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Pharmacogenetic Testing for Acute Pain Management (ADOPT PGx Trial)
N/A
Waitlist Available
Led By Hrishikesh Chakraborty
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 8 years
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 month follow-up
Awards & highlights
ADOPT PGx Trial Summary
This trial is testing whether or not personalized medicine based on genetic testing can improve pain control and management for people who have surgery.
Who is the study for?
This trial is for English or Spanish speakers with chronic pain, acute post-surgical pain, or depression. Adults and children over 8 years old may qualify if they are being considered for treatment with certain opioids (tramadol, hydrocodone, codeine) or SSRIs. Exclusions include life expectancy under 12 months, cognitive impairment preventing consent, institutionalization, organ transplant history, prior pharmacogenetic testing relevant to the study.Check my eligibility
What is being tested?
The trials test whether genetic testing can guide better pain management after surgery (Acute Pain Trial), improve chronic pain therapy (Chronic Pain Trial), or reduce depression symptoms more effectively than standard care (Depression Trial). Participants will be randomly assigned to immediate genetic-guided therapy or standard care with delayed testing.See study design
What are the potential side effects?
Potential side effects aren't specified but may relate to the use of opioids like tramadol, hydrocodone, codeine in managing pain and SSRIs for treating depression. These can include nausea, drowsiness, constipation for opioids; and fatigue, sexual dysfunction and mood swings for SSRIs.
ADOPT PGx Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 8 years old or older.
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I am 18 years old or older.
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I am currently experiencing severe pain.
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I am currently using or considering tramadol, hydrocodone, or codeine for pain.
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I have been diagnosed with depression.
ADOPT PGx Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Pain - 10 Day SIA Score Change from Baseline
Chronic Pain -3 Month Pain Control Change from Baseline
Depression - 3 Month Depression Symptom Control Change from Baseline
Secondary outcome measures
Acute Pain - 1 Month Mobility Score Change from Baseline
Acute Pain - Opioid Persistence Change from Baseline
Acute Pain -10 Day Pain Intensity Change from Baseline
+18 moreADOPT PGx Trial Design
6Treatment groups
Experimental Treatment
Group I: Depression - Immediate PGx TestingExperimental Treatment2 Interventions
Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider
Group II: Depression - Delayed PGx TestingExperimental Treatment1 Intervention
Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period
Group III: Chronic Pain - Immediate PGx TestingExperimental Treatment2 Interventions
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Group IV: Chronic Pain - Delayed PGx TestingExperimental Treatment1 Intervention
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Group V: Acute Pain - Immediate PGx TestingExperimental Treatment2 Interventions
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Group VI: Acute Pain - Delayed PGx TestingExperimental Treatment1 Intervention
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,415,958 Total Patients Enrolled
74 Trials studying Depression
30,245 Patients Enrolled for Depression
Hrishikesh ChakrabortyPrincipal InvestigatorDuke University
4 Previous Clinical Trials
10,865 Total Patients Enrolled
1 Trials studying Depression
1,461 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 8 years old or older.I experience chronic pain.You are planning to move away in the next 6 months, currently receiving treatment for cancer, or regularly taking opioids other than tramadol, codeine, or hydrocodone.I am scheduled for surgery that will use tramadol, hydrocodone, or codeine for pain.You have been seen at a primary care clinic or a specialty clinic for pain-related issues.I am 18 or older, speak English or Spanish, have had pain for 3+ months, and am considering or on tramadol, hydrocodone, or codeine.I am 8 or older, speak English or Spanish, have depression, and am starting or changing SSRI therapy.You are not expected to live more than a year, cannot understand the study or follow its instructions, are in a care facility or too sick to take part, had a specific type of stem cell or liver transplant, or have taken a gene test for this study before.I have been diagnosed with depression.I am having laparoscopic surgery and have been on opioids for more than 3 months.I have had symptoms of depression for at least 3 months.I do not plan to move soon, and I do not have psychosis, dementia, cognitive disabilities, seizures, or bipolar disorder.I am over 8, speak English or Spanish, and will have surgery needing specific pain meds.I speak English or Spanish.I have been experiencing pain for at least the last 3 months.I am 18 years old or older.I am currently experiencing severe pain.I am currently using or considering tramadol, hydrocodone, or codeine for pain.I have been diagnosed with depression.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Chronic Pain - Delayed PGx Testing
- Group 2: Depression - Immediate PGx Testing
- Group 3: Chronic Pain - Immediate PGx Testing
- Group 4: Depression - Delayed PGx Testing
- Group 5: Acute Pain - Immediate PGx Testing
- Group 6: Acute Pain - Delayed PGx Testing
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04445792 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what number of venues is this experiment being implemented?
"This trial is running at 10 different sites, which can be found in Indianapolis, Jacksonville and New york as well as other nearby cities. To reduce travel needs for the study, it's best to select a location close by."
Answered by AI
What is the capacity of participants in this trial?
"Affirmative. Records hosted on clinicaltrials.gov show that the trial, which started recruiting patients in February 2021, is still seeking more participants from 10 different sites with a total of 4509 candidates desired."
Answered by AI
Are there still available enrollment slots for this trial?
"The latest updates on clinicaltrials.gov suggest that this trial is open to enrollment, having been initially posted on February 10th 2021 and last modified on August 19th 2022."
Answered by AI
What aims are being sought from this clinical experiment?
"The primary evaluation outcome of this study, spanning from the Baseline to 3 months time frame, is Depression - 3 Month Depression Symptom Control Change from Baseline. Additionally, secondary outcomes include All Trials Sub-domain of the PROMIS 43 survey: Pain interference (assessed on a scale ranging from no difficulty up to being unable to do), All Trials Sub-domain of the PROMIS 43 survey: anxiety (again assessed on a scale ranging from without any difficulty up to cannot complete), and Acute Pain -10 Day Pain Intensity Change from Baseline which measures pain intensity at 10 days post surgery with participants who have"
Answered by AI
Who else is applying?
What state do they live in?
Indiana
North Carolina
Maryland
Other
How old are they?
65+
18 - 65
What site did they apply to?
Indiana University
Duke University
Other
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
chronic low back pain due to arthritis, diagnosed as depressive in my early 20s, i am medicated which helps with the depression, but not on any pain medication.
PatientReceived 2+ prior treatments
I have chronic pain related to psoriatic arthritis that I have taken Meloxicam, Humira, and Methotrexate for so far and still struggle with my pain levels, and I also have longterm depression that is currently not being treated, though I have taken many different types of medications for it in the past.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
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