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

NCT ID: NCT04599504

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-02
• Study Completion Date: 2027-05-31

Brief Summary

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.

Conditions

Loss-of-control Eating; Obesity/Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lisdexamfetamine dimesylate

Group Type: EXPERIMENTAL

Lisdexamfetamine Dimesylate (Medication)

Intervention Type: DRUG

Medication will be taken daily in pill form.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will be inactive and taken daily in pill form.

Interventions

Lisdexamfetamine Dimesylate (Medication)

Medication will be taken daily in pill form.

Intervention Type: DRUG

Placebo

Placebo will be inactive and taken daily in pill form.

Intervention Type: OTHER

Other Intervention Names

Vyvanse

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Grilo, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

5R01DK126637-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000029057b

Identifier Type: -

Identifier Source: org_study_id