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Naltrexone + Bupropion for Binge Eating Disorder and Obesity
Phase 2 & 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from post-treatment to the 12-month follow-up
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am between 18 and 64 years old.
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I can travel to New Haven, CT for weekly visits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from post-treatment to the 12-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from post-treatment to the 12-month follow-up
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
Body Mass Index
Secondary outcome measures
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
2,358 Previous Clinical Trials
4,315,201 Total Patients Enrolled
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,778 Total Patients Enrolled
Carlos M Grilo, Ph.D.Principal InvestigatorYale School of Medicine
4 Previous Clinical Trials
422 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking Vyvanse, Wellbutrin, Zyban, Naltrexone, or Contrave.You have been diagnosed with binge-eating disorder according to the DSM-5 guidelines.My diabetes is not currently under control.I am currently on a proven treatment plan for my eating or weight loss issues.I have gallbladder disease.My high blood pressure is not under control.I am not pregnant, breastfeeding, and I agree to use contraception.I am currently using medication for ADHD or psychostimulants.I am prone to having seizures.I do not have severe kidney, liver, nerve, lung diseases or other serious health issues.You have a history of or currently struggle with alcohol or drug addiction.I have a history of serious heart conditions or high blood pressure.I am currently taking medication for depression or strong inhibitors for CYP2D6.My thyroid condition is not under control.I have had issues with LDX or similar medications before.You have a history of an eating disorder like anorexia or bulimia, or you currently make yourself vomit regularly.My heart health is cleared by an EKG and doctor's review.My BMI is between 27-30 with a health issue related to obesity, or it's between 30 and under 50.I am not taking any medications that would interfere with the study drugs.I am between 18 and 64 years old.I can travel to New Haven, CT for weekly visits.I am currently taking opioid pain medications.I am allergic to the study medication or similar stimulants.You have a severe mental illness that requires you to stay in a hospital or get intensive treatment.You currently have thoughts of hurting yourself or others and have a plan to do so.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Naltrexone/Bupropion
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the effects of Naltrexone and Bupropion?
"Naltrexone and Bupropion is an effective treatment for not just ADHD, but also other disorders such as SAD, smoking cessation, and smoke."
Answered by AI
What are the ideal demographics for this clinical trial?
"This study is admitting 40 participants, between the ages of 18 and 64 who currently have binge-eating disorder. It is required that participants also meet the following criteria: BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50, Medically cleared as determined by EKG and medical record review, Able to travel to study location (New Haven, CT) for weekly visits, 18 to 64 years old, Available for the duration of the treatment and follow-up (18 months)."
Answered by AI
The age limit for this research is _____ years old, correct?
"The age limit for this clinical trial is 64 years old. As long as participants are over 18 years old, they are eligible for the study."
Answered by AI
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