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

• ClinicalTrials.gov Identifier: NCT04599504
• Recruitment Status: Enrolling by invitation
• First Posted: October 22, 2020
• Last Update Posted: February 7, 2022
• Sponsor: Yale University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Loss-of-control Eating; Obesity/Overweight	Drug: Lisdexamfetamine Dimesylate (Medication); Other: Placebo	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)
• Actual Study Start Date: January 2, 2022
• Estimated Primary Completion Date: May 2026
• Estimated Study Completion Date: May 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Loss-of-Control Eating Frequency [ Time Frame: From baseline interview at study enrollment to after the 12-week treatment ]
   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.
2. Loss-of-Control Eating Frequency [ Time Frame: From post-treatment to the 6-month follow-up ]
   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.
3. Loss-of-Control Eating Frequency [ Time Frame: From post-treatment to the 12-month follow-up ]
   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.
4. Body Mass Index (BMI) [ Time Frame: From baseline at study enrollment to after the 12-week treatment ]
   BMI is calculated using measured height and weight
5. Body Mass Index (BMI) [ Time Frame: From post-treatment to the 6-month follow-up ]
   BMI is calculated using measured height and weight
6. Body Mass Index (BMI) [ Time Frame: From post-treatment to the 12-month follow-up ]
   BMI is calculated using measured height and weight

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Connecticut

Yale School of Medicine

New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

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

Investigators

• Principal Investigator: Carlos Grilo, PhD; Yale School of Medicine

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04599504
• Other Study ID Numbers: 2000029057b; 5R01DK126637-02 ( U.S. NIH Grant/Contract )
• First Posted: October 22, 2020
• Last Update Posted: February 7, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Overweight; Body Weight; Lisdexamfetamine Dimesylate; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents