nov 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 Hide 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.
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
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