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Pharmacogenetic Testing for Acute Pain Management (ADOPT PGx Trial)
N/A
Waitlist Available
Led By Hrishikesh Chakraborty
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 8 years
Age ≥ 18 years
Must not have
Trial-wide: Life expectancy less than 12 months, Are too cognitively impaired to provide informed consent and/or complete study protocol, Are institutionalized or too ill to participate, Have a history of allogeneic stem cell transplant or liver transplant, People with prior clinical pharmacogenetic test results for genes relevant for the study in which they will enroll or already enrolled in an ADOPT PGx trial
Acute Pain: Undergoing a laparoscopic surgery, Receiving chronic opioid therapy, defined as use of opioids on most days for >3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether or not personalized medicine based on genetic testing can improve pain control and management for people who have surgery.
Who is the study for?
This trial is for English or Spanish speakers with chronic pain, acute post-surgical pain, or depression. Adults and children over 8 years old may qualify if they are being considered for treatment with certain opioids (tramadol, hydrocodone, codeine) or SSRIs. Exclusions include life expectancy under 12 months, cognitive impairment preventing consent, institutionalization, organ transplant history, prior pharmacogenetic testing relevant to the study.
What is being tested?
The trials test whether genetic testing can guide better pain management after surgery (Acute Pain Trial), improve chronic pain therapy (Chronic Pain Trial), or reduce depression symptoms more effectively than standard care (Depression Trial). Participants will be randomly assigned to immediate genetic-guided therapy or standard care with delayed testing.
What are the potential side effects?
Potential side effects aren't specified but may relate to the use of opioids like tramadol, hydrocodone, codeine in managing pain and SSRIs for treating depression. These can include nausea, drowsiness, constipation for opioids; and fatigue, sexual dysfunction and mood swings for SSRIs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 8 years old or older.
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I am 18 years old or older.
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I am currently experiencing severe pain.
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I am currently using or considering tramadol, hydrocodone, or codeine for pain.
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I have been diagnosed with depression.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
You are not expected to live more than a year, cannot understand the study or follow its instructions, are in a care facility or too sick to take part, had a specific type of stem cell or liver transplant, or have taken a gene test for this study before.
Select...
I am having laparoscopic surgery and have been on opioids for more than 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months post return of results (chronic pain and depression; 6 months post surgery for acute pain)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months post return of results (chronic pain and depression; 6 months post surgery for acute pain)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
All Trials Concordance between metabolizer phenotype and prescribed medication
All Trials Overall well-being, as measured by PROMIS 43 survey
All Trials Sub-domain of the PROMIS 43 survey: Pain interference
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Depression - Immediate PGx TestingExperimental Treatment2 Interventions
Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider
Group II: Depression - Delayed PGx TestingExperimental Treatment1 Intervention
Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period
Group III: Chronic Pain - Immediate PGx TestingExperimental Treatment2 Interventions
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Group IV: Chronic Pain - Delayed PGx TestingExperimental Treatment1 Intervention
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Group V: Acute Pain - Immediate PGx TestingExperimental Treatment2 Interventions
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Group VI: Acute Pain - Delayed PGx TestingExperimental Treatment1 Intervention
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,977,436 Total Patients Enrolled
76 Trials studying Depression
35,144 Patients Enrolled for Depression
Hrishikesh ChakrabortyPrincipal InvestigatorDuke University
4 Previous Clinical Trials
10,865 Total Patients Enrolled
1 Trials studying Depression
1,461 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 8 years old or older.I experience chronic pain.You are planning to move away in the next 6 months, currently receiving treatment for cancer, or regularly taking opioids other than tramadol, codeine, or hydrocodone.I am scheduled for surgery that will use tramadol, hydrocodone, or codeine for pain.You have been seen at a primary care clinic or a specialty clinic for pain-related issues.I am 18 or older, speak English or Spanish, have had pain for 3+ months, and am considering or on tramadol, hydrocodone, or codeine.I am 8 or older, speak English or Spanish, have depression, and am starting or changing SSRI therapy.You are not expected to live more than a year, cannot understand the study or follow its instructions, are in a care facility or too sick to take part, had a specific type of stem cell or liver transplant, or have taken a gene test for this study before.I have been diagnosed with depression.I am having laparoscopic surgery and have been on opioids for more than 3 months.I have had symptoms of depression for at least 3 months.I do not plan to move soon, and I do not have psychosis, dementia, cognitive disabilities, seizures, or bipolar disorder.I am over 8, speak English or Spanish, and will have surgery needing specific pain meds.I speak English or Spanish.I have been experiencing pain for at least the last 3 months.I am 18 years old or older.I am currently experiencing severe pain.I am currently using or considering tramadol, hydrocodone, or codeine for pain.I have been diagnosed with depression.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Depression - Immediate PGx Testing
- Group 2: Chronic Pain - Delayed PGx Testing
- Group 3: Chronic Pain - Immediate PGx Testing
- Group 4: Depression - Delayed PGx Testing
- Group 5: Acute Pain - Immediate PGx Testing
- Group 6: Acute Pain - Delayed PGx Testing
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04445792 — N/A