Naltrexone Neuroimaging in Teens With Eating Disorders

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Children's Mercy Hospital Kansas City
Study ID
NCT05509257
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Anorexia Nervosa, Atypical
  • Binge Eating
  • Bulimia Nervosa
  • Eating Disorders
  • Purging (Eating Disorders)

Eligibility Criteria

Sex
ALL
Age
13 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Naltrexone — DRUG
    Participants will receive a single oral dose in randomized, crossover fashion with a 2 week wash out period between interventions. Medication will be taken 2 hours prior the neuroimaging.
  • Placebo — DRUG
    Participants will receive a single oral dose of medication in randomized, crossover fashion with a 2 week wash out period between interventions.. Medication will be taken 2 hours prior the neuroimaging.

Study Details

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).

Key Dates

Start date
Sep 17, 2022
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Group A
    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.
  • Experimental: Group B
    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.

Primary Outcome Measure

Response [ Time Frame: 2 hours post medication (naltrexone or placebo) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Mercy Research InstituteKansas CityMissouri64108
Mariah Brewe, BA
[email protected]
(816) 916-3409
Stephani L Stancil, PhD, APRN (PRINCIPAL_INVESTIGATOR)

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Children's Mercy Research Institute· Kansas City, MO

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