Health TrialsbyHealthPanel

Naltrexone Neuroimaging in Teens With Eating Disorders

ConditionsEating DisordersBinge EatingPurging (Eating Disorders)Bulimia NervosaAnorexia Nervosa, Atypical
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age13-21
SponsorChildren's Mercy Hospital Kansas City

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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, Other Specified Feeding/Eating Disorder) using Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria.

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Response

Acute %Blood oxygenation level dependent (BOLD) change placebo vs. naltrexone in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex)

Time frame
2 hours post medication (naltrexone or placebo)

Secondary outcomes

1

Maximum Concentration in Plasma (Cmax)

Naltrexone systemic exposure defined by the pharmacokinetic parameter Cmax

Time frame
Blood sampled 0-7 hours post medication
2

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

Naltrexone systemic exposure defined by the pharmacokinetic parameter AUC

Time frame
Blood sampled 0-7 hours post medication

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Mercy Hospital Kansas City

Lead sponsor

University of Kansas Medical Center

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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