Sickle Cell DiseaseMSCDNCT00761085
Methadone in Pediatric and Adult Sickle Cell Patients
A study testing Morphine and Methadone in people with Sickle Cell Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode. Read more about this study
- Who is it for?
- Ages 7 to 40 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Morphine and Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2008to 7 Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Greater than or equal to 7 years and less than or equal to 40 years
- Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
- Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
- Admitted to the inpatient unit for further treatment
- Started on morphine patient controlled analgesia and infusion for pain management
Who cannot join
- Diagnosis of acute chest syndrome
- New focal neurologic findings or clinical concern of stroke
- Aplastic crisis with hemoglobin 2 g/dl below steady-state value
- Allergy to morphine or methadone
- Any other medical condition that the attending physician deems to be a contraindication to therapy
- Liver or renal insufficiency or failure, and congestive heart failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Barnes Jewish Hospital/St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.
- Conditions
- Sickle Cell Disease
- Being tested
- Morphine, Methadone
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Standard of care for pain management of acute episode of pain
MethadoneDrug
Compare to standard of care for pain management of acute episode of pain
| Study group | Role | What they receive |
|---|---|---|
| Methadone-Children | Active comparator | Methadone comparison to standard of care for pain management Receives: Drug: Methadone |
| Morphine-Children | Active comparator | Morphine standard of Care pain management Receives: Drug: Morphine |
| Methadone-Adults | Active comparator | Methadone comparison to standard of care for pain management Receives: Drug: Methadone |
| Morphine-Adults | Active comparator | Morphine standard of Care pain management Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
R-Methadone AUC
Measured: 96 hr
Secondary outcomes (1)
Pain Relief
Pain relief score using the 10CM VAS, which has a pain scale of 0-10, with 0=no pain and 10=worst pain experienced
Measured: 72 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study start1 Jan 2008
- Primary completion7 Nov 2010
- Study completion7 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan D Kharasch, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761085
- Sponsor's protocol ID
- 201107091
- Acronym
- MSCD
- Status last verified
- Jan 2020
- First submitted
- 24 Sep 2008
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Horst J, Frei-Jones M, Deych E, Shannon W, Kharasch ED. Pharmacokinetics and analgesic effects of methadone in children and adults with sickle cell disease. Pediatr Blood Cancer. 2016 Dec;63(12):2123-2130. doi: 10.1002/pbc.26207. Epub 2016 Aug 30.
PubMed 27572136
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone in Pediatric and Adult Sickle Cell Patients
- ClinicalTrials.gov ID
- NCT00761085
- Acronym / sponsor ID
- MSCD / 201107091
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 7 Nov 2010 (actual)
- Study completion
- 7 Nov 2010 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Methadone-Children | Active comparator | Drug: MethadoneMethadone comparison to standard of care for pain management |
| Morphine-Children | Active comparator | Drug: MorphineMorphine standard of Care pain management |
| Methadone-Adults | Active comparator | Drug: MethadoneMethadone comparison to standard of care for pain management |
| Morphine-Adults | Active comparator | Drug: MorphineMorphine standard of Care pain management |
Who may qualify
- Ages
- 7 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Greater than or equal to 7 years and less than or equal to 40 years
- Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
- Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
- Admitted to the inpatient unit for further treatment
- Started on morphine patient controlled analgesia and infusion for pain management
Key exclusion criteria (6 listed)
- Diagnosis of acute chest syndrome
- New focal neurologic findings or clinical concern of stroke
- Aplastic crisis with hemoglobin 2 g/dl below steady-state value
- Allergy to morphine or methadone
- Any other medical condition that the attending physician deems to be a contraindication to therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineStandard of care for pain management of acute episode of pain | Drug | Morphine-Adults, Morphine-Children |
| MethadoneCompare to standard of care for pain management of acute episode of pain | Drug | Methadone-Adults, Methadone-Children |
Primary outcome
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
Time frame: 96 hr
R-Methadone AUC
1 secondary outcome
Pain Relief
Time frame: 72 hr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27572136Horst J, Frei-Jones M, Deych E, Shannon W, Kharasch ED. Pharmacokinetics and analgesic effects of methadone in children and adults with sickle cell disease. Pediatr Blood Cancer. 2016 Dec;63(12):2123-2130. doi: 10.1002/pbc.26207. Epub 2016 Aug 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan D Kharasch, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine and Methadone in people with Sickle Cell Disease, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. (time frame: 96 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00761085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.