Assessment of Opioid Analgesia in Sickle Cell

Withdrawn before enrolling · Phase 4

Conditions studied: Sickle Cell Disease

In brief

To develop and validate a non-invasive, in vivo, phenotyping method for CYP2D6 using the non-injurious neuroselective electrical stimulation technique: pain perception threshold/pain tolerance threshold (PPT/PTT) in children and adolescents with sickle cell disease.

Key facts

Study ID

NCT00513864

Run by

Children's National Research Institute

People needed

0

Starts

2006-11-01

Expected to finish

2012-03-01

Last updated by the study team

2014-12-23

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is 7 to 18 years of age
• The subject is of African American descent
• The subject has sickle cell disease (HbSS)
• The subject has a history of vaso-occlusive crisis occurring within the 6 months prior to enrollment requiring opioid analgesia use
• The subject is willing to remain at the research site for the duration of each study session.
• The subject's parent / legal guardian has provided written informed consent to study participation
• The subject has provided written assent to study participation

You may not qualify if…

• The subject is a pregnant or lactation female (if post-menarchal, a negative pregnancy test must be confirmed on the day that any drug is administered (i.e., morphine, dextromethorphan or codeine)
• The subject has a history of smoking
• The subject has a history of alcohol use within the last 24 hours prior to testing session(s)
• The subject has a medical history of neuropathic pain, gastrointestinal, hepatic or renal disease
• The subject has a history of medication use including herbal therapies that are known to inhibit or induce CYP2D6 or morphine
• The subject has known or suspected hypersensitivities / allergies to codeine, morphine or dextromethorphan
• The subject is in active, vaso-occlusive crisis

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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