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Trial · NCT04935931

Naltrexone Neuroimaging

NCT04935931, Early phase 1, Completed, Children's Mercy Hospital Kansas City; results first posted 2023-08-21

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Naltrexone Neuroimaging. Trials, record NCT04935931. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04935931

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Naltrexone Neuroimaging
NCT number
NCT04935931
Status
Completed
Phases
Early phase 1
Enrollment
13 participants, actual
Lead sponsor
Children's Mercy Hospital Kansas City
Conditions
Eating Disorders, Binge Eating, Purging (Eating Disorders)
Interventions
Naltrexone
First posted
2021-06-23
Last updated
2023-10-12
Results first posted
2023-08-21

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens2 hours post-naltrexone vs baselineChange in %BOLD following single dose naltrexone (post-pre) within individuals during passive food view task in the nucleus accumbens
PrimaryChange in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate Cortex2 hours post-naltrexone vs baselineChange in %BOLD following single dose naltrexone (post-pre) within individuals during monetary incentive delay in dorsal anterior cingulate cortex
SecondaryExposure2 hours post-naltrexoneMaximum plasma concentration of naltrexone at 2 hours post-single dose

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens2 hours post-naltrexone vs baseline%BOLD signal changeMEAN
PRIMARYChange in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate Cortex2 hours post-naltrexone vs baseline%BOLD signal changeMEAN
SECONDARYExposure2 hours post-naltrexoneplasma concentrationnanomolarMEAN

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus AccumbensSingle Pre/Post Design-0.08Standard Deviation 0.03%BOLD signal change
Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate CortexSingle Pre/Post Design0.06Standard Deviation 0.03%BOLD signal change
ExposureSingle Pre/Post Design44.1Standard Deviation 22.7nanomolar

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDSingle Pre/Post Design13
Overall StudyCOMPLETEDSingle Pre/Post Design12
Overall StudyNOT COMPLETEDSingle Pre/Post Design1

Adverse events1

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherClaustrophobiaNervous system disordersSingle Pre/Post Design1131

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalitySingle Pre/Post Design013
Total, other adverse eventsSingle Pre/Post Design113
Total, serious adverse eventsSingle Pre/Post Design013

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
37492067DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
UL1TR002366Frontiers Clinical and Translational Science Institute at the University of KansasCASTRO, MARIO; LEEDER, JAMES STEVENUNIVERSITY OF KANSAS MEDICAL CENTERNATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES2017 to 2025

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed as
Monetary Incentive DelayPrimary outcome

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04935931

GET https://conductscience.org/api/trials/v1/NCT04935931/registered