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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from post-treatment to the 12-month follow-up
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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It has been about 10 months since my surgery.
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I started losing control over eating 6 months post-bariatric surgery and responded well to a 4-month treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Mass Index (BMI)
Loss-of-control eating Relapse
Secondary outcome measures
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
1,837 Previous Clinical Trials
2,728,313 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
2,338 Previous Clinical Trials
4,314,099 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

Frequently Asked Questions

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

Are people with the required medical conditions able to join this trial at this time?

"This particular trial is not currently enrolling new participants, as it was last updated on October 4th, 2022. You may be interested in other trials concerning overweight individuals or those taking Naltrexone and Bupropion (NB) medication, of which there are presently 346 and 71 clinical trials respectively."

Answered by AI

Are there specific types of people who would be more likely to benefit from this trial?

"To qualify for this research, applicants must be overweight and between 18-70 years old. Up to one hundred individuals will be accepted into the trial."

Answered by AI

Is this clinical trial open to people who are under 40 years old?

"The age requirements for this study state that all participants must be over 18 and cannot be older than 70."

Answered by AI

What are the usual medical conditions that Naltrexone and Bupropion (NB) are employed to help alleviate?

"The NB medication, which is a combination of naltrexone and bupropion, can be used to treat conditions like attention deficit hyperactivity disorder (ADHD), seasonal affective disorder, and smoking cessation."

Answered by AI

How many test subjects are included in this experiment?

"As of right now, this clinical trial is not trying to recruit patients. The study was first posted on January 10th, 2022 and was edited October 4th, 2022. If you are looking for other studies, there are currently 346 trials actively enrolling patients with overweight and 71 trials for Naltrexone and Bupropion (NB) medication that need participants."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
Illinois
How old are they?
18 - 65
What site did they apply to?
Yale School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Yale School of Medicine: < 48 hours
Average response time
  • < 2 Days
~49 spots leftby May 2026