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

March 6, 2026 updated by: Duke University

A Depression and Opioid Pragmatic Trial in Pharmacogenetics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pain and depression are conditions that impact substantial proportions of the US population. Finding safe and effective drug therapies for both conditions is challenging. In the case of treatment for acute and chronic pain, the challenge is finding effective therapy while minimizing adverse effects or opioid addiction (and the ensuing consequences). For depression, there are few clinically relevant predictors of successful treatment leading to multiple trials of inadequate therapy for some patients. Both opioid and antidepressant prescriptions can be guided by pharmacogenetics (PGx) data based on existing guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC).

This study is designed to evaluate the impact of pharmacogenetic testing and genotype-guided pain or anti-depressant therapy on pain control or depression symptoms in a pragmatic setting.

The rationale for examining a genotype-guided approach to acute and chronic pain management is based on the importance of CYP2D6 for the bioactivation of tramadol, codeine, and hydrocodone and data from a pilot study supporting improved pain control in intermediate and poor CYP2D6 metabolizers in the genotype-guided arm who are taking these drugs at baseline. Similarly, the rationale for examining a genotype-guided approach to depression medication therapy is based on the demonstrated role of CYP2D6 in the bio inactivation and CYP2C19 oxidation of select, commonly used SSRIs. Secondly, data from industry sponsored trials support the hypothesis of improved depression symptom control in a genotype-guided arm.

Study objectives:

Acute Pain Trial: Determine if a genotype-guided approach to acute post-surgical pain therapy leads to improved pain control compared to usual care, as defined by a decrease in the SIA score. Secondarily, The investigators will evaluate whether this approach leads to reduced use of DEA Schedule II opioids and reduced pain intensity.

Chronic Pain Trial: Determine if a genotype-guided approach to pain therapy in participants with at least 3 months of chronic pain leads to improved pain control compared to usual care.

Depression Trial: Determine if genotype-guided dosing or selection of antidepressants among participants with at least 3 months of depressive symptoms who require new or revised antidepressant therapy leads to improved control of depression, compared to usual care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4284

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours Children's Health System
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida - Gainesville
      • Jacksonville, Florida, United States, 32209
        • University of Florida - Jacksonville
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Health System
      • Orlando, Florida, United States, 32827
        • Nemours Children's Health System
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
      • Indianapolis, Indiana, United States, 46202
        • Eskenazi Health
    • New York
      • New York, New York, United States, 10029
        • ICAHN School of Medicine at Mount Sinai
      • New York, New York, United States, 10035
        • The Institute for Family Health
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Sanford Health
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College
      • Nashville, Tennessee, United States, 37208
        • Nashville General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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
  • Evidence of depressive symptoms for at least 3 months based on patient interview or documentation in electronic health records
  • Recent initiation of SSRI therapy, recent revised SSRI therapy, or anticipated need for revised or new SSRI therapy per health care provider

Exclusion Criteria

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
  • Have active psychosis or diagnosed psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, psychotic depression, substance induced psychosis, schizophreniform disorder)
  • Have dementia or other neurocognitive disorders due to any cause, such as Alzheimer's disease, vascular/subcortical, lewy body disease, frontotemporal lobar degeneration
  • Have cognitive developmental delay and/or cognitive disability, including autism spectrum disorders (Note: ADHD is not an exclusion criteria)
  • Has a seizure disorder
  • Have bipolar disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acute Pain - Immediate PGx Testing
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Other: Pharmacogenetic testing
Genetic testing of CYP2D6 and CYP2C19
Other: Clinical decisions support
Prescribing recommendations to the provider based on the pharmacogenetic testing results
Other: Acute Pain - Delayed PGx Testing
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Other: Pharmacogenetic testing
Genetic testing of CYP2D6 and CYP2C19
Experimental: Chronic Pain - Immediate PGx Testing
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Other: Pharmacogenetic testing
Genetic testing of CYP2D6 and CYP2C19
Other: Clinical decisions support
Prescribing recommendations to the provider based on the pharmacogenetic testing results
Other: Chronic Pain - Delayed PGx Testing
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Other: Pharmacogenetic testing
Genetic testing of CYP2D6 and CYP2C19
Experimental: Depression - Immediate PGx Testing
Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider
Other: Pharmacogenetic testing
Genetic testing of CYP2D6 and CYP2C19
Other: Clinical decisions support
Prescribing recommendations to the provider based on the pharmacogenetic testing results
Other: Depression - Delayed PGx Testing
Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period
Other: Pharmacogenetic testing
Genetic testing of CYP2D6 and CYP2C19

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record)
Time Frame: Up to 3 years
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
Time Frame: Up to 3 years
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
Time Frame: Up to 3 years
Individuals who were randomized to be in the Acute Pain, Chronic Pain and Depression Trials.
Up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time Frame: 6 months
The 6-item PROMIS 43 subscale for pain interference assesses the extent to which participants experience interference with daily activities over the past 7 days using a 5-point Likert scale. The pain interference subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 41.1 to 76.3. Higher scores reflect greater pain interference.
6 months
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time Frame: 6 months
The 6-item PROMIS 43 subscale for physical functioning assesses a participants physical functioning over the past 7 days using a 5-point Likert scale. The physical functioning sub scale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables. T-scores range from 21.0 to 59.0. Higher T-scores reflect higher levels of physical functioning.
6 months
Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time Frame: 6 months
The 6-item PROMIS 43 subscale for sleep disturbance assesses the extent to which participants experience sleep disturbance related symptoms sleep over the past 7 days using a 5-point Likert scale. The sleep disturbance subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMNIS conversion tables, ranging from 31.7 to 76.1. Higher scores reflect higher levels of sleep disturbance.
6 months
Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time Frame: 6 months
The 6-item PROMIS 43 subscale for ability to participate in social roles and activities assesses the extent to which participants are able to participant in different social roles and activities over the past 7 days using a 5-point Likert scale. The ability to participant in social roles and activities subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 26.7 to 65.0 with higher values corresponding to a higher ability to participant in social roles and activities.
6 months
Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time Frame: 6 months
The 6-item PROMIS 43 subscale for fatigue assesses the extent to which participants experience fatigue-related symptoms over the past 7 days using a 5-point Likert scale. The fatigue subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater fatigue symptoms.
6 months
Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time Frame: 6 months
The 6-item PROMIS subscale for anxiety assesses the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale. The anxiety subscale provides a raw score, ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater anxiety.
6 months
Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time Frame: 6 months
The 6-item PROMIS 43 subscale for depression assesses the extent to which participants experience depressive symptoms over the past 7 days using a 5-point Likert scale. The depression subscale provides a raw sore ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 38.4 to 80.3. Higher T-scores reflect greater depression.
6 months
Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time Frame: 6 months
Overall wellbeing is the sum of the PROMIS 43 subdomain T-scores, with physical function and ability to participate in social roles scores reversed such that higher values within each subscale correspond with poorer health. Overall wellbeing ranges from 259.7 to 541.2, higher scores correspond to worse wellbeing.
6 months
Number of Participants With Pharmacogenetic Drug-Gene Concordance
Time Frame: 10 days for Acute Pain; 3 months for Chronic Pain and Depression
Concordance between PGx phenotypes and opioid (Acute Pain and Chronic Pain) and SSRI (Depression) medications.
10 days for Acute Pain; 3 months for Chronic Pain and Depression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hrishikesh Chakraborty, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO00104948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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