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Clinical Decision Support
Genotype-Guided Pain Management for Acute Pain (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
Undergoing a laparoscopic surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months post-surgery
Awards & highlights
ADOPT PGx Trial Summary
This trial studies whether testing & genotype-guided pain management improves pain after surgery for people whose bodies process some pain meds differently.
Who is the study for?
This trial is for English or Spanish speakers aged 8 years and older who are planning to have elective surgeries like orthopedic, abdominal, or cardiothoracic surgery and expect to manage pain with certain opioids. It's not for those on chronic opioid therapy, with a life expectancy under 12 months, cognitive impairments preventing consent, institutionalization, history of certain transplants, or prior relevant pharmacogenetic tests.Check my eligibility
What is being tested?
The Acute Pain Trial compares immediate pharmacogenetic testing and tailored post-surgery opioid therapy against standard care with delayed testing. The goal is to see if personalized pain management based on genetic testing can improve pain control in patients slow at processing some pain medicines.See study design
What are the potential side effects?
While the trial primarily focuses on effectiveness rather than side effects, potential risks may include issues related to the surgical procedure itself and reactions from genotype-guided opioid therapy which could range from mild discomfort to more serious medication-related complications.
ADOPT PGx Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 8 years old or older.
Select...
I am scheduled for a minimally invasive surgery.
ADOPT PGx Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 months post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
10 Day SIA Score Change from Baseline
Secondary outcome measures
1 Month Mobility Score Change from Baseline
10 Day Pain Intensity Change from Baseline
3 Month Prescription Pain Medication Misuse Change from Baseline
+2 moreADOPT PGx Trial Design
2Treatment groups
Experimental Treatment
Group I: 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 II: 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
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Who is running the clinical trial?
National Human Genome Research Institute (NHGRI)NIH
263 Previous Clinical Trials
282,530 Total Patients Enrolled
Duke UniversityLead Sponsor
2,360 Previous Clinical Trials
3,418,728 Total Patients Enrolled
9 Trials studying Acute Pain
6,800 Patients Enrolled for Acute Pain
Hrishikesh ChakrabortyPrincipal InvestigatorDuke University
4 Previous Clinical Trials
13,374 Total Patients Enrolled
1 Trials studying Acute Pain
4,111 Patients Enrolled for Acute Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for less than one year.I speak English or Spanish.I am unable to understand or follow the study's procedures due to cognitive issues.I am scheduled for a minimally invasive surgery.I have had a stem cell or liver transplant from a donor.I am not institutionalized, too ill, or incarcerated to participate.I have genetic test results for CYP2D6 or CYP2C19 relevant to pain or depression studies.I am 8 years old or older.I am scheduled for surgery that will use tramadol, hydrocodone, or codeine for pain.I have been taking opioids almost daily for more than 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Acute Pain - Immediate PGx Testing
- Group 2: Acute Pain - Delayed PGx Testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an opportunity for people to enlist in this research?
"According to clinicaltrials.gov, this medical trial is currently recruiting participants. It was originally posted on February 10th 2021 and has been revised as recently as July 21st 2023."
Answered by AI
How many individuals have agreed to participate in this clinical trial?
"This study calls for 2004 participants that satisfy the predetermined requirements. Those looking to enrol can do so through various clinical trial sites, including University of Florida - Gainesville in Gainesville, FL and Indiana University in Jacksonville, IN."
Answered by AI
Are there numerous venues in the city executing this research?
"University of Florida - Gainesville in Gainesville, Indiana University Jacksonville in Indianapolis and Icahn School of Medicine at Mount Sinai in Orlando, New york are all enrolling patients for this trial. Additionally there are 11 other sites that will be providing treatment to participants."
Answered by AI
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