A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center)

NCT04445792 | Completed Results DMC

• 1 other identifier: PRO00104948
• Study Type: interventional
• Target: 4,284
• Locations: 1 country
• Sites: 14

Brief Summary

This is a Master Protocol Screening record. 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. Each trial is listed individually on clinicaltrials.gov and includes "PRO00104948" within the Unique Protocol ID: PRO00104948\_A - Acute Pain Trial - NCT05966129 PRO00104948\_B - Chronic Pain Trial - NCT05966142 PRO00104948\_C - Depression Trial - NCT05966155 Acute Pain Trial: 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. Chronic Pain Trial: 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. Depression: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided anti-depressant 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 anti-depressant therapy will reduce depression symptoms in participants who's body processes some anti-depressants faster or slower than normal.

Conditions

Depression; Acute Pain; Chronic Pain

Keywords

Pharmacogenetic; CYP2D6; CYP2C19

Outcome Measures

Primary Outcomes (3)

• Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record)

  Potential participants identified for the Acute Pain, Chronic Pain, and Depression Trials through EHR.

  Up to 3 years

• Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials

  Individuals who were screened to be in the Acute Pain, Chronic Pain and Depression Trials.

  Up to 3 years

• Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials

  Individuals who were randomized to be in the Acute Pain, Chronic Pain and Depression Trials.

  Up to 3 years

Secondary Outcomes (9)

• Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

  6 months

• Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

  6 months

• Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

  6 months

• Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

  6 months

• Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

  6 months

Study Arms (6)

Acute 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

Acute 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

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

Depression - Immediate PGx Testing

EXPERIMENTAL

Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider

Other: Pharmacogenetic testing; Other: Clinical decisions support

Depression - Delayed PGx Testing

OTHER

Delayed genetic testing of CYP2D6 and CYP2C19 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

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

Clinical decisions support OTHER

Prescribing recommendations to the provider based on the pharmacogenetic testing results

Acute Pain - Immediate PGx Testing; Chronic Pain - Immediate PGx Testing; Depression - Immediate PGx Testing

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute Pain
• Age ≥ 8 years
• English speaking or Spanish speaking
• Elective/planned surgery types with planned or anticipated to be treated with tramadol, hydrocodone, or codeine pain management at an enrolling site, which may include orthopedic surgeries (e.g. arthroplasty, spine, etc.), open abdominal surgery, or cardiothoracic surgery and others
• Chronic Pain
• 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
• Depression
• Age ≥ 8 years
• English speaking or Spanish speaking
• Patients followed at psychiatry clinics or primary care clinics at an enrolling site (such as, but not limited to, Internal Medicine, Family Medicine, or Pediatrics)
• Documentation of depression and/or provider report of depression

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
• Acute Pain
• Undergoing a laparoscopic surgery
• Receiving chronic opioid therapy, defined as use of opioids on most days for \>3 months
• 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
• Depression
• Plan to move out of the area within 6 months of enrollment

Sponsors & Collaborators

• Duke University: lead

Study Sites (14)

Nemours Children's Health System

Wilmington, Delaware, 19803, United States

Location

University of Florida - Gainesville

Gainesville, Florida, 32610, United States

Location

Nemours Children's Health System

Jacksonville, Florida, 32207, United States

Location

University of Florida - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Nemours Children's Health System

Orlando, Florida, 32827, 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

Sanford Health

Fargo, North Dakota, 58104, 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 (4)

• Cavallari LH, Cicali E, Wiisanen K, Fillingim RB, Chakraborty H, Myers RA, Blake KV, Asiyanbola B, Baye JF, Bronson WH, Cook KJ, Elwood EN, Gray CF, Gong Y, Hines L, Kannry J, Kucher N, Lynch S, Nguyen KA, Obeng AO, Pratt VM, Prieto HA, Ramos M, Sadeghpour A, Singh R, Rosenman M, Starostik P, Thomas CD, Tillman E, Dexter PR, Horowitz CR, Orlando LA, Peterson JF, Skaar TC, Van Driest SL, Volpi S, Voora D, Parvataneni HK, Johnson JA; IGNITE Pragmatic Trials Network. Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators. Clin Transl Sci. 2022 Oct;15(10):2479-2492. doi: 10.1111/cts.13376. Epub 2022 Aug 4.

  PMID: 35899435 BACKGROUND

• Hines LJ, Wilke RA, Myers R, Mathews CA, Liu M, Baye JF, Petry N, Cicali EJ, Duong BQ, Elwood E, Hulvershorn L, Nguyen K, Ramos M, Sadeghpour A, Wu RR, Williamson L, Wiisanen K, Voora D, Singh R, Blake KV, Murrough JW, Volpi S, Ginsburg GS, Horowitz CR, Orlando L, Chakraborty H, Dexter P, Johnson JA, Skaar TC, Cavallari LH, Van Driest SL, Peterson JF; IGNITE Pragmatic Trials Network. Rationale and design for a pragmatic randomized trial to assess gene-based prescribing for SSRIs in the treatment of depression. Clin Transl Sci. 2024 Jun;17(6):e13822. doi: 10.1111/cts.13822.

  PMID: 38860639 BACKGROUND

• 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

• Cavallari LH, Myers RA, Chakraborty H, Skaar TC, Gray CF, Baye JF, Volpi S, Rider R, Cicali EJ, Elwood EN, Harris EC, Hines LJ, Nahid NA, Nguyen KA, Obeng AO, Parr JA, Ramos MA, Orlando LA, Prieto HA, Sadeghpour A, Singh R, Starostik P, Tillman EM, Wyatt C, Horowitz CR, Voora D, Blake KV, Parvataneni HK, Fillingim RB, Dexter PR, Peterson JF, Johnson JA; IGNITE Pragmatic Trials Network. CYP2D6-Guided Opioid Management and Postoperative Pain Control: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2558299. doi: 10.1001/jamanetworkopen.2025.58299.

  PMID: 41719044 RESULT

Related Links

• Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators
• Rationale and design for a pragmatic randomized trial to assess gene-based prescribing for SSRIs in the treatment of depression
• Implementing a pragmatic clinical trial to tailor opioids for chronic pain on behalf of the IGNITE ADOPT PGx Investigators
• CYP2D6-Guided Opioid Management and Postoperative Pain Control: A Randomized Clinical Trial

MeSH Terms

Conditions

Depression; Acute Pain; Chronic Pain

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; 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: Kady-Ann Steen-Burrell, Ph.D.
• Organization: Duke Clinical Research Institute

kady.ann.steen.burrell@duke.edu

919-668-8300

Study Officials

• Hrishikesh Chakraborty

  Duke 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: June 22, 2020
• First Posted: June 24, 2020
• Study Start: February 24, 2021
• Primary Completion: October 6, 2023
• Study Completion: May 10, 2024
• Last Updated: March 25, 2026
• Results First Posted: January 6, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)