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Naltrexone + Bupropion for Binge Eating Disorder and Obesity

Phase 2 & 3
Waitlist Available
Led By Carlos M Grilo, 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
Medically cleared as determined by EKG and medical record review
BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50
Must not have
Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave
Current uncontrolled type I or II diabetes mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from post-treatment to the 12-month follow-up

Summary

This trial will compare the effectiveness of a combination of naltrexone and bupropion medication to placebo in patients with obesity who have not responded to other treatments for binge-eating disorder.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from naltrexone/bupropion may include nausea, headaches, constipation, dizziness, insomnia and dry mouth. There's also a risk for more serious issues like seizures or elevated blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart health is cleared by an EKG and doctor's review.
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My BMI is between 27-30 with a health issue related to obesity, or it's between 30 and under 50.
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I am between 18 and 64 years old.
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I can travel to New Haven, CT for weekly visits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking Vyvanse, Wellbutrin, Zyban, Naltrexone, or Contrave.
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My diabetes is not currently under control.
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I have gallbladder disease.
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My high blood pressure is not under control.
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I am not pregnant, breastfeeding, and I agree to use contraception.
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I am currently using medication for ADHD or psychostimulants.
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I am prone to having seizures.
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I do not have severe kidney, liver, nerve, lung diseases or other serious health issues.
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I have a history of serious heart conditions or high blood pressure.
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I am currently taking medication for depression or strong inhibitors for CYP2D6.
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My thyroid condition is not under control.
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I have had issues with LDX or similar medications before.
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I am not taking any medications that would interfere with the study drugs.
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I am currently taking opioid pain medications.
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I am allergic to the study medication or similar stimulants.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Binge-Eating Frequency
Body Mass Index
Secondary study objectives
Binge-Eating Remission
Depressive Symptoms
Eating-Disorder Psychopathology (Continuous)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Naltrexone/BupropionExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,450 Total Patients Enrolled
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,471 Total Patients Enrolled
Carlos M Grilo, Ph.D.Principal InvestigatorYale School of Medicine
4 Previous Clinical Trials
383 Total Patients Enrolled

Media Library

Cognitive-Behavioral Treatment (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03946111 — Phase 2 & 3
Binge Eating Disorder Research Study Groups: Placebo, Naltrexone/Bupropion
Binge Eating Disorder Clinical Trial 2023: Cognitive-Behavioral Treatment Highlights & Side Effects. Trial Name: NCT03946111 — Phase 2 & 3
Cognitive-Behavioral Treatment (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03946111 — Phase 2 & 3
~0 spots leftby Dec 2024
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