Trial · NCT06940570
Methadone as an Alternative Treatment for Children Underdoing HSCT
NCT06940570, Phase 3, Suspended, University of Texas Southwestern Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Methadone as an Alternative Treatment for Children Underdoing HSCT. Trials, record NCT06940570. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06940570
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methadone as an Alternative Treatment for Children Underdoing HSCT
- NCT number
- NCT06940570
- Status
- Suspended
- Phases
- Phase 3
- Enrollment
- 60 participants, estimated
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Leukemia, Aplastic Anemia, Bone Marrow Failure Syndromes, SCID
- Interventions
- PCA plus methadone (Experimental), PCA Alone (SOC)
- First posted
- 2025-04-23
- Last updated
- 2025-10-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction of pain score | Daily after completion of conditioning (day +7 to day +14) through discharge (approximately day +60) | The purpose of the study is to compare methadone versus standard of care at this center of morphine/hydromorphone PCA and see if methadone is superior to the standard of care as evidenced by reduction in pain scores during inpatient transplant. To determine whether concomitant administration of intravenous administered methadone with on demand opioid PCA will improve pain score numbers in the PCA/methadone arm by 25% in comparison to a continuous infusion PCA with demand opioid arm. |
| Secondary | REDUCTION OF OPIOID RECEIVED as evidenced by 25% reduction of MME in experimental arm in comparison to control arm | Daily after completion of conditioning (day +7 to day +14) through discharge (approximately day +60) | To determine if methadone (starting dose of 0.1 mg/kg IV Q8hr) with increased titration will result in a reduction of 25% in total morphine milligram equivalents (MME) per day in children who have mucositis following ablative conditioning and subsequent allogeneic or autologous HSCT |
| Secondary | IMPROVEMENT OF FUNCTIONALITY as evidenced by higher functionality scores in experimental arm in comparison to control | Day 0 (stem cell infusion) | To determine how administration of methadone affects functionality during transplantation period |
| Secondary | REDUCED NUMBER OF DAYS ON PARENTERAL NUTRITION as evidenced by reduced number of TPN days in experimental arm in comparison to control | From enrollment (initiation of TPN- typically on day +1) to engraftment day AND date when able to take solid food again (day just prior to discharge-approx. day+50 to day+60) | To determine if the overall TPN days are reduced during hospital stay in experimental arm as compared to the standard PCA regimen |
| Secondary | INCREASED RETURN TO ORAL LIQUID INTAKE as evidenced by more rapid return to tolerating clears in experimental group versus control | From enrollment (initiation of TPN- typically on day +1) to engraftment day AND date when able to take solid food again (day just prior to discharge-approx. day+50 to day+60) | To determine if child resumes oral intake more rapidly compared to control arm |
| Secondary | Adverse events | From first dose of methadone administered (day +1- day +7) until prior to discharge (approximately day +60) | To describe adverse events and incidence associated with methadone when administered in combination with morphine or hydromorphone, specifically QTc prolongation that has been documented with study medication |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers37
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT06940570
GET https://conductscience.org/api/trials/v1/NCT06940570/papers?page=2