PainIGNITENCT02335307
Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics
An observational study of Pain, run by University of Florida at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- CYP2D6 genotyping, Pain assessment questionnaire and Physician assessment
- How many people
- 505 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2015to 25 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites for pain mangement.
Who may be able to join
- Treated in family medicine clinic
- History of pain for at least 3 months
- Prescribed medication for pain relief
Who cannot join
- Pain for less than 3 months
- Not currently prescribed any medication for pain
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Archer Family Health Care
Archer, Florida, 32618
UF Health Spring Hill Pain Management
Gainesville, Florida, 32606
UF Health Family Medicine: Hampton Oaks
Gainesville, Florida, 32607
UF Health Internal Medicine - Tower Hill
Gainesville, Florida, 32607
UF Health Family Medicine: Haile Plantation
Gainesville, Florida, 32608
UF Health Family Medicine: Main Street
Gainesville, Florida, 32609'
UF Health Internal Medicine-Medical Plaza
Gainesville, Florida, 32610
UF Health Family Medicine: Eastside
Gainesville, Florida, 32641
UF Health Family Medicine - Old Town
Old Town, Florida, 32680
Oviedo Family Health Center
Oviedo, Florida, 32765
ProHealth Family Physicians
Saint Cloud, Florida, 34769
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- CYP2D6 genotyping, Pain assessment questionnaire, Physician assessment
- Keywords
- Pain, CYP2D6
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP2D6 genotypingGenetic
CYP2D6 genotype results and an interpretive report will be placed in the electronic medical record to assist the physician with prescribing medication for pain management.
Pain assessment questionnaireOther
Also called PROMIS questionnaire
A pain assessment questionnaire will be administered at baseline and 3 months.
Physician assessmentOther
20-item survey administered to physicians treating patients enrolled in the study
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients will continue to receive their current pain management therapy. In addition, a pain assessment questionnaire will be administered at baseline and 3 months. Receives: Other: Pain assessment questionnaire | |
| Implementation | Patients will undergo CYP2D6 genotyping, with results entered into the medical record to assist the physician with prescribing pain medication. In addition, a pain assessment questionnaire will be administered at baseline and 3 months. Receives: Genetic: CYP2D6 genotyping; Other: Pain assessment questionnaire | |
| Physician assessment | At the end of the study, a 20-item survey will be administered to physicians who treated patients enrolled in the study. The survey will assess whether having CYP2D6 genotype results is useful to inform prescribing decisions for pain medication from the physician's perspective. Receives: Other: Physician assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)
Patient Reported Outcomes Measurement Information System (PROMIS) measures will be used to assess pain intensity, physical functioning, and emotional functioning. There are 10 subscales on the PROMIS questionnaire that address the domains of pain, pain functioning, and emotional functioning. At least 4 (and up to 30) items are used to derive a score for each subscale. A computer adaptive version of the questionnaire based on item response theory will be used to administer the survey. A score of 0 to 100 based on survey responses will be resulted for each subscale.
Measured: Change from baseline to 3 months
Secondary outcomes (6)
Change in pain medication
Change in pain medication will be evaluated in several manners: change in the opiate prescribed, change from an opiate to a non-opiate; and change in dose of the opiate prescribed
Measured: Change from baseline to 3 months
Change in pain score of pain intensity (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Patient Reported Outcomes Measurement Information System (PROMIS) subscale for pain intensity, with the score ranging from 0 to 100 resulting.
Measured: Change from baseline to 3 months
Change in pain score of physical functioning (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Patient Reported Outcomes Measurement Information System (PROMIS) subscales for physical functioning include pain function, pain interference, pain behavior, sleep disturbance, and sleep-related impairment. A score of 0 to 100 based on survey responses will be resulted for each subscale.
Measured: Change from baseline to 3 months
Change in pain score of emotional functioning
Patient Reported Outcomes Measurement Information System (PROMIS) subscales for emotional functioning include fatigue, anxiety, depression, and anger. A score of 0 to 100 based on survey responses will be resulted for each subscale.
