Acute PainADOPT PGxNCT05966129
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)
A study testing Pharmacogenetic testing and Clinical decisions support in people with Acute Pain, run by Duke University at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Acute 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
- 1,602 participants
- Where
- 11 sitesUnited States
- Study dates
- 10 Mar 2021to 25 Mar 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 Trial
- 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
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 9Show fewer
- Acute Pain Trial
- Undergoing a laparoscopic surgery
- Receiving chronic opioid therapy, defined as use of opioids on most days for >3 months
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Duke University Medical Center
Durham, North Carolina, 27710
Sanford Health
Fargo, North Dakota, 58104
University of Florida - Gainesville
Gainesville, Florida, 32610
Indiana University
Indianapolis, Indiana, 46202
Nemours Children's Health System
Jacksonville, Florida, 32207
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
Nemours Children's Health System
Orlando, Florida, 32827
Nemours Children's Health System
Wilmington, Delaware, 19803
About this study
Official title: A Depression and Opioid Pragmatic Trial in Pharmacogenetics
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 Acute Pain Trial within the ADOPT-PGx protocol.
The Acute 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 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.
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:
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.
- Conditions
- Acute Pain
- Being tested
- Pharmacogenetic testing, Clinical decisions support
- Keywords
- Pharmacogenetic, CYP2D6, CYP2C19
- Medical subject headings
- Acute 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 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 Day Silverman Integrated Analgesic Assessment (SIA) Score
A composite measure of pain and opioid usage, the Silverman Integrated Analgesic Assessment (SIA) score, at 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75. The SIA has a total score range of -200 to 200, where a higher score corresponds with higher pain and opioid use.
Measured: Day of surgery (baseline) to 10 days post surgery
Secondary outcomes (6)
10 Day Pain Intensity as Measured by the PROMIS Numeric Pain Rating Scale
PROMIS (Patient-Reported Outcomes Measurement Information System) Numeric Pain Rating Scale Pain intensity at 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75. Pain was measured on a scale of 0-10, where higher scores correspond to higher levels of pain.
Measured: 10 days post-surgery
Post-surgery Opioid Usage, Measured in Milligrams of Morphine Equivalents (MME) Per Day
Opioid usage from surgery to 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Measured: Day of surgery (baseline) to 10 days post surgery
3 Month Prescription Pain Medication Misuse
The 7-item PROMIS Prescription Pain Medication Misuse questionnaire assesses the extent to which participants experience medication misuse symptoms over the past 3 months using a 5-point Likert scale. The 7 questions are converted to a raw score, ranging from 7 to 35. Raw scores are converted to T-scores using the PROMIS conversion tables and range from 36.3 to 55.8. Higher scores reflect greater medication misuse.
Measured: 3 months post surgery
1 Month PROMIS Mobility Score
PROMIS mobility score at 1 month post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75 in the adult population only. The score ranges from 15 to 75, where a higher score corresponds to higher mobility.
Measured: 1 month post surgery
Number of Participants With Opioid Persistence
Opioid persistence defined as a filled prescription for an opioid medication 3-6 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Measured: 3-6 months post-surgery, assessed at 6 months
Participants With Drug-Gene Concordance
Drug-Gene Concordance defined as an agreement between the Pharmacogenomics (PGx) Test and the prescribed opioids post surgery for pain management in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75
Measured: Within 10 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start10 Mar 2021
- Primary completion25 Mar 2024
- Study completion25 Mar 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 (2)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies 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
- 1,602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), University of Florida, Vanderbilt University Medical Center, Indiana University, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Hrishikesh Chakraborty, Study director, Duke UniversityLarisa H. Cavallari, PharmD, Principal investigator, University of FloridaJulie A. Johnson, PharmD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966129
- Sponsor's protocol ID
- PRO00104948_A
- Other IDs
- U01HG010225
- Acronym
- ADOPT PGx
- Status last verified
- Mar 2026
- First submitted
- 21 Jul 2023
- Last updated
- 19 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 35899435Cavallari 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
Study at a glance
From the registry record, last updated by the sponsor on 19 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
- NCT05966129
- Acronym / sponsor ID
- ADOPT PGx / PRO00104948_A
- Conditions
- Acute Pain
- Keywords
- Pharmacogenetic, CYP2D6, CYP2C19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,602 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), University of Florida, Vanderbilt University Medical Center, Indiana University, Icahn School of Medicine at Mount Sinai
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Acute Pain Trial within the ADOPT-PGx protocol.
The Acute 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 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.
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:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Acute Pain Trial
- 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
Key exclusion criteria (9 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 |
| Clinical decisions supportPrescribing recommendations to the provider based on the pharmacogenetic testing results | Other | Acute Pain - Immediate PGx Testing |
Primary outcome
10 Day Silverman Integrated Analgesic Assessment (SIA) Score
Time frame: Day of surgery (baseline) to 10 days post surgery
A composite measure of pain and opioid usage, the Silverman Integrated Analgesic Assessment (SIA) score, at 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75. The SIA has a total score range of -200 to 200, where a higher score corresponds with higher pain and opioid use.
6 secondary outcomes
10 Day Pain Intensity as Measured by the PROMIS Numeric Pain Rating Scale
Time frame: 10 days post-surgery
Post-surgery Opioid Usage, Measured in Milligrams of Morphine Equivalents (MME) Per Day
Time frame: Day of surgery (baseline) to 10 days post surgery
3 Month Prescription Pain Medication Misuse
Time frame: 3 months post surgery
1 Month PROMIS Mobility Score
Time frame: 1 month post surgery
Number of Participants With Opioid Persistence
Time frame: 3-6 months post-surgery, assessed at 6 months
Participants With Drug-Gene Concordance
Time frame: Within 10 days post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
- 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.
- Implementing a pragmatic clinical trial to tailor opioids for acute 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 study director
Duke University
Larisa H. Cavallari, PharmD principal investigator
University of Florida
Julie A. Johnson, PharmD principal investigator
Ohio State University
11 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 Acute Pain, run by Duke University at 11 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 4 inclusion and 9 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 19 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 11 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 5 Jun 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?
10 Day Silverman Integrated Analgesic Assessment (SIA) Score (time frame: Day of surgery (baseline) to 10 days post surgery). 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 NCT05966129, which also lists 2 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 19 Mar 2026.