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Medication + Behavioral Therapy for Post-Bariatric Surgery Weight Control

Phase 2 & 3

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be in the age range ≥18 years of age and ≤70 years of age

Be in the age range ≥18 years of age and ≤70 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment (4 months)

Awards & highlights

Study Summary

This trial will compare the effectiveness of different treatments for loss-of-control eating and weight following bariatric surgery.

Who is the study for?

Adults aged 18-70 who've had bariatric surgery (gastric bypass or sleeve gastrectomy) about six months ago, with a BMI of 30-50 (or ≥27 if they have certain health issues), experiencing weekly loss-of-control eating. They must be generally healthy, not on weight loss or contraindicated meds, and able to commit to up to 19 months in the study.Check my eligibility

What is being tested?

The trial is testing how well behavioral weight loss strategies work compared to or combined with Naltrexone/Bupropion medication for controlling eating and managing weight after bariatric surgery. Participants will either receive the drug combo, placebo, or just behavioral therapy.See study design

What are the potential side effects?

Naltrexone/Bupropion can cause nausea, headaches, constipation, dizziness, insomnia and dry mouth. There's also a risk for more serious effects like high blood pressure and seizures especially in those predisposed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I am between 18 and 70 years old.

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I have had weight loss surgery.

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My BMI is between 27 and 50, and I may have a health condition if it's under 30.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment (4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment (4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment (4 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Mass Index

Loss-of-control Eating Frequency

Secondary outcome measures

Depressive Symptoms

Eating Disorder Psychopathology

Loss-of-control Eating Remission

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: NB medicationExperimental Treatment1 Intervention

Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.

Group II: Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medicationExperimental Treatment2 Interventions

Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.

Group III: BWL + PlaceboExperimental Treatment2 Interventions

Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.

Group IV: PlaceboPlacebo Group1 Intervention

Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Weight Loss

2011

N/A

~320

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,053 Total Patients Enrolled

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

2,359 Previous Clinical Trials

4,315,335 Total Patients Enrolled

Media Library

Behavioral Weight Loss Clinical Trial Eligibility Overview. Trial Name: NCT04599478 — Phase 2 & 3

Binge Eating Disorder Research Study Groups: BWL + Placebo, Placebo, NB medication, Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication

Binge Eating Disorder Clinical Trial 2023: Behavioral Weight Loss Highlights & Side Effects. Trial Name: NCT04599478 — Phase 2 & 3

Behavioral Weight Loss 2023 Treatment Timeline for Medical Study. Trial Name: NCT04599478 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some reasons why people might want to seek out Behavioral Weight Loss?

"Although it is commonly used to treat attention deficit hyperactivity disorder, Behavioral Weight loss can also be an effective intervention for seasonal affective disorder, smoking cessation, and smoke."

Answered by AI

Are new participants still being recruited for this research project?

"According to information available on clinicaltrials.gov, this study is open for enrollment and actively recruiting participants. The trial was originally posted on June 29th, 2021 with the most recent edit having been made on October 4th, 2022."

Answered by AI

Does this research only seek out elderly participants?

"The age range for individuals eligible to participate in this clinical trial is 18-70 years old."

Answered by AI

How many individuals can be enrolled in this clinical trial at one time?

"The information available on clinicaltrials.gov verifies that this study is still enrolling patients. This trial was first posted on 6/29/2021, and the most recent update was made on 10/4/2022. Furthermore, only 1 location is recruiting 160 patients for the study."

Answered by AI

What are the goals that this experiment is looking to achieve?

"The purpose of this clinical trial, which will span a period of 4 months post-treatment, is to monitor changes in Body Mass Index. Additionally, the researchers hope to gain insights into secondary objectives like 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).), Loss-of-control Eating Remission (Categorical: zero episodes/28 days), and Weight loss ("

Answered by AI