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

Primary Purpose

Depression, Acute Pain, Chronic Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacogenetic testing
Clinical decisions support
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Pharmacogenetic, CYP2D6, CYP2C19

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nemours Children's Health System
  • University of Florida - Gainesville
  • Nemours Children's Health System
  • University of Florida - Jacksonville
  • Nemours Children's Health System
  • Eskenazi Health
  • Indiana University
  • Icahn School of Medicine at Mount Sinai
  • The Institute for Family Health
  • Duke University Medical Center
  • Sanford Health
  • Meharry Medical College
  • Nashville General Hospital
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Other

Experimental

Other

Experimental

Other

Arm Label

Acute Pain - Immediate PGx Testing

Acute Pain - Delayed PGx Testing

Chronic Pain - Immediate PGx Testing

Chronic Pain - Delayed PGx Testing

Depression - Immediate PGx Testing

Depression - Delayed PGx Testing

Arm Description

Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider

Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period

Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider

Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period

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

Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period

Outcomes

Primary Outcome Measures

Acute Pain - 10 Day SIA Score Change from Baseline
Acute Pain: 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.
Chronic Pain -3 Month Pain Control Change from Baseline
Chronic Pain: Pain control, defined as change in the composite pain intensity score from baseline to 3-months in participants who have genotypic or pheno-converted CYP2D6 activity score ≤ 0.75. The composite pain intensity score is derived from the PROMIS pain intensity scale
Depression - 3 Month Depression Symptom Control Change from Baseline
Depression symptom control, defined as change in PROMIS depression T-scores from baseline to 3-months in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers

Secondary Outcome Measures

Acute Pain -10 Day Pain Intensity Change from Baseline
PROMIS 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.
Acute Pain Trial - Post-surgery Opioid Usage Change from Baseline
Opioid usage from surgery to10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Acute Pain Trial - 3 Month Prescription Pain Medication Misuse Change from Baseline
PROMIS prescription pain medication misuse T-scores at 3 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Acute Pain - 1 Month Mobility Score Change from Baseline
PROMIS mobility score at 1 month post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Acute Pain - Opioid Persistence Change from Baseline
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
Chronic Pain - 3 Month Pain Reduction Change from Baseline
Pain reduction is defined as the ratio of the 3 month and baseline composite pain scores in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Chronic Pain - 3 Month Clinically Significant Pain Reduction Change from Baseline
PROMIS prescription pain medication misuse T-scores at 3 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75
Chronic Pain -3 Month Prescription Pain Medication Misuse Change from Baseline
PROMIS prescription pain medication misuse T-scores at 3 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75
Depression - 3 Month Change in PHQ of Depression Symptomatology Change from Baseline Scores
Change in PHQ-8 scores between baseline and 3 months in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers. Achieve 50% reduction in scores.
Depression - 3 Month Medication Side Effect Burden Change from Baseline
Side effect burden is defined as the number of side effects experienced from a specified list of possible side effects, weighted by the severity of each side effect in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers
Depression - 3 Month Medication Adherence Change from Baseline
Medication adherence score derived from the Voils Medication Adherence survey in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers
Depression - 6 Month Depression Remission Change from Baseline
Remission is defined as whether or not the summed raw responses to the PROMIS emotional distress depression survey is ≤ 16, corresponding to a participant respond "rarely" or "never" to most or all questions.
All Trials Overall well-being, as measured by PROMIS 43 survey
Overall well-being
All Trials Concordance between metabolizer phenotype and prescribed medication
Concordance between metabolizer phenotype and prescribed medication
All Trials Sub-domain of the PROMIS 43 survey: Pain interference
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
All Trials Sub-domain of the PROMIS 43 survey: physical function
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
All Trials Sub-domain of the PROMIS 43 survey: sleep disturbance
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
All Trials Sub-domain of the PROMIS 43 survey: social role and activities functioning
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
All Trials Sub-domain of the PROMIS 43 survey: fatigue
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
All Trials Sub-domain of the PROMIS 43 survey: anxiety
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
All Trials Sub-domain of the PROMIS 43 survey: depression
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do

