Chronic PainADOPT PGxNCT05966142
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial)
A study testing Pharmacogenetic testing and Clinical decisions support in people with Chronic Pain, run by Duke University at 10 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 18 years and older
- Conditions the study is for
- 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
- 1,048 participants
- Where
- 10 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Pain Trial
- Age ≥ 18 years
- English speaking or Spanish speaking
- Seen at primary care clinics (such as, but not limited to, Internal Medicine, Family Medicine or Pediatrics) or patients seen in pain-relevant specialty clinics
- History of pain for at least the last 3 months
- Currently treated or being considered for treatment with tramadol, hydrocodone, or codeine to improve pain management
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 10Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida - Gainesville
Gainesville, Florida, 32610
Eskenazi Health
Indianapolis, Indiana, 46202
Indiana University
Indianapolis, Indiana, 46202
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
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 Chronic Pain Trial within the ADOPT-PGx protocol.
The Chronic Pain Trial is a prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal.
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 pain therapy in participants with at least 3 months of chronic pain leads to improved pain control compared to usual care.
- Conditions
- Chronic Pain
- Being tested
- Pharmacogenetic testing, Clinical decisions support
- Keywords
- Pharmacogenetic, CYP2D6, CYP2C19
- Medical subject headings
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
The composite pain intensity score is derived from the 3-time PROMIS (Patient-Reported Outcomes Measurement Information System) pain intensity scale. Composite pain intensity score is the sum of the 3 questions and ranges from 3 (no pain) to 15 (intense pain). Change in composite pain intensity score ranges from -12 (change from the highest level of pain to the lowest level of pain) to 12 (change from the lowest level of pain to the highest level of pain).
Measured: Baseline to 3 months
Secondary outcomes (4)
Pain Reduction Magnitude
Ratio of Composite Pain Score at 3 months relative to baseline. Composite pain intensity scores were shifted to range 0-12 and the pain reduction magnitude is reported as the ratio of pain at 3 months relative to pain at baseline using this adjusted scale. Statistical analyses were conducted using the log ratio pain at 3 months relative to pain at baseline. Due to the presence of 0 values in the ratios, the log ratios include a +.5 offset, i.e. log(3-month pain +.5 / baseline pain + 0.5).
Measured: Baseline to 3 months
Number of Participants With Clinically Significant Pain Reduction
Clinically significant pain reduction defined as ratio of 3-month composite pain score relative to baseline is < 0.7, corresponding to a 30% or more improvement in pain scores.
Measured: Baseline to 3 months
Prescription Pain Medication Misuse as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The 7-item PROMIS questionnaire assesses the extent to which participant experience prescription pain medication misuse symptoms in the past 3 months using a 5-point Likert scale. Participants are asked if they have had a prescription for pain medication in the last 3 months. If no, the questionnaire is not administered, if yes, the questionnaire is administered. For the completed questionnaires. Raw scores ranging from 7 to 35. Raw scores are converted to T-scores using the PROMIS conversion table, with T-scores ranging 36.3 to 54.1. Higher T-scores reflect greater symptom severity.
Measured: 3 months
Number of Participants With Drug-Gene Concordance
Concordance between the participant reported opioid medications at 3 months and CYP2D6 phenotype.
Measured: 3 months
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 start24 Feb 2021
- Primary completion10 May 2024
- 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 (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- 1,048 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 UniversityTodd Skaar, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966142
- Sponsor's protocol ID
- PRO00104948_B
- Other IDs
- U01HG010225
- Acronym
- ADOPT PGx
- Status last verified
- May 2025
- First submitted
- 21 Jul 2023
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. 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
- NCT05966142
- Acronym / sponsor ID
- ADOPT PGx / PRO00104948_B
- Conditions
- Chronic Pain
- Keywords
- Pharmacogenetic, CYP2D6, CYP2C19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,048 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
- 24 Feb 2021 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Posted 28 May 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 Chronic Pain Trial within the ADOPT-PGx protocol.
The Chronic Pain Trial is a prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal.
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 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
- 2
- Model description
- Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic Pain Trial
- Age ≥ 18 years
- English speaking or Spanish speaking
- Seen at primary care clinics (such as, but not limited to, Internal Medicine, Family Medicine or Pediatrics) or patients seen in pain-relevant specialty clinics
- History of pain for at least the last 3 months
Key exclusion criteria (10 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 | Chronic Pain - Delayed PGx Testing, Chronic Pain - Immediate PGx Testing |
| Clinical decisions supportPrescribing recommendations to the provider based on the pharmacogenetic testing results | Other | Chronic Pain - Immediate PGx Testing |
Primary outcome
Change in Pain Intensity
Time frame: Baseline to 3 months
The composite pain intensity score is derived from the 3-time PROMIS (Patient-Reported Outcomes Measurement Information System) pain intensity scale. Composite pain intensity score is the sum of the 3 questions and ranges from 3 (no pain) to 15 (intense pain). Change in composite pain intensity score ranges from -12 (change from the highest level of pain to the lowest level of pain) to 12 (change from the lowest level of pain to the highest level of pain).
4 secondary outcomes
Pain Reduction Magnitude
Time frame: Baseline to 3 months
Number of Participants With Clinically Significant Pain Reduction
Time frame: Baseline to 3 months
Prescription Pain Medication Misuse as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: 3 months
Number of Participants With Drug-Gene Concordance
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Implementing a pragmatic clinical trial to tailor opioids for chronic pain on behalf of the IGNITE ADOPT PGx investigatorsLink 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
Todd Skaar, PhD principal investigator
Indiana University
10 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 Chronic Pain, run by Duke University at 10 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 6 inclusion and 10 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 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 28 May 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?
Change in Pain Intensity (time frame: Baseline to 3 months). 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 NCT05966142, which also lists 1 linked publication.
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 28 May 2025.