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Clinical Decision Support

Pharmacogenetic-Guided Opioid Therapy for Chronic Pain (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
Currently treated or being considered for treatment with tramadol, hydrocodone, or codeine to improve pain management
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

ADOPT PGx Trial Summary

This trial studies whether genetic testing and genotype-guided opioid therapy can improve pain control in people with slower-than-normal drug metabolism.

Who is the study for?
This trial is for adults over 18 who speak English or Spanish, have had chronic pain for at least 3 months, and are treated with certain pain meds like tramadol. It's not for those too ill to consent, in institutions, moving soon, on daily opioids (except specific ones), with short life expectancy, past organ transplants, prior genetic testing relevant to the study or active cancer treatment.Check my eligibility
What is being tested?
The Chronic Pain Trial tests if using pharmacogenetic testing to guide opioid therapy can better manage pain compared to standard care. Participants will be randomly placed into two groups: one gets immediate genetic testing and tailored pain treatment; the other receives this after a six-month delay.See study design
What are the potential side effects?
While specific side effects aren't listed here as it's a test of personalized medicine approaches rather than new drugs per se, potential side effects may relate to the use of opioids such as nausea, constipation, drowsiness or risk of dependency.

ADOPT PGx Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently using or considering tramadol, hydrocodone, or codeine for pain.
Select...
I am 18 years old or older.

ADOPT PGx Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3 Month Pain Control Change from Baseline
Secondary outcome measures
3 Month Clinically Significant Pain Reduction Change from Baseline
3 Month Pain Reduction Change from Baseline
3 Month Prescription Pain Medication Misuse Change from Baseline

ADOPT PGx Trial Design

2Treatment groups
Experimental Treatment
Group I: 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 II: 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

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,364 Previous Clinical Trials
3,419,594 Total Patients Enrolled
22 Trials studying Chronic Pain
10,085 Patients Enrolled for Chronic Pain
National Human Genome Research Institute (NHGRI)NIH
263 Previous Clinical Trials
283,084 Total Patients Enrolled
Hrishikesh ChakrabortyPrincipal InvestigatorDuke University
4 Previous Clinical Trials
13,928 Total Patients Enrolled
1 Trials studying Chronic Pain
4,111 Patients Enrolled for Chronic Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently available for participants to join?

"According to the records available on clinicaltrials.gov, this trial is actively enrolling participants as of now. The initial posting for the study was back in February 10th 2021 and recent updates were made during July 21st 2023."

Answered by AI

To what extent is enrollment available for this clinical trial?

"This medical trial necessitates the involvement of 993 participants who meet its requirements. Potential candidates can take part from University of Florida - Jacksonville in Jacksonville, Indiana and Eskenazi Health in Indianapolis, New york among other locations."

Answered by AI

Is this trial being conducted across multiple locations in the city?

"Currently, 10 clinical trial sites are accepting participants. These locations range from Jacksonville to Indianapolis and New york, so there is likely a site near you. It's recommended that patients select the closest clinic in order to reduce travel needs if they join this study."

Answered by AI

Who else is applying?

What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial)
2021. "A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05966142.
~0 spots leftby Apr 2024
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