← Back to Search

Combination Drug

NB medication (Naltrexone Bupropion combination) for Obesity

Phase 2 & 3

Waitlist Available

Led By Carlos M Grilo, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month follow-up

Awards & highlights

Study Summary

This trial will compare the effectiveness of naltrexone/bupropion medication to placebo as a maintenance therapy for treating binge eating disorder in obese patients.

Eligible Conditions

Obesity
Binge Eating Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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.

Secondary outcome measures

Binge Eating Frequency (Continuous)

Change in Body Mass Index

Change in Body Mass Index (BMI)

Side effects data

From 2022 Phase 2 & 3 trial • 136 Patients • NCT03045341

59%

Dry Mouth

48%

Nausea

48%

Headache

44%

Dizziness

41%

Constipation

41%

Insomnia

11%

Anxiety

11%

Diarrhea

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

NB Medication

BWL + Placebo

BWL + NB Medication

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NB medicationExperimental Treatment1 Intervention

Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.

Group II: 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

NB medication (Naltrexone Bupropion combination)

2017

Completed Phase 3

~210

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,373 Total Patients Enrolled

59 Trials studying Obesity

248,080 Patients Enrolled for Obesity

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

2,359 Previous Clinical Trials

4,314,523 Total Patients Enrolled

446 Trials studying Obesity

588,870 Patients Enrolled for Obesity

Carlos M Grilo, PhDPrincipal InvestigatorYale School of Medicine

4 Previous Clinical Trials

390 Total Patients Enrolled

3 Trials studying Obesity

301 Patients Enrolled for Obesity

Frequently Asked Questions

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

For what reasons is the NB medication (Naltrexone Bupropion combination) most often given to patients?

"Naltrexone Bupropion (NB) medication is commonly used to treat attention deficit hyperactivity disorder (ADHD), but it can also be effective against seasonal affective disorder, smoking, and smoke cessation."

Answered by AI

What are the medical requirements for potential participants in this trial?

"The target population for this research are individuals between 18-70 years old that have been diagnosed with binge-eating disorder. There are several key inclusion criteria that potential participants must meet, which are: being able to commit to the 20 month treatment program, having received treatment for binge-eating disorder and obesity in the past, being able to travel to New Haven, Connecticut for monthly appointments, and having had a positive response to prior treatment."

Answered by AI

Is this study limited to a specific age group?

"This particular clinical trial requires that patients be aged 18 to 70. However, there are a total of 250 trials that cater to patients below the age of 18 and 716 that are for patients aged 65 and older."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

2017. "Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03047005.