What side effects are associated with this type of intervention?

Common treatments for Binge Eating Disorder (BED) similar to the combination of Naltrexone/Bupropion can have several side effects. Naltrexone, an opioid antagonist, may cause nausea, headache, dizziness, and fatigue. Bupropion, a norepinephrine-dopamine reuptake inhibitor, can lead to insomnia, dry mouth, headache, and an increased risk of seizures. When combined, these medications may also pose cardiovascular risks, though the data is not fully conclusive. Monitoring for increased suicidal ideation is also recommended, particularly in younger adults.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Binge Eating Disorder (BED). One notable combination is naltrexone/bupropion, where naltrexone reduces cravings and bupropion helps with weight loss and mood regulation. This combination has shown effectiveness in managing BED symptoms. Additionally, other medications like lisdexamfetamine dimesylate (Vyvanse) have been approved specifically for BED, focusing on reducing binge episodes. These treatments, along with behavioral therapies, form a comprehensive approach to managing BED.

What other types of research exist?

Promising novel alternatives to Naltrexone/Bupropion for Binge Eating Disorder include cognitive behavioral therapy (CBT) guided self-help combined with orlistat, and higher doses of selective serotonin reuptake inhibitors (SSRIs) like fluoxetine. These treatments have shown efficacy in randomized controlled trials for BED.

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Medication + Behavioral Therapy for Post-Bariatric Surgery Weight Control

Phase 2 & 3

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be in the age range ≥18 years of age and ≤70 years of age

Be in the age range ≥18 years of age and ≤70 years of age.

Must not have

Has untreated hypertension with a seated systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg, or heart rate > 100 beats/minute

Is currently in active treatment for eating or weight loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment (4 months)

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

This trial will test different treatments for people who have trouble controlling their eating and weight after weight-loss surgery. The treatments include behavior therapy to change eating habits and a combination of two medications to reduce cravings. The goal is to find out which approach works best for these patients.

Who is the study for?

Adults aged 18-70 who've had bariatric surgery (gastric bypass or sleeve gastrectomy) about six months ago, with a BMI of 30-50 (or ≥27 if they have certain health issues), experiencing weekly loss-of-control eating. They must be generally healthy, not on weight loss or contraindicated meds, and able to commit to up to 19 months in the study.

What is being tested?

The trial is testing how well behavioral weight loss strategies work compared to or combined with Naltrexone/Bupropion medication for controlling eating and managing weight after bariatric surgery. Participants will either receive the drug combo, placebo, or just behavioral therapy.

What are the potential side effects?

Naltrexone/Bupropion can cause nausea, headaches, constipation, dizziness, insomnia and dry mouth. There's also a risk for more serious effects like high blood pressure and seizures especially in those predisposed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I am between 18 and 70 years old.

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I have had weight loss surgery.

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My BMI is between 27 and 50, and I may have a health condition if it's under 30.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure or heart rate is higher than normal and untreated.

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I am currently receiving treatment for an eating disorder or to lose weight.

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I have struggled with drug or alcohol dependence after my weight loss surgery.

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I am not on medications like MAOIs or opiates that conflict with NB medication.

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My thyroid is underactive and not yet treated, confirmed by two tests.

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My high blood pressure is not under control.

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I am currently taking medication to lose weight.

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I have a history of heart disease, arrhythmias needing medication, or stroke.

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My diabetes is not currently under control.

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I have gallbladder disease.

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I have a history of severe kidney, liver, nerve, lung diseases, or other unstable conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment (4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment (4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment (4 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Mass Index

Loss-of-control Eating Frequency

Secondary study objectives

Depressive Symptoms

Eating Disorder Psychopathology

Loss-of-control Eating Remission

+1 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: NB medicationExperimental Treatment1 Intervention

Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.

Group II: Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medicationExperimental Treatment2 Interventions

Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.

Group III: BWL + PlaceboExperimental Treatment2 Interventions

Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.

Group IV: PlaceboPlacebo Group1 Intervention

Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Weight Loss

2011

Completed Phase 2

~380

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Binge Eating Disorder (BED) include pharmacological and behavioral therapies. Naltrexone/bupropion combines an opioid antagonist that reduces cravings (naltrexone) with a norepinephrine-dopamine reuptake inhibitor that aids in weight loss and mood regulation (bupropion). This combination helps manage the compulsive eating and emotional dysregulation seen in BED. Cognitive Behavioral Therapy (CBT) is another cornerstone treatment that addresses the dysfunctional thoughts and behaviors associated with binge eating. Other pharmacotherapies like lisdexamfetamine, a stimulant that reduces appetite, and topiramate, an anticonvulsant that decreases binge frequency, also play significant roles. These treatments are crucial as they target the underlying neurobiological and psychological factors of BED, providing comprehensive management of the disorder.

New-generation anti-obesity drugs: naltrexone/bupropion and liraglutide. An update for endocrinologists and nutritionists.Centrally Acting Agents for Obesity: Past, Present, and Future.