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Pharmacological and Behavioral Treatment for Obesity After Bariatric Surgery

Phase 2 & 3
Recruiting
Led By Valentina Ivezaj, Ph.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
Must have suboptimal weight outcomes after MBS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from post-treatment (6-months) to the 12-month follow-up
Awards & highlights

Study Summary

This trial will compare how well two types of treatment, behavioral and pharmacologic, work when used alone or together to help people lose weight, improve cardiovascular risk factors, and function better socially after bariatric surgery.

Who is the study for?
This trial is for adults with obesity who've had bariatric surgery but haven't achieved desired weight loss. Participants must have a BMI between 27-50, be in good health, and willing to follow the study plan for up to 18 months. Women must use effective contraception; men should ensure contraception with partners.Check my eligibility
What is being tested?
The study tests if combining behavioral weight loss strategies with a medication (Naltrexone and Bupropion) is more effective than either approach alone or a placebo in improving post-surgery weight loss, cardiovascular health, and mental well-being.See study design
What are the potential side effects?
Possible side effects include nausea, constipation, headache, dry mouth from the medication combination of Naltrexone and Bupropion. Behavioral treatment generally has no side effects but requires commitment to lifestyle changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had weight loss surgery, either gastric bypass or sleeve gastrectomy.
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I haven't lost enough weight after my bariatric surgery.
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My BMI is between 30 and 50, or it's above 27 with a health condition.
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I am a man who can father children and will use contraception.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from post-treatment (6-months) to the 12-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and from post-treatment (6-months) to the 12-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Body Mass Index (BMI)
Secondary outcome measures
Change in Depressive Symptoms
Change in Eating Disorder Psychopathology
Change in Food Craving
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: NB medicationExperimental Treatment1 Intervention
Participants randomly assigned to this arm will receive 6 months of NB medication taken daily in pill form.
Group II: BWL + PlaceboExperimental Treatment2 Interventions
Participants randomly assigned to this arm will receive 6 months of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Group III: BWL + NB medicationExperimental Treatment2 Interventions
Participants randomly assigned to this arm will receive 6 months of Behavioral Weight Loss (BWL) counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
Group IV: PlaceboPlacebo Group1 Intervention
Participants randomly assigned to this arm will receive 6 months 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

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,508 Total Patients Enrolled
59 Trials studying Obesity
247,988 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,081 Total Patients Enrolled
446 Trials studying Obesity
588,778 Patients Enrolled for Obesity
Valentina Ivezaj, Ph.D.Principal InvestigatorYale School of Medicine
2 Previous Clinical Trials
133 Total Patients Enrolled

Media Library

Behavioral Weight Loss Clinical Trial Eligibility Overview. Trial Name: NCT05157698 — Phase 2 & 3
Obesity Research Study Groups: NB medication, BWL + Placebo, Placebo, BWL + NB medication
Obesity Clinical Trial 2023: Behavioral Weight Loss Highlights & Side Effects. Trial Name: NCT05157698 — Phase 2 & 3
Behavioral Weight Loss 2023 Treatment Timeline for Medical Study. Trial Name: NCT05157698 — 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 does Naltrexone and Bupropion Combination usually help patients with?

"Naltrexone and Bupropion Combination is used to commonly to treat attention deficit hyperactivity disorder (adhd) in patients. It can also be used to help those suffering from seasonal affective disorder, smoking, cessation, and smoke."

Answered by AI

Are researchers enrolling new participants for this trial at this time?

"The latest information available on clinicaltrials.gov suggests that this trial is still looking for participants. The posting went up on 1/13/2022 and was edited on 2/4/2022."

Answered by AI

What is the total number of individuals who can partake in this experiment?

"Yes, the data on clinicaltrials.gov says that this study is presently searching for participants. The clinical trial was originally posted on 1/13/2022 and was most recently updated on 2/4/2022. The study is enrolling 160 participants across 1 locations."

Answered by AI

Does this research include adolescents in the testing sample?

"In order to be eligible for this study, applicants must fall in between the ages of 18 to 70. Out of the 870 clinical trials currently underway, this is one of the 205 studies taking place for patients that are under 18 years old and one of the 665 for patients above the age of 65."

Answered by AI

If I take part in this clinical trial, will it benefit me?

"This upcoming clinical trial is set to test a new obesity treatment and is currently seeking 160 participants. To be eligible, patients must be between 18-70 years old, have a BMI of 30 or above (27 if there is a comorbidity), and have had a physical in the past year. Additionally, all patients must be willing to comply with the study procedures and be available for the duration of the study, which is 18 months. Finally, males of reproductive potential must use condoms or another form of contraception."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Yale School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pharmacological and Behavioral Treatment After Bariatric Surgery
2022. "Pharmacological and Behavioral Treatment After Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05157698.
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~87 spots leftby Jan 2027
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