DepressionADOPT PGxNCT04445792

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

A study testing Pharmacogenetic testing and Clinical decisions support in people with Depression and Acute Pain, run by Duke University at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 8 years and older
Conditions the study is for: Depression, Acute Pain, Chronic Pain
What is being tested?: Pharmacogenetic testing and Clinical decisions support
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,284 participants
Where: 14 sitesUnited States
Study dates: 24 Feb 2021to 10 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Show all 17Show fewer

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

Who cannot join

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

Show all 20Show fewer

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

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

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

Other trials in United States

About this study

Official title: A Depression and Opioid Pragmatic Trial in Pharmacogenetics

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.

Read the 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.

Conditions: Depression, Acute Pain, Chronic Pain
Being tested: Pharmacogenetic testing, Clinical decisions support
Keywords: Pharmacogenetic, CYP2D6, CYP2C19
Medical subject headings: Depression, Acute Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pharmacogenetic testingOther
Genetic testing of CYP2D6 and CYP2C19
Clinical decisions supportOther
Prescribing recommendations to the provider based on the pharmacogenetic testing results

Study groups in NCT04445792
Study group	Role	What they receive
Acute Pain - Immediate PGx Testing	Experimental	Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Pharmacogenetic testing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Up to 3 years

Secondary outcomes (9)

Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
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.
Measured: 6 months
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
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.
Measured: 6 months
Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
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.
Measured: 6 months
Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
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.
Measured: 6 months
Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
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.
Measured: 6 months
Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
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.
Measured: 6 months
Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
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.
Measured: 6 months
Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
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.
Measured: 6 months
Number of Participants With Pharmacogenetic Drug-Gene Concordance
Concordance between PGx phenotypes and opioid (Acute Pain and Chronic Pain) and SSRI (Depression) medications.
Measured: 10 days for Acute Pain; 3 months for Chronic Pain and Depression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 202110 May 2024

First posted24 Jun 2020
Study start24 Feb 2021
Primary completion6 Oct 2023
Study completion10 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy
Masking: None (open label)
Enrolment: 4,284 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04445792
Sponsor's protocol ID: PRO00104948
Acronym: ADOPT PGx
Status last verified: Mar 2026
First submitted: 22 Jun 2020
Last updated: 25 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35899435
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.
PubMed 38860639
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.
PubMed 39177194
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.
PubMed 41719044
Blake KV, Hines LJ, Liu M, Myers RA, Baye JF, Cavanaugh KL, Duong BQ, Hulvershorn LA, Mathews CA, Murrough JW, Orlando LA, Petry NJ, Tillman EM, Sadeghpour A, Voora D, Block SL, Cicali EJ, Clermont S, Elwood EN, Harris EC, Nguyen KA, Ramos MA, Rosenman MB, Shroff N, Shuman S, Wyatt C, Horowitz CR, Volpi S, Singh R, Rider RA, Chakraborty H, Dexter PR, Johnson JA, Skaar TC, Cavallari LH, Peterson JF; IGNITE Pragmatic Trials Network. Genotype-Guided Antidepressant Prescribing for Patients With Depression: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2610609. doi: 10.1001/jamanetworkopen.2026.10609.
PubMed 42090156

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Depression and Opioid Pragmatic Trial in Pharmacogenetics
ClinicalTrials.gov ID: NCT04445792
Acronym / sponsor ID: ADOPT PGx / PRO00104948
Conditions: Depression, Acute Pain, Chronic Pain
Keywords: Pharmacogenetic, CYP2D6, CYP2C19
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,284 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 24 Feb 2021 (actual)
Primary completion: 6 Oct 2023 (actual)
Study completion: 10 May 2024 (actual)
First posted: 24 Jun 2020 (actual)
Results: Posted 6 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.

