Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)

Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)

This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following bariatric surgery. This is a controlled test of whether, amongst non-responders to acute treatments, lisdexamfetamine medication results in superior outcomes compared with placebo.

Study Overview

• Status: Completed
• Conditions: Loss-of-control Eating; Obesity/Overweight
• Intervention / Treatment: Drug: Lisdexamfetamine Dimesylate (Medication); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo will be inactive and taken daily in pill form.
Experimental: Lisdexamfetamine dimesylate	Drug: Lisdexamfetamine Dimesylate (Medication); Medication will be taken daily in pill form.; Other Names: Vyvanse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loss-of-Control Eating Frequency	Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.	At the end of 12-week treatment
Loss-of-Control Eating Frequency	Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.	6-month follow-up from the end of treatment
Loss-of-Control Eating Frequency	Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.	12-month follow-up from the end of treatment
Percent Weight Change	Percent weight loss is calculated based on change from pre-treatment to post-treatment at 3 months. Negative values indicate weight loss.	From baseline at study enrollment to after the 12-week treatment
Percent Weight Change	Percent weight loss is calculated based on change from post-treatment to the 6-month follow-up. Negative values indicate weight loss.	From post-treatment to the 6-month follow-up
Percent Weight Change	Percent weight loss is calculated based on change from post-treatment to the 12-month follow-up. Negative values indicate weight loss.	From post-treatment to the 12-month follow-up

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Carlos Grilo, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Actual): June 4, 2026
• Study Completion (Actual): June 4, 2026

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Organic Chemicals; Pharmaceutical Preparations; Investigative Techniques; Amines; Technology, Pharmaceutical; Phenethylamines; Ethylamines; Amphetamines; Dextroamphetamine; Amphetamine; Lisdexamfetamine Dimesylate; Dosage Forms
• Other Study ID Numbers: 2000029057b; 5R01DK126637-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No