ADOPT PGx is a study aiming to find safe and effective drug therapies for pain and depression. It includes three trials – Acute Pain, Chronic Pain, and Depression – grouped under one protocol due to similarities in intervention, hypotheses, and trial design.

ADOPT PGx White Logo [Small 3]

Study Overview

Status
Completed

Timeline
February 2021 – May 2024

Design
All three arms are designed as prospective, multicenter, two-arm randomized pragmatic trials to evaluate the impact of pharmacogenetic testing and genotype-guided pain or antidepressant therapy on pain control or depression symptoms.

Intervention / Treatment
Pharmacogenetic Testing

Sponsor
National Human Genome Research Institute (NHGRI)

QUICK LINKS

ACUTE PAIN

To assess whether using genotype-guided therapy for acute pain after surgery improves pain control compared to standard care, measured by a reduction in pain scores using the Silverman Integrated Approach (SIA). For more information about the acute pain trial, visit the ClinicalTrials.gov page: Acute Pain Trial.

PARTICIPATION CRITERIA

  • At least 8 years of age or older
  • English or Spanish speaking
  • Planned or anticipated treatment with tramadol, hydrocodone, or codeine for pain relief after an elective surgery type at an enrolling site (i.e. orthopedic surgeries, open abdominal surgery, cardiothoracic surgery, etc.)

PRINCIPAL INVESTIGATORS

  • Larisa Cavallari, PharmD
    Dean and Distinguished Professor
    College of Pharmacy
    University of Florida

 

  • Julie Johnson, PharmD
    Professor of Medicine and Pharmacy
    Director, Clinical and Translational Science Institute
    Associate Dean, Clinical and Translational Science
    Associate Vice President for Research
    The Ohio State University

CHRONIC PAIN

To assess using genotype-guided pain therapy in individuals with at least three months of chronic pain improves pain control compared to standard care.
For more information about the chronic pain trial, visit the ClinicalTrials.gov page: Chronic Pain Trial.

PARTICIPATION CRITERIA

  • At least 18 years of age or older
  • English or Spanish speaking
  • History of pain for at least 3 months
  • Seen at primary care or pain-relevant specialty clinics
  • Currently treated or being considered for treatment with tramadol, hydrocodone, or codeine for pain relief

PRINCIPAL INVESTIGATORS

  • Todd Skaar, PhD
    Professor of Medicine
    Division of Clinical Pharmacology
    Indiana University School of Medicine

 

  • Paul Dexter, MD
    Associate Professor of Clinical Medicine
    Division of General Internal Medicine
    Indiana University School of Medicine

DEPRESSION

To assess using genetic guidance to dose or select antidepressants in individuals with at least three months of depressive symptoms, who need new or adjusted antidepressant therapy, improves depression management compared to standard care. For more information about the depression trial, visit the ClinicalTrials.gov page: Depression Trial.

PARTICIPATION CRITERIA

  • At least 8 years of age or older
  • English or Spanish speaking
  • Patients followed at psychiatry or primary care clinics at an enrolling site
  • Documentation of depression and/or provider report of depression
  • Evidence of depressive symptoms for at least 3 months based on patient interview or documentation in patient's medical records
  • Recent initiation of SSRI therapy, revised SSRI therapy, or anticipated need for revised or new SSRI therapy per healthcare provider

PRINICIPAL INVESTIGATORS

  • Josh F. Peterson, MD, MPH
    Professor of Biomedical Informatics and Medicine
    Vanderbilt University

 

  • Kerri L. Cavanaugh, MD, MHS
    Associate Professor of Medicine
    Division of Nephrology and Hypertension
    Vanderbilt University