Assessment of Opioid Analgesia in Sickle Cell

NCT00513864 | Withdrawn Phase 4 DMC

• 1 other identifier: 3919
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sickle Cell Disease

Keywords

Opioid Analgesics; Morphine; Codeine; Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Pain Tolerance Threshold

  5 measurements over 8 hours; 2 separate days

  5 seconds

Study Arms (2)

CYP2D6-

ACTIVE COMPARATOR

This arm consists of subjects that are poor metabolizers (PM) and intermediate metabolizers (IM).

Drug: Dextromethorphan; Drug: Codeine; Drug: Morphine

CYP2D6+

ACTIVE COMPARATOR

Extensive metabolizers (EM) of codeine

Drug: Dextromethorphan; Drug: Codeine; Drug: Morphine

Interventions

Dextromethorphan DRUG

one time dose - 0.3mg/kg PO

Also known as: (+)-3-methoxy-17-methyl-9α,13α,14α-morphinan, DXM

CYP2D6+; CYP2D6-

Codeine DRUG

one time dose - 2mg/kg PO

Also known as: 3-methylmorphine

CYP2D6+; CYP2D6-

Morphine DRUG

one time dose - 0.15mg/kg IV

Also known as: MS Contin, MSIR

CYP2D6+; CYP2D6-

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Dextromethorphan; Codeine; Morphine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives

Study Officials

• Julia C. Finkel, M.D.

  Children's National Medical Center-PPRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: November 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (1)