Codeine in Sickle Cell Disease

Study Overview
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Brief Summary
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The objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease.

Detailed Description
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People with sickle cell disease require oral pain medications to manage an acute pain crisis. Sometimes these individuals fail to obtain adequate pain relief with the medications prescribed for outpatient use resulting in emergency room visits and hospital admissions. Subsequently, many patients are admitted to the hospital for pain management for a few days until the pain crisis resolves. The most common medications prescribed to sickle cell individuals for outpatient use include codeine and hydrocodone containing medications (i.e. Tylenol #3™, Vicodin™, Lortab™). These medications must be broken down in the body to make the active pain reliever (morphine or hydromorphone, respectively). Some individuals may not be able to break down these medications to the active pain reliever; therefore, these individuals will likely continue to experience pain unless they take other pain medications. We will determine whether genotype estimates the ability of CYP2D6 to break down codeine to the active pain reliever in individuals with sickle cell disease.

Official Title
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The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Drug: Codeine (30 mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years old Sickle cell disease (HbSS) Hydrocodone- or codeine-containing medications to manage an acute pain crisis in the past Exclusion Criteria: Renal dysfunction, serum creatinine (SCr) > 2.0 mg/dl Hepatic dysfunction, AST, ALT or direct bilirubin > 3 x upper limit of normal (ULN) Codeine allergy Medications shown to induce or inhibit CYP2D6 Women who are pregnant or breast feeding Unable to provide written, informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Codeine (30 mg)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma morphine and codeine concentrations |  |  | 
| CYP2D6 genotype |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease severity |  |  | 
| Hospitalizations and admissions |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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codeine, pain, CYP2D6, genotype, morphine, sickle cell, pharmacokinetic