Genotype-Guided Pain Management for Acute Pain
(ADOPT PGx Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byHrishikesh Chakraborty

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design. The three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial. Participants can enroll in only one of the three trials. All three trials were registered on ClinicalTrials.gov under NCT04445792. In July 2023 each of the three treatment trials was registered under a separate NCT# and NCT04445792 was converted to a screening record per recent guidance on master protocol research programs (MPRPs). This record is specific to the Acute Pain Trial within the ADOPT-PGx protocol. The Acute Pain Trial is a prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm) or standard care and pharmacogenetic testing after 6 months (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain management therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal.

Eligibility Criteria

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.

Inclusion Criteria

I speak English or Spanish.

I am scheduled for a minimally invasive surgery.

I am 8 years old or older.

+1 more

Exclusion Criteria

You are expected to live for less than one year.

I am unable to understand or follow the study's procedures due to cognitive issues.

I have had a stem cell or liver transplant from a donor.

+3 more

Participant Groups

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.

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