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New treatment option for Eating Disorders
Official title Naltrexone Neuroimaging in Teens With Eating Disorders
ClinicalTrials.gov ID: NCT05509257
What this study is testing
What is Naltrexone?
Naltrexone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for eating disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Using a randomized, placebo-controlled, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders. The hypothesis is that fMRI will be able to detect acute reward pathway modulation by naltrexone (an opioid antagonist) in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 21
You may be able to join if
- Adolescents and young adults aged 13-21 years
- Eating disorder diagnosis characterized by binge eating and/or purging (eg, Anorexia Nervosa-Binge/Purge, Bulimia Nervosa, Binge Eating Disorder...
- Stable medication regimen (no dose or drug changes in the past 4 weeks)
- Participant and parent/legal guardian (if under 18 years) are willing and able to provide informed permission/assent/consent for the study
You likely can't join if
- Pregnant (via UCG)
- Prior hypersensitivity reaction to naltrexone (e.g., anaphylaxis)
- Non-removable metal in the body that is magnetic resonance imaging incompatible
- Current naltrexone use
- Self-reported opioid use in the past 7 days
- A language barrier (e.g., non-English speaking) for the participant that precludes communication and/or ability to complete all study-related...
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.