Measured: Change from baseline to 3 months
Physician perceived usefulness of genetic information (survey)
Survey will be administered to physicians with patients in the study to assess the effect of having genotype information on their prescribing decisions.
Measured: 3 months
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)
Percent of patients with at least one other drug (besides an opioid) where genotype information might be useful for prescribing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startJun 2015
- Primary completion12 Jun 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Larisa Cavallari, PharmD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335307
- Sponsor's protocol ID
- IRB201400501 - N
- Other IDs
- U01HG007269-02, OCR14741
- Acronym
- IGNITE
- Status last verified
- Jun 2019
- First submitted
- 7 Jan 2015
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The consent form has an addendum for NIH dbGaP. Participants who agree will have their deidentified results shared to dbGaP. Those who do not agree will not have their results shared.
Publications
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.
PubMed 24458010
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics
- ClinicalTrials.gov ID
- NCT02335307
- Acronym / sponsor ID
- IGNITE / IRB201400501 - N
- Conditions
- Pain
- Keywords
- Pain, CYP2D6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- Jun 2015 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 9 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Pain assessment questionnairePatients will continue to receive their current pain management therapy. In addition, a pain assessment questionnaire will be administered at baseline and 3 months. |
| Implementation | – | Genetic: CYP2D6 genotyping, Other: Pain assessment questionnairePatients will undergo CYP2D6 genotyping, with results entered into the medical record to assist the physician with prescribing pain medication. In addition, a pain assessment questionnaire will be administered at baseline and 3 months. |
| Physician assessment | – | Other: Physician assessmentAt the end of the study, a 20-item survey will be administered to physicians who treated patients enrolled in the study. The survey will assess whether having CYP2D6 genotype results is useful to inform prescribing decisions for pain medication from the physician's perspective. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites for pain mangement.
Key inclusion criteria (3 listed)
- Treated in family medicine clinic
- History of pain for at least 3 months
- Prescribed medication for pain relief
Key exclusion criteria (2 listed)
- Pain for less than 3 months
- Not currently prescribed any medication for pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYP2D6 genotypingCYP2D6 genotype results and an interpretive report will be placed in the electronic medical record to assist the physician with prescribing medication for pain management. | Genetic | Implementation |
| Pain assessment questionnaireAlso: PROMIS questionnaireA pain assessment questionnaire will be administered at baseline and 3 months. | Other | Control, Implementation |
| Physician assessment20-item survey administered to physicians treating patients enrolled in the study | Other | Physician assessment |
Primary outcome
Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: Change from baseline to 3 months
Patient Reported Outcomes Measurement Information System (PROMIS) measures will be used to assess pain intensity, physical functioning, and emotional functioning. There are 10 subscales on the PROMIS questionnaire that address the domains of pain, pain functioning, and emotional functioning. At least 4 (and up to 30) items are used to derive a score for each subscale. A computer adaptive version of the questionnaire based on item response theory will be used to administer the survey. A score of 0 to 100 based on survey responses will be resulted for each subscale.
6 secondary outcomes
Change in pain medication
Time frame: Change from baseline to 3 months
Change in pain score of pain intensity (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Time frame: Change from baseline to 3 months
Change in pain score of physical functioning (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Time frame: Change from baseline to 3 months
Change in pain score of emotional functioning
Time frame: Change from baseline to 3 months
Physician perceived usefulness of genetic information (survey)
Time frame: 3 months
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)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Background: PubMed 24458010Crews 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.
- Individual participant dataSharing planned: Yes. The consent form has an addendum for NIH dbGaP. Participants who agree will have their deidentified results shared to dbGaP. Those who do not agree will not have their results shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larisa Cavallari, PharmD principal investigator
University of Florida
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by University of Florida at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS) (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02335307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.