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NB Medication for Weight Management After Bariatric Surgery

Phase 2 & 3
Waitlist Available
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
Be in the age range ≥18 years of age and ≤70 years of age.
Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
Must not have
Is currently taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates).
Is currently using other medications for weight loss.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from post-treatment to the 12-month follow-up

Summary

This trial will test whether naltrexone/bupropion can help people who have bariatric surgery to maintain weight loss and control their eating.

Who is the study for?
This trial is for adults aged 18-70 who've had bariatric surgery, are experiencing loss-of-control eating post-surgery, and responded to initial treatment. Participants must be healthy with controlled medical conditions and not using drugs or heavy alcohol. Pregnant women, those with certain heart diseases, uncontrolled diabetes or hypertension, seizure risks, severe psychiatric disorders, or allergies to the study medications cannot join.
What is being tested?
The study tests if Naltrexone/Bupropion (NB) medication helps maintain weight loss and control overeating after bariatric surgery better than a placebo. It's for those who initially responded well to treatments and will compare long-term outcomes between the NB medication group and the placebo group over a period of up to 15 months.
What are the potential side effects?
Possible side effects of Naltrexone/Bupropion may include nausea, headaches, constipation, dizziness, insomnia, dry mouth. There can also be more serious risks like seizures or elevated blood pressure in some individuals.

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 have had weight loss surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on medications like MAOIs or opiates that conflict with NB medication.
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I am currently taking medication to lose weight.
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My blood pressure or heart rate is higher than normal and untreated.
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I have a history of heart or blood vessel diseases, including stroke.
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My high blood pressure is not under control.
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My diabetes is not currently under control.
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I have gallbladder disease.
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I have a severe kidney, liver, nerve, lung disease, or another serious health issue.
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I am currently receiving treatment for an eating disorder or to lose weight.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Mass Index (BMI)
Loss-of-control eating Relapse
Secondary study objectives
Depressive Symptoms
Eating Disorder Psychopathology
Loss-of-control eating Frequency

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Naltrexone+Bupropion MedicationExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,582 Total Patients Enrolled
2 Trials studying Obesity/Overweight
220 Patients Enrolled for Obesity/Overweight
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,732 Total Patients Enrolled
3 Trials studying Obesity/Overweight
588 Patients Enrolled for Obesity/Overweight
Valentina Ivezaj, Ph.D.Principal InvestigatorYale University
2 Previous Clinical Trials
193 Total Patients Enrolled

Media Library

Naltrexone and Bupropion (NB) medication (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04605081 — Phase 2 & 3
Obesity/Overweight Research Study Groups: Naltrexone+Bupropion Medication, Placebo
Obesity/Overweight Clinical Trial 2023: Naltrexone and Bupropion (NB) medication Highlights & Side Effects. Trial Name: NCT04605081 — Phase 2 & 3
Naltrexone and Bupropion (NB) medication (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04605081 — Phase 2 & 3
~33 spots leftby May 2026
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