Weight Regain Treatment Post-Bariatric Surgery

A Behavioral Treatment With Sequenced Adjunctive Pharmacotherapy for Weight Regain After Bariatric Surgery: A Pilot Study

This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.

Study Overview

• Status: Completed
• Conditions: Obesity, Overweight
• Intervention / Treatment: Behavioral: Behavioral Weight Loss (BWL); Behavioral: Early Responder: BWL continued; Combination product: Early Non-responder: BWL continued with medication added

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be in the age range ≥18 years of age and ≤70 years of age
• Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and ≤50 kg/m2
• Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
• Experiencing weight regain after bariatric surgery
• 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 3 months.

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 taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates).
• Is currently using other medications for weight loss.
• Has a history of allergy or sensitivity to bupropion or naltrexone.
• 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.
• Has a recent history of drug or alcohol dependence (since having bariatric surgery).
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Weight Loss	Behavioral: Behavioral Weight Loss (BWL); All participants will receive twelve weeks of BWL treatment.; Behavioral: Early Responder: BWL continued; Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
Experimental: Behavioral Weight Loss + Medication	Behavioral: Behavioral Weight Loss (BWL); All participants will receive twelve weeks of BWL treatment.; Combination product: Early Non-responder: BWL continued with medication added; Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	BMI is calculated using measured height and weight- kg/m2.	Post-treatment (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Disorder Psychopathology	Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).	Post-treatment (3 months)
Depressive Symptoms	Depressive symptoms will be assessed by the Patient Health Questionnaire-9. The range is 0-27, which higher scores indicative of greater depressive symptomatology	Post-treatment (3 months)
Food Craving	Food craving will be assessed by the Food Craving Inventory (FCI). FCI scores range from 1-5, with higher scores indicative of greater craving.	Post-treatment (3 months)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: American Psychological Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 2000029491

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