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NB medication (Naltrexone Bupropion combination) for Binge Eating Disorder

Phase 2 & 3

Waitlist Available

Led By Carlos 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 post-treatment (4 months)

Awards & highlights

Study Summary

This trial will compare behavioral weight loss to weight loss plus medication, to see which is more effective for people with binge eating disorder and obesity.

Eligible Conditions

Binge Eating Disorder
Obesity

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

Binge Eating Frequency (Continuous)

Body Mass Index (Percent Weight Loss)

Secondary outcome measures

Number of Participants Meeting Response Criteria

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

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. 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: BWL + PlaceboExperimental Treatment2 Interventions

Participants randomly assigned to this arm will receive 16 weeks 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 16 weeks of Behavioral Weight Loss (BWL) counseling and 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 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 (BWL) counseling

2017

Completed Phase 3

~190

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

1,848 Previous Clinical Trials

2,737,682 Total Patients Enrolled

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

2,358 Previous Clinical Trials

4,314,938 Total Patients Enrolled

Carlos Grilo, PhDPrincipal InvestigatorYale School of Medicine

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

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

Out of how many people who express interest are being enrolled in this research project?

"Unfortunately, this study is no longer enrolling patients. The clinical trial was first posted on February 27th, 2017 and was last updated on July 7th, 2022. However, there are presently 1086 other clinical trials actively admitting participants with obesity and 71 studies for NB medication (Naltrexone Bupropion combination) actively searching for patients."

Answered by AI

Does this research extend to adult patients outside of the traditional age range?

"To be eligible for this clinical trial, patients must be between 18 and 70 years old."

Answered by AI

What is the standard prescription for NB medication?

"The most common treatment for ADHD is a NB medication cocktail (Naltrexone Bupropion combination). This medication is also effective for treating other disorders like seasonal affective disorder, smoking cessation, and smoke."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment

2017. "Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03045341.