← Back to Search

Pharmacogenetic Testing

Personalized Medicine Approach for Chronic Pain (PGx-ACT Trial)

N/A
Waitlist Available
Led By Max Smith, PharmD
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first encounter (baseline visit), 3 months, 12 months
Awards & highlights

PGx-ACT Trial Summary

This trial will test whether a personalized medicine approach to prescribing opioids for chronic pain results in better pain control for patients.

Who is the study for?
Adults over 18 with chronic pain for at least 3 months, currently prescribed hydrocodone, tramadol, or codeine by a MedStar Health provider and treated at a participating clinic. They must be willing to follow the trial procedures but can't join if they have had certain transplants, opioid use disorder, unapproved narcotic use, prior CYP2D6 testing or recent/post-operative opioids.Check my eligibility
What is being tested?
The study compares two approaches: one where pharmacogenetic testing guides care (intervention arm) and standard care without such guidance (control arm). It aims to see if personalized treatment based on genetic metabolism of drugs improves pain control after three months in patients using specific opioids.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include reactions related to changes in medication regimens following pharmacogenetic testing results. These could range from typical drug side effects like nausea or dizziness to more serious issues depending on individual patient responses.

PGx-ACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first encounter (baseline visit), 3 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and first encounter (baseline visit), 3 months, 12 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
Change in Pain Intensity
Secondary outcome measures
Change in Pain Intensity Among Those with Therapy Concordant with PGx Recommendations
Change in Pain Interference Symptoms
Change in Physical Function
+3 more

PGx-ACT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PGx-guided careExperimental Treatment2 Interventions
Pharmacogenetic results (e.g., CYP2D6, CYP2C9) and a pharmacist consultation will be provided to their primary care provider. This consultation note (PharmD consult) will aid primary care providers in the interpretation and application of PGx results in prescribing decisions. The ultimate prescribing decision is at the discretion of the primary care provider and patient.
Group II: Standard careActive Control1 Intervention
Care for study subjects will occur without PGx results at the discretion of the study subject, their primary care provider. After the active participation ends (i.e. after the three month follow up is complete), PGx results and a PharmD consult will be provided similar to the PGx-guided arm.

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
189 Previous Clinical Trials
115,258 Total Patients Enrolled
1 Trials studying Chronic Pain
94 Patients Enrolled for Chronic Pain
Kailos Genetics, Inc.UNKNOWN
Max Smith, PharmDPrincipal InvestigatorMedStar Health

Media Library

Pharmacogenetic Testing (Pharmacogenetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT04685304 — N/A
Chronic Pain Research Study Groups: PGx-guided care, Standard care
Chronic Pain Clinical Trial 2023: Pharmacogenetic Testing Highlights & Side Effects. Trial Name: NCT04685304 — N/A
Pharmacogenetic Testing (Pharmacogenetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04685304 — N/A

Frequently Asked Questions

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

Are researchers presently accepting participants for the trial?

"Clinicaltrials.gov confirms that this medical study is actively enlisting patients for participation. It was first made public on December 2nd 2020, and its information has been recently updated on March 1st 2022."

Answered by