3 Participants Needed

Naltrexone + Bupropion for Binge Eating Disorder and Obesity

VI
Overseen ByValentina Ivezaj, Ph.D.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

CM

Carlos M Grilo, Ph.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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
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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.
See 19 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Naltrexone/BupropionExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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

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Approved in United States as Cognitive Behavioral Therapy for:
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Approved in European Union as Cognitive Behavioural Therapy for:
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Approved in Canada as Cognitive Behavioral Therapy for:

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
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