A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)

Summary

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.

Conditions

• Acute Pain

Interventions

OTHER

Pharmacogenetic testing

Genetic testing of CYP2D6 and CYP2C19

OTHER

Clinical decisions support

Prescribing recommendations to the provider based on the pharmacogenetic testing results

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI)

  collaborator NIH

• University of Florida

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• Indiana University School of Medicine

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Hrishikesh Chakraborty · Duke University

• Larisa H. Cavallari, PharmD · University of Florida

• Julie A. Johnson, PharmD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-10

Primary Completion

2024-03-25

Completion

2024-03-25

Countries

• United States

Study Locations