Early Phase 1
N=13
Naltrexone Neuroimaging
Eating Disorders · Binge Eating · Purging (Eating Disorders)
Bottom Line
View on ClinicalTrials.gov: NCT04935931 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens — -0.08 %BOLD signal change
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Naltrexone (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens |
-0.08 | — |
| PRIMARY Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate Cortex |
0.06 | — |
| SECONDARY Exposure |
44.1 | — |
Summary
The purpose of this open-label, pilot study is to evaluate fMRI as a biomarker of opioid antagonism in adolescents with ED. Modulation of brain activation will be examined in regions of interest by fMRI using a food-specific and general reward task in adolescents with ED in a pre/post design.
Eligibility Criteria
Inclusion Criteria
- Eating disorder diagnosis per DSM-V criteria that is characterized by binge eating (defined as loss of control of eating resulting in large amount of food consumed in a short period of time) and/or purging (e.g., vomiting, excessive exercising, laxative use)
- 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
Exclusion Criteria
- Pregnant (via UCG)
- Prior hypersensitivity reaction to naltrexone (e.g., anaphylaxis)
- Non-removable metal in the body
- 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 requirements.
Data sourced from ClinicalTrials.gov (NCT04935931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.