Study objectives:

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
Model description: Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy

Arm	Type	Receives
Acute Pain - Immediate PGx Testing	Experimental	Other: Pharmacogenetic testing, Other: Clinical decisions supportImmediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Acute Pain - Delayed PGx Testing	Other	Other: Pharmacogenetic testingDelayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Chronic Pain - Immediate PGx Testing	Experimental	Other: Pharmacogenetic testing, Other: Clinical decisions supportImmediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Chronic Pain - Delayed PGx Testing	Other	Other: Pharmacogenetic testingDelayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Depression - Immediate PGx Testing	Experimental	Other: Pharmacogenetic testing, Other: Clinical decisions supportImmediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider
Depression - Delayed PGx Testing	Other	Other: Pharmacogenetic testingDelayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period

Who may qualify

Ages: 8 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (17 listed)

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

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pharmacogenetic testingGenetic testing of CYP2D6 and CYP2C19	Other	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 supportPrescribing recommendations to the provider based on the pharmacogenetic testing results	Other	Acute Pain - Immediate PGx Testing, Chronic Pain - Immediate PGx Testing, Depression - Immediate PGx Testing

Primary outcome

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.
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.
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.

9 secondary outcomes

Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: 6 months
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: 6 months
Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: 6 months
Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: 6 months
Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: 6 months
Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: 6 months
Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: 6 months
Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: 6 months
Number of Participants With Pharmacogenetic Drug-Gene Concordance
Time frame: 10 days for Acute Pain; 3 months for Chronic Pain and Depression

Results and safety

Results posted to the registry on 6 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acute Pain, Chronic Pain, and Depression Trial Participants	4,110	3,502

Primary outcome: Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record)

Time frame: Up to 3 years. Count of participants. Unit: Participants

Measure	Individuals Identified as Potential Participants Through EHR n = 77,451
Value	17,496

Population analysed: Individuals who were prescreened.

Primary outcome: Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials

Time frame: Up to 3 years. Count of participants. Unit: Participants

Measure	Acute Pain, Chronic Pain, and Depression Trial Participants n = 17,496
Value	4,285

Population analysed: Individuals who were screened for the Acute Pain, Chronic Pain, and Depression Trials.

Primary outcome: Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials

Time frame: Up to 3 years. Count of participants. Unit: Participants

Measure	Acute Pain, Chronic Pain, and Depression Trial Participants n = 4284
Value	4110

Population analysed: Participants who were consented to the Acute Pain, Chronic Pain, and Depression Trials.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Pharmacogenetics (PGx) Guided Therapy	0 of 2,550 (0%)	1 of 2,550 (0%)	5 of 2,055
Delayed Pharmacogenetics (PGx) Testing	0 of 2,550 (0%)	0 of 2,550 (0%)	7 of 2,055

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35899435Cavallari 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.
Background: PubMed 38860639Hines 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.
Background: PubMed 39177194Skaar 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.
Results publication: PubMed 41719044Cavallari 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.
Derived from this study: PubMed 42090156Blake KV, Hines LJ, Liu M, Myers RA, Baye JF, Cavanaugh KL, Duong BQ, Hulvershorn LA, Mathews CA, Murrough JW, Orlando LA, Petry NJ, Tillman EM, Sadeghpour A, Voora D, Block SL, Cicali EJ, Clermont S, Elwood EN, Harris EC, Nguyen KA, Ramos MA, Rosenman MB, Shroff N, Shuman S, Wyatt C, Horowitz CR, Volpi S, Singh R, Rider RA, Chakraborty H, Dexter PR, Johnson JA, Skaar TC, Cavallari LH, Peterson JF; IGNITE Pragmatic Trials Network. Genotype-Guided Antidepressant Prescribing for Patients With Depression: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2610609. doi: 10.1001/jamanetworkopen.2026.10609.
Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigatorsLink provided by the sponsor.
Rationale and design for a pragmatic randomized trial to assess gene-based prescribing for SSRIs in the treatment of depressionLink provided by the sponsor.
Implementing a pragmatic clinical trial to tailor opioids for chronic pain on behalf of the IGNITE ADOPT PGx InvestigatorsLink provided by the sponsor.
CYP2D6-Guided Opioid Management and Postoperative Pain Control: A Randomized Clinical TrialLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hrishikesh Chakraborty principal investigator

Duke University

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacogenetic testing and Clinical decisions support in people with Depression and Acute Pain, run by Duke University at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record) (time frame: Up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04445792, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.