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

NCT05966142 | Completed Results DMC

• 2 other identifiers: PRO00104948_BU01HG010225
• Study Type: interventional
• Target: 1,048
• Locations: 1 country
• Sites: 10

Brief 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 Chronic Pain Trial within the ADOPT-PGx protocol. The Chronic 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 opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal.

Conditions

Chronic Pain

Keywords

Pharmacogenetic; CYP2D6; CYP2C19

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  The composite pain intensity score is derived from the 3-time PROMIS (Patient-Reported Outcomes Measurement Information System) pain intensity scale. Composite pain intensity score is the sum of the 3 questions and ranges from 3 (no pain) to 15 (intense pain). Change in composite pain intensity score ranges from -12 (change from the highest level of pain to the lowest level of pain) to 12 (change from the lowest level of pain to the highest level of pain).

  Baseline to 3 months

Secondary Outcomes (4)

• Pain Reduction Magnitude

  Baseline to 3 months

• Number of Participants With Clinically Significant Pain Reduction

  Baseline to 3 months

• Prescription Pain Medication Misuse as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

  3 months

• Number of Participants With Drug-Gene Concordance

  3 months

Study Arms (2)

Chronic Pain - Immediate PGx Testing

EXPERIMENTAL

Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider

Other: Pharmacogenetic testing; Other: Clinical decisions support

Chronic Pain - Delayed PGx Testing

OTHER

Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period

Other: Pharmacogenetic testing

Interventions

Pharmacogenetic testing OTHER

Genetic testing of CYP2D6 and CYP2C19

Chronic Pain - Delayed PGx Testing; Chronic Pain - Immediate PGx Testing

Clinical decisions support OTHER

Prescribing recommendations to the provider based on the pharmacogenetic testing results

Chronic Pain - Immediate PGx Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Pain Trial
• Age ≥ 18 years
• English speaking or Spanish speaking
• Seen at primary care clinics (such as, but not limited to, Internal Medicine, Family Medicine or Pediatrics) or patients seen in pain-relevant specialty clinics
• History of pain for at least the last 3 months
• Currently treated or being considered for treatment with tramadol, hydrocodone, or codeine to improve pain management

You may not qualify if:

• 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 (i.e. mental or nursing home facility or incarcerated)
• 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 (CYP2D6 for the pain studies and CYP2D6 or CYP2C19 for depression) or already enrolled in an ADOPT PGx trial
• Chronic Pain
• Plan to move out of the area within 6 months of enrollment
• Undergoing treatment for an active cancer diagnosis
• Currently taking daily opioids other than tramadol, codeine or hydrocodone

Sponsors & Collaborators

• Duke University: lead
• National Human Genome Research Institute (NHGRI): collaborator
• University of Florida: collaborator
• Vanderbilt University Medical Center: collaborator
• Indiana University School of Medicine: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (10)

University of Florida - Gainesville

Gainesville, Florida, 32610, United States

Location

University of Florida - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Institute for Family Health

New York, New York, 10035, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Nashville General Hospital

Nashville, Tennessee, 37208, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Skaar TC, Myers RA, Fillingim RB, Callaghan JT, Cicali E, Eadon MT, Elwood EN, Ginsburg GS, Lynch S, Nguyen KA, Obeng AO, Park H, Pratt VM, Rosenman M, Sadeghpour A, Shuman S, Singh R, Tillman EM, Volpi S, Wiisanen K, Winterstein AG, Horowitz CR, Voora D, Orlando L, Chakraborty H, Van Driest S, Peterson JF, Cavallari LA, Johnson JA, Dexter PR; IGNITE Pragmatic Trials Network. Implementing a pragmatic clinical trial to tailor opioids for chronic pain on behalf of the IGNITE ADOPT PGx investigators. Clin Transl Sci. 2024 Aug;17(8):e70005. doi: 10.1111/cts.70005.

  PMID: 39177194 BACKGROUND

Related Links

• Implementing a pragmatic clinical trial to tailor opioids for chronic pain on behalf of the IGNITE ADOPT PGx investigators

MeSH Terms

Conditions

Chronic Pain

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Hrishikesh Chakraborty, PhD
• Organization: Duke University

hrishikesh.chakraborty@duke.edu

919-668-1238

Study Officials

• Hrishikesh Chakraborty

  Duke University

  STUDY DIRECTOR

• Todd Skaar, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: February 24, 2021
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)