Can vyvanse curb Post-Surgery binge eating? new trial aims to find out
NCT ID NCT04599504
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study tests whether the medication lisdexamfetamine (Vyvanse) can help people who experience loss-of-control eating after bariatric surgery and didn't improve with earlier treatments. About 60 adults who had gastric bypass or sleeve gastrectomy will receive either the drug or a placebo daily for several months. Researchers will track changes in eating episodes and body mass index to see if the medication offers real benefits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lisdexamfetamine (Vyvanse)
- What this could lead to
- If it works, this could offer a medication option to help people who struggle with loss-of-control eating after bariatric surgery, potentially improving their weight outcomes.
- What could go wrong
- This is a small, early-stage trial with only 60 participants, so results may not apply to everyone. The medication may cause side effects or not work better than a placebo.
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
-
16 people
The number who actually took part.
- Started
-
Jan 2022
- Finished
-
Jun 2026
- 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: * Be in the age range ≥18 years of age and \<65 years of age. * Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy * Approximately ten months post-surgery * Experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment non-responders to a four-month treatment trial of medication and/or BWL * Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies). * Read, comprehend, and write English at a sufficient level to complete study-related materials. * Provide a signed and dated written informed consent prior to study participation. * Be available for participation in the study for up to 15 months (3-month treatment plus 12-month follow up). Exclusion Criteria: * Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold). * Has a history of anorexia nervosa or history of bulimia nervosa. * Is currently using other medications for weight loss. * Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression) * Has untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute. * Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke. * Has current uncontrolled hypertension. * Has current uncontrolled Type I or Type II diabetes mellitus. * Has untreated hypothyroidism with a TSH \> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit. * Has gallbladder disease. * Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder. * Is currently in active treatment for eating or weight loss. * Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device. * Is breast-feeding or is pregnant or is not using a reliable form of birth control. * Reports active suicidal or homicidal ideation. * Previous history of problems with LDX or other stimulants. * Has a history of allergy or sensitivity to LDX or other stimulant medications. * Current medication contraindicated with study medication. * Any current psychostimulant use or any medication for ADHD. * History or current alcohol or substance use disorder (smoking will not be exclusionary) * Is currently taking MAOI medication, SSRI medication, or strong inhibitors of CYP2D6
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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
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Yale School of Medicine
New Haven, Connecticut, 06519, United States
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