Weight Regain Treatment Post-Bariatric Surgery

Phase 2

Completed

• Conditions: Obesity, Overweight
• Interventions: Behavioral: Behavioral Weight Loss (BWL)

• Registration Number: NCT04662801
• Lead Sponsor: Yale University

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Study Start: 2021-08-05
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-13
• Disposition First Submitted: 2023-09-05
• Disposition First Posted: 2023-09-29
• Status Verified: 2023-10
• Results First Submitted: 2023-10-19
• Results First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Results First Posted: 2023-11-13
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Behavioral Weight Loss + Medication	Behavioral Weight Loss (BWL)	-
Behavioral Weight Loss	Behavioral Weight Loss (BWL)	-

Primary Outcome Measures

Name	Time	Method
Body Mass Index	Post-treatment (3 months)	BMI is calculated using measured height and weight- kg/m2.

Secondary Outcome Measures

Name	Time	Method
Eating Disorder Psychopathology	Post-treatment (3 months)	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).
Depressive Symptoms	Post-treatment (3 months)	Depressive symptoms will be assessed by the Patient Health Questionnaire-9. The range is 0-27, which higher scores indicative of greater depressive symptomatology
Food Craving	Post-treatment (3 months)	Food craving will be assessed by the Food Craving Inventory (FCI). FCI scores range from 1-5, with higher scores indicative of greater craving.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States