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
Cite this record
ConductScience Library. Naltrexone Neuroimaging. Trials, record NCT04935931. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04935931
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens | 2 hours post-naltrexone vs baseline | Change in %BOLD following single dose naltrexone (post-pre) within individuals during passive food view task in the nucleus accumbens |
| Primary | Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate Cortex | 2 hours post-naltrexone vs baseline | Change in %BOLD following single dose naltrexone (post-pre) within individuals during monetary incentive delay in dorsal anterior cingulate cortex |
| Secondary | Exposure | 2 hours post-naltrexone | Maximum plasma concentration of naltrexone at 2 hours post-single dose |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens | 2 hours post-naltrexone vs baseline | %BOLD signal change | MEAN | |
| PRIMARY | Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate Cortex | 2 hours post-naltrexone vs baseline | %BOLD signal change | MEAN | |
| SECONDARY | Exposure | 2 hours post-naltrexone | plasma concentration | nanomolar | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens | Single Pre/Post Design | -0.08 | Standard Deviation 0.03 | %BOLD signal change | |
| Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate Cortex | Single Pre/Post Design | 0.06 | Standard Deviation 0.03 | %BOLD signal change | |
| Exposure | Single Pre/Post Design | 44.1 | Standard Deviation 22.7 | nanomolar |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Pre/Post Design | 13 | |
| Overall Study | COMPLETED | Single Pre/Post Design | 12 | |
| Overall Study | NOT COMPLETED | Single Pre/Post Design | 1 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Claustrophobia | Nervous system disorders | Single Pre/Post Design | 1 | 13 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Pre/Post Design | 0 | 13 |
| Total, other adverse events | Single Pre/Post Design | 1 | 13 |
| Total, serious adverse events | Single Pre/Post Design | 0 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37492067 | DERIVED |
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR002366 | Frontiers Clinical and Translational Science Institute at the University of Kansas | CASTRO, MARIO; LEEDER, JAMES STEVEN | UNIVERSITY OF KANSAS MEDICAL CENTER | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2017 to 2025 |
Source NIH RePORTER
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.
| Test | Named as |
|---|---|
| Monetary Incentive Delay | Primary outcome |
Source ConductCognition
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