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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two medications, naltrexone and bupropion, to determine if they help people with binge-eating disorder (BED) and obesity more effectively than a placebo. BED involves consuming large amounts of food quickly and feeling out of control. The study targets individuals who haven’t found success with other treatments. It might be suitable for those with BED, a BMI over 27, and the ability to travel to New Haven, CT, for weekly visits. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

Yes, you may need to stop certain medications to join the trial. Specifically, you cannot be using psychostimulants, ADHD medications, the study medications (naltrexone or bupropion), MAOIs, SSRIs, strong inhibitors of CYP2D6, opioid pain medications, or any effective treatment for eating or weight loss.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of naltrexone and bupropion (NB) is generally safe for individuals with both binge-eating disorder (BED) and obesity. One study found that patients using this treatment did not experience major safety issues, and most managed the medication well. The FDA has approved this drug combination for treating obesity, indicating its safety. While side effects can occur, as with any medication, previous studies have shown that serious problems are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for binge eating disorder and obesity, which often focus on diet changes, therapy, or medications like SSRIs, the combination of Naltrexone and Bupropion offers a unique approach by targeting both the brain's reward system and appetite regulation. Naltrexone reduces cravings by blocking opioid receptors, while Bupropion enhances dopamine activity to help control the urge to binge eat. This dual-action mechanism is what has researchers excited, as it addresses both the psychological and physiological aspects of these conditions in a way that standard treatments do not.

What evidence suggests that this trial's treatments could be effective for binge-eating disorder and obesity?

This trial will evaluate the combination of naltrexone and bupropion (NB) for its effectiveness in treating binge eating disorder (BED) and obesity. Studies have shown that NB can help people with obesity lose weight and lower their body mass index (BMI), and the FDA has approved it for treating obesity. For those with BED, early research indicates that NB might help reduce binge eating episodes in individuals who are also obese. Although some initial studies did not show significant results, the treatment was generally well-tolerated, suggesting it could benefit those dealing with both BED and obesity. Participants in this trial may receive either the NB combination or a placebo. ^{1 2 4 5 6}

Who Is on the Research Team?

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

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 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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474691/

Efficacy of naltrexone and bupropion combination in ... The findings indicated that NB treatment led to statistically significant reductions in both body weight and BMI when compared to control ...

2. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20220267

Naltrexone-Bupropion and Behavior Therapy, Alone ... Trials have found naltrexone-bupropion effective for obesity (25, 26), leading to FDA approval (22), and one trial found that it significantly ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02317744

Treatment of Binge Eating Disorder in Obesity: Naltrexone ... This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000142

Appropriate use of the fixed-dose, extended-release ... NB-ER is approved for the treatment of patients with obesity, with studies showing that patients can achieve significant weight reduction compared with placebo.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33218742/

Naltrexone + Bupropion Combination for the Treatment of ... The findings from this pilot RCT suggest that NB was well-tolerated in these patients with BED and comorbid obesity. Most outcomes were not ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7902424/

Naltrexone + Bupropion Combination for the Treatment ... The findings from this pilot RCT suggest that NB was well-tolerated in these patients with BED and comorbid obesity. Most outcomes were not statistically ...