Naltrexone + Bupropion for Binge Eating Disorder and Obesity

Overseen By Valentina Ivezaj, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Yale University

Must not be taking: Psychostimulants, MAOI, SSRI, Opioids

Disqualifiers: Heart disease, Severe mental illness, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

3 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test the relative efficacy and effectiveness of the combination of naltrexone and bupropion (NB) medication as a treatment for binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, NB medication results in superior outcomes compared with placebo.

Research Team

Carlos M Grilo, Ph.D.

Principal Investigator

Yale University

Eligibility Criteria

Adults aged 18-64 with binge-eating disorder and obesity (BMI between 27-50) can join this trial. They must understand English, be medically cleared via EKG, and able to visit New Haven, CT weekly for 18 months. Exclusions include heart disease, severe medical conditions, current use of certain medications like LDX or Bupropion, substance abuse disorders (except smoking), pregnancy without contraception use, other clinical study participation.

Inclusion Criteria

You have been diagnosed with binge-eating disorder according to the DSM-5 guidelines.

Available for the duration of the treatment and follow-up (18 months)

Read, comprehend, and write English at a sufficient level to complete study-related materials

Exclusion Criteria

I am currently taking Vyvanse, Wellbutrin, Zyban, Naltrexone, or Contrave.

My diabetes is not currently under control.

I am currently on a proven treatment plan for my eating or weight loss issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Naltrexone/Bupropion or placebo for binge-eating disorder and obesity

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Cognitive-Behavioral Treatment
• Naltrexone and Bupropion
• Placebo

Trial Overview The trial is testing if a combination of naltrexone and bupropion helps people who didn't respond to initial treatments for binge-eating disorder and obesity better than a placebo. Participants will either receive the medication combo or a placebo in controlled conditions.

Participant Groups

Group I: Naltrexone/Bupropion Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Cognitive-Behavioral Treatment is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Temporomandibular Disorders (TMD)
• Chronic Pain Management
• Depression

Approved in European Union as Cognitive Behavioural Therapy for:

• Temporomandibular Disorders (TMD)
• Chronic Pain Management
• Mental Health Conditions

Approved in Canada as Cognitive Behavioral Therapy for:

• Temporomandibular Disorders (TMD)
• Chronic Pain Management
• Anxiety Disorders

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+