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Opioid Antagonist
Naltrexone for Eating Disorders (NN-RCT Trial)
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
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
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
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.
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
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.
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
517 Previous Clinical Trials
177,381 Total Patients Enrolled
1 Trials studying Bulimia
13 Patients Enrolled for Bulimia
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,751,581 Total Patients Enrolled
37 Trials studying Bulimia
42,203 Patients Enrolled for Bulimia
Children's Mercy Hospital Kansas CityLead Sponsor
257 Previous Clinical Trials
940,436 Total Patients Enrolled
1 Trials studying Bulimia
13 Patients Enrolled for Bulimia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking naltrexone.I have been diagnosed with an eating disorder that involves binge eating or purging.My medications have not changed in the last 4 weeks.I am between 13 and 21 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Group B
- Group 2: Group A
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.