What side effects are associated with this type of intervention?

Common treatments for eating disorders, particularly those involving opioid antagonists like naltrexone, include medications such as SSRIs, antiepileptics, and other pharmacotherapies. Known side effects of these treatments can include gastrointestinal issues (nausea, vomiting), neuropsychological effects (sedation, impaired psychomotor function), and potential interactions with other central nervous system depressants. Specifically, naltrexone may cause mood changes and psychiatric adverse events. It is important to monitor patients for these side effects and adjust treatment as necessary.

What prior FDA approvals exist?

FDA-approved treatments for eating disorders include medications such as fluoxetine and fluvoxamine, which are SSRIs used in combination with cognitive-behavioral therapy (CBT). Naltrexone, an opioid antagonist, is being studied for its potential to modulate reward pathways in eating disorders, although it is not yet FDA-approved specifically for this use. Other pharmacotherapies like topiramate and orlistat have also been explored in combination with CBT for binge eating disorder.

What other types of research exist?

Promising novel alternatives to Naltrexone for treating eating disorders include glucagon-like peptide 1 receptor agonists, such as exendin-4, which have shown potential in reducing food intake in binge eating models, and ghrelin mimetics like anamorelin, which have demonstrated efficacy in increasing energy intake and managing cachexia in cancer patients. These alternatives may offer new therapeutic options for eating disorder patients in 2024.

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Opioid Antagonist

Naltrexone for Eating Disorders (NN-RCT Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for eating disorders include cognitive-behavioral therapy (CBT), antidepressants like tricyclic antidepressants, and opioid antagonists such as Naltrexone. CBT works by addressing dysfunctional beliefs and behaviors that maintain the eating disorder, helping patients develop healthier eating patterns and coping strategies. Antidepressants can improve mood and reduce symptoms of depression and anxiety, which often co-occur with eating disorders. Naltrexone, an opioid antagonist, modulates the brain's reward pathways, potentially reducing the rewarding effects of disordered eating behaviors. Understanding these mechanisms is crucial for patients as it helps them and their healthcare providers choose the most appropriate treatment strategy, enhancing the likelihood of successful recovery.

Phase < 1

Recruiting

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up blood sampled 0-7 hours post medication

Awards & highlights

Summary

This trial tests if brain scans can show how naltrexone affects the brain in adolescents with binge/purge eating disorders. Naltrexone may help reduce harmful eating behaviors. Naltrexone is a well-tolerated drug used to help with behaviors like substance use, obesity, and eating disorders.

Who is the study for?

Adolescents and young adults aged 13-21 with an eating disorder characterized by binge eating and/or purging can join this trial. They must have a stable medication regimen, be able to give informed consent, and not be allergic to naltrexone or pregnant. Those with metal implants incompatible with MRI or recent opioid use are excluded.

What is being tested?

The study is testing if fMRI can show changes in the brain's reward system when given Naltrexone, an opioid blocker, compared to a placebo. Participants will randomly receive either Naltrexone or placebo first, then switch to the other after a period of time.

What are the potential side effects?

Naltrexone may cause nausea, headache, dizziness, fatigue, insomnia or anxiety. It might also trigger withdrawal symptoms in those who've recently used opioids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood sampled 0-7 hours post medication

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood sampled 0-7 hours post medication

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood sampled 0-7 hours post medication for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Response

Secondary study objectives

Area Under the Plasma Concentration vs. Time Curve (AUC)

Maximum Concentration in Plasma (Cmax)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group BExperimental Treatment2 Interventions

All participants will receive both naltrexone and placebo, separated by a washout period, in a randomized, crossover fashion. Those randomized to group A will receive naltrexone then placebo. Those randomized to group B will receive placebo then naltrexone.

Group II: Group AExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naltrexone

2005

Completed Phase 4

~2420

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

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

Common treatments for eating disorders include cognitive-behavioral therapy (CBT), antidepressants like tricyclic antidepressants, and opioid antagonists such as Naltrexone. CBT works by addressing dysfunctional beliefs and behaviors that maintain the eating disorder, helping patients develop healthier eating patterns and coping strategies. Antidepressants can improve mood and reduce symptoms of depression and anxiety, which often co-occur with eating disorders. Naltrexone, an opioid antagonist, modulates the brain's reward pathways, potentially reducing the rewarding effects of disordered eating behaviors. Understanding these mechanisms is crucial for patients as it helps them and their healthcare providers choose the most appropriate treatment strategy, enhancing the likelihood of successful recovery.

A comparison study of antidepressants and structured intensive group psychotherapy in the treatment of bulimia nervosa.Psychotherapy outcome research with bulimia nervosa.Integrating the twelve-step approach with traditional psychotherapy for the treatment of eating disorders.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterOTHER

488 Previous Clinical Trials

172,395 Total Patients Enrolled

1 Trials studying Eating Disorders

13 Patients Enrolled for Eating Disorders

Children's Mercy Hospital Kansas CityLead Sponsor

251 Previous Clinical Trials

930,380 Total Patients Enrolled

1 Trials studying Eating Disorders

13 Patients Enrolled for Eating Disorders

Media Library

Naltrexone (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05509257 — Phase < 1

Eating Disorders Research Study Groups: Group B, Group A

Eating Disorders Clinical Trial 2023: Naltrexone Highlights & Side Effects. Trial Name: NCT05509257 — Phase < 1

Naltrexone (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05509257 — Phase < 1

~29 spots leftby Sep 2026

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