Full Information

First Posted
June 22, 2020
Last Updated
October 23, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04445792
Brief Title
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center)
Acronym
ADOPT PGx
Official Title
A Depression and Opioid Pragmatic Trial in Pharmacogenetics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Acute Pain, Chronic Pain
Keywords
Pharmacogenetic, CYP2D6, CYP2C19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute Pain - Immediate PGx Testing
Arm Type
Experimental
Arm Description
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Arm Title
Acute Pain - Delayed PGx Testing
Arm Type
Other
Arm Description
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Arm Title
Chronic Pain - Immediate PGx Testing
Arm Type
Experimental
Arm Description
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Arm Title
Chronic Pain - Delayed PGx Testing
Arm Type
Other
Arm Description
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Arm Title
Depression - Immediate PGx Testing
Arm Type
Experimental
Arm Description
Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider
Arm Title
Depression - Delayed PGx Testing
Arm Type
Other
Arm Description
Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period
Intervention Type
Other
Intervention Name(s)
Pharmacogenetic testing
Intervention Description
Genetic testing of CYP2D6 and CYP2C19
Intervention Type
Other
Intervention Name(s)
Clinical decisions support
Intervention Description
Prescribing recommendations to the provider based on the pharmacogenetic testing results
Primary Outcome Measure Information:
Title
Acute Pain - 10 Day SIA Score Change from Baseline
Description
Acute Pain: 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.
Time Frame
Day of Surgery to 10 days post surgery
Title
Chronic Pain -3 Month Pain Control Change from Baseline
Description
Chronic Pain: Pain control, defined as change in the composite pain intensity score from baseline to 3-months in participants who have genotypic or pheno-converted CYP2D6 activity score ≤ 0.75. The composite pain intensity score is derived from the PROMIS pain intensity scale
Time Frame
Baseline to 3 months
Title
Depression - 3 Month Depression Symptom Control Change from Baseline
Description
Depression symptom control, defined as change in PROMIS depression T-scores from baseline to 3-months in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Acute Pain -10 Day Pain Intensity Change from Baseline
Description
PROMIS 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.
Time Frame
10 days post-surgery
Title
Acute Pain Trial - Post-surgery Opioid Usage Change from Baseline
Description
Opioid usage from surgery to10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Time Frame
day of surgery through 10 days post-surgery
Title
Acute Pain Trial - 3 Month Prescription Pain Medication Misuse Change from Baseline
Description
PROMIS prescription pain medication misuse T-scores at 3 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Time Frame
3 months post surgery
Title
Acute Pain - 1 Month Mobility Score Change from Baseline
Description
PROMIS mobility score at 1 month post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Time Frame
1 month post surgery
Title
Acute Pain - Opioid Persistence Change from Baseline
Description
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
Time Frame
3-6 months post-surgery
Title
Chronic Pain - 3 Month Pain Reduction Change from Baseline
Description
Pain reduction is defined as the ratio of the 3 month and baseline composite pain scores in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Time Frame
baseline and 3 months
Title
Chronic Pain - 3 Month Clinically Significant Pain Reduction Change from Baseline
Description
PROMIS prescription pain medication misuse T-scores at 3 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75
Time Frame
3 months
Title
Chronic Pain -3 Month Prescription Pain Medication Misuse Change from Baseline
Description
PROMIS prescription pain medication misuse T-scores at 3 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75
Time Frame
3 months
Title
Depression - 3 Month Change in PHQ of Depression Symptomatology Change from Baseline Scores
Description
Change in PHQ-8 scores between baseline and 3 months in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers. Achieve 50% reduction in scores.
Time Frame
baseline and 3 months
Title
Depression - 3 Month Medication Side Effect Burden Change from Baseline
Description
Side effect burden is defined as the number of side effects experienced from a specified list of possible side effects, weighted by the severity of each side effect in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers
Time Frame
3 months
Title
Depression - 3 Month Medication Adherence Change from Baseline
Description
Medication adherence score derived from the Voils Medication Adherence survey in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers
Time Frame
3 months
Title
Depression - 6 Month Depression Remission Change from Baseline
Description
Remission is defined as whether or not the summed raw responses to the PROMIS emotional distress depression survey is ≤ 16, corresponding to a participant respond "rarely" or "never" to most or all questions.
Time Frame
6 months
Title
All Trials Overall well-being, as measured by PROMIS 43 survey
Description
Overall well-being
Time Frame
At 6 month follow-up
Title
All Trials Concordance between metabolizer phenotype and prescribed medication
Description
Concordance between metabolizer phenotype and prescribed medication
Time Frame
At 6 month follow-up
Title
All Trials Sub-domain of the PROMIS 43 survey: Pain interference
Description
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
Time Frame
At 6 months post return of results (chronic pain and depression; 6 months post surgery for acute pain)
Title
All Trials Sub-domain of the PROMIS 43 survey: physical function
Description
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
Time Frame
At 6 months post return of results (chronic pain and depression; 6 months post surgery for acute pain)
Title
All Trials Sub-domain of the PROMIS 43 survey: sleep disturbance
Description
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
Time Frame
At 6 months post return of results (chronic pain and depression; 6 months post surgery for acute pain)
Title
All Trials Sub-domain of the PROMIS 43 survey: social role and activities functioning
Description
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
Time Frame
At 6 months post return of results (chronic pain and depression; 6 months post surgery for acute pain)
Title
All Trials Sub-domain of the PROMIS 43 survey: fatigue
Description
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
Time Frame
At 6 months post return of results (chronic pain and depression; 6 months post surgery for acute pain)
Title
All Trials Sub-domain of the PROMIS 43 survey: anxiety
Description
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
Time Frame
At 6 months post return of results (chronic pain and depression; 6 months post surgery for acute pain)
Title
All Trials Sub-domain of the PROMIS 43 survey: depression
Description
The assessment scale options are: without any difficulty, with a little difficulty, with some difficulty, with much difficulty or unable to do
Time Frame
At 6 months post return of results (chronic pain and depression; 6 months post surgery for acute pain)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hrishikesh Chakraborty
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Health System
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
University of Florida - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Nemours Children's Health System
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Florida - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Nemours Children's Health System
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Eskenazi Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Institute for Family Health
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Sanford Health
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Nashville General Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35899435
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35899435/
Description
Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators

Learn more about this trial

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

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