Clinical trial NCT02335307: Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics
Official title: Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pain
CYP2D6
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Human Genome Research Institute (NHGRI)
First posted: 2015-01-09
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites for pain mangement.

Brief summary: This study will examine the effect of having genotype information on pain management and pain control for patients treated in family medicine clinics. This study will also examine physician-perceived usefulness of genotype information. Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites. Patients from implementation sites will undergo genotyping, while those from control sites will not by genotyped.

Detailed description: Codeine and tramadol are opioid analgesics that depend on cytochrome P450 2D6 (CYP2D6) for bioactivation to morphine and O-desmethyltramadol, respectively. Morphine and O-desmethyltramadol have much greater affinity for the opioid receptor and thus are more powerful analgesics.

Individuals with genotypes associated with low CYP2D6 activity (poor metabolizers) are unable to convert sufficient amounts of codeine or tramadol to their active metabolites and may fail to derive sufficient pain relief. At the opposite extreme, individuals with genotypes associated with increased CYP2D6 activity (ultra-rapid metabolizers) are at risk for serious toxicity with usual codeine or tramadol doses.

The CYP2D6 genotype also has implications for response to other drugs, such as tricyclic antidepressants (TCAs), which are commonly used for neuropathic pain.

Patients will be recruited from family medicine clinics, serving as either implementation sites or control sites. Patients from implementation sites will undergo CYP2D6 genotyping, with results placed in the medical record to assist with prescribing of pain medications. Pain medications prescribed from baseline to 3 months will be assessed through medical record review. A pain assessment questionnaire will be administered to patients enrolled from both sites at baseline and 3 months.

At the end of the study, a 20-item survey will be administered to physicians at the implementation sites. We will assess whether having CYP2D6 genotype results is useful to inform prescribing decisions for pain medication from the physician's perspective.

We will also assess medicines prescribed to patients enrolled from both sites over the 12-month period after enrollment from medical record review and determine the number of patients who were prescribed a medication that has genetic information in its FDA-approved label.

Eligibility criteria: Inclusion Criteria:

* Treated in family medicine clinic
* History of pain for at least 3 months
* Prescribed medication for pain relief

Exclusion Criteria:

* Pain for less than 3 months
* Not currently prescribed any medication for pain

Primary outcomes:
measure: Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Change in pain medication
timeFrame: Change from baseline to 3 months
measure: Change in pain score of pain intensity (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
timeFrame: Change from baseline to 3 months
measure: Change in pain score of physical functioning (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
timeFrame: Change from baseline to 3 months
measure: Change in pain score of emotional functioning
timeFrame: Change from baseline to 3 months
measure: Physician perceived usefulness of genetic information (survey)
timeFrame: 3 months
measure: Medications prescribed with pharmacogenetic implications (Percent of patients with at least one other drug (besides an opioid) where genotype information might be useful for prescribing)
timeFrame: 12 months
Other outcomes:
Locations:
city: Archer
country: United States
facility: Archer Family Health Care
state: Florida
city: Gainesville
country: United States
facility: UF Health Spring Hill Pain Management
state: Florida
city: Gainesville
country: United States
facility: UF Health Family Medicine: Hampton Oaks
state: Florida
city: Gainesville
country: United States
facility: UF Health Internal Medicine - Tower Hill
state: Florida
city: Gainesville
country: United States
facility: UF Health Family Medicine: Haile Plantation
state: Florida
city: Gainesville
country: United States
facility: UF Health Family Medicine: Main Street
state: Florida
city: Gainesville
country: United States
facility: UF Health Internal Medicine-Medical Plaza
state: Florida
city: Gainesville
country: United States
facility: UF Health Family Medicine: Eastside
state: Florida
city: Old Town
country: United States
facility: UF Health Family Medicine - Old Town
state: Florida
city: Oviedo
country: United States
facility: Oviedo Family Health Center
state: Florida
city: Saint Cloud
country: United States
facility: ProHealth Family Physicians
state: Florida
Study officials:
affiliation: University of Florida
name: Larisa Cavallari, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crews KR, Gaedigk A, Dunnenberger HM, Leeder JS, Klein TE, Caudle KE, Haidar CE, Shen DD, Callaghan JT, Sadhasivam S, Prows CA, Kharasch ED, Skaar TC; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium guidelines for cytochrome P450 2D6 genotype and codeine therapy: 2014 update. Clin Pharmacol Ther. 2014 Apr;95(4):376-82. doi: 10.1038/clpt.2013.254. Epub 2014 Jan 23.