CompletedNCT00761085MSCDUpdated Jan 22, 2020Results posted

Methadone in Pediatric and Adult Sickle Cell Patients

An interventional study of Morphine and Methadone in Sickle Cell Disease, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 7 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 8 months after the study started (first participant enrolled Jan 2008, registered Sep 2008).

Phase: Not applicable
Study type: Interventional
Enrollment: 47
Allocation: Randomized
Ages: 7 Years to 40 Years
Sex: All

Study summary

To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.

Conditions studied

Sickle Cell Disease

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Anemia, Sickle Cell 1,103

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's enrollment of 47 is above the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.

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Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 7 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 47 participants (actual)

Study arms

Active comparator
Methadone-Children
Methadone comparison to standard of care for pain management
Drug: Methadone
Active comparator
Morphine-Children
Morphine standard of Care pain management
Drug: Morphine
Active comparator
Methadone-Adults
Methadone comparison to standard of care for pain management
Drug: Methadone
Active comparator
Morphine-Adults
Morphine standard of Care pain management
Drug: Morphine

Interventions

DrugMorphine
Standard of care for pain management of acute episode of pain
DrugMethadone
Compare to standard of care for pain management of acute episode of pain

What researchers measure

Primary outcomes

To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
R-Methadone AUC
Time frame: 96 hr

Secondary outcomes

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
Time frame: 72 hr

Results

Posted Jan 22, 2020

Participant flow

Participant flow — Overall Study
Milestone	Methadone-Children	Morphine-Children	Methadone-Adults	Morphine-Adults
Started	12	12	11	12
Completed	12	6	11	8
Not completed	0	6	0	4

Outcome measures

PrimaryTo Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.

R-Methadone AUC

Time frame:: 96 hr
Reported as:: Mean · (hr*ng/ml)

To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
(hr*ng/ml)	Methadone-Children	Morphine-Children	Methadone-Adults	Morphine-Adults
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.	523 ± 248	0 ± 0	637 ± 324	0 ± 0

Statistical analysis

Methadone-Children vs Morphine-Children vs Methadone-Adults vs Morphine-Adults ·

SecondaryPain 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

Time frame:: 72 hr
Reported as:: Mean · units on a scale

Pain Relief
units on a scale	Methadone-Children	Morphine-Children	Methadone-Adults	Morphine-Adults
Pain Relief	8 ± 2	4 ± 3	5 ± 3	5 ± 2

Statistical analysis

Methadone-Children vs Morphine-Children vs Methadone-Adults vs Morphine-Adults · ANOVA · p = <0.05

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Methadone-Children	0/12 (0%)	0/12 (0%)	0/12 (0%)
Morphine-Children	0/12 (0%)	0/12 (0%)	0/12 (0%)
Methadone-Adults	0/11 (0%)	0/11 (0%)	0/11 (0%)
Morphine-Adults	0/12 (0%)	0/12 (0%)	0/12 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Methadone-Children	Morphine-Children	Methadone-Adults	Morphine-Adults	Total
Mean	15 ± 2	14 ± 3	25 ± 6	25 ± 7	22 ± 5

Sex: Female, Male
Sex: Female, Male(Participants)	Methadone-Children	Morphine-Children	Methadone-Adults	Morphine-Adults	Total
Female	4	5	7	7	23
Male	8	7	4	5	24

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Methadone-Children	Morphine-Children	Methadone-Adults	Morphine-Adults	Total
Count of participants	—	—	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Methadone-Children	Morphine-Children	Methadone-Adults	Morphine-Adults	Total
United States	12	12	11	12	47

Study locations

1 site

Barnes Jewish Hospital/St. Louis Children's Hospital
Saint Louis, Missouri 63110, United States

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00761085
Lead sponsor: Washington University School of Medicine
Responsible party: Sponsor
First posted: Sep 26, 2008
Start date: Jan 1, 2008
Primary completion: Nov 7, 2010
Completion: Nov 7, 2010
Results posted: Jan 22, 2020
Last update: Jan 22, 2020

Study contacts

Evan D Kharasch, MD, PhD

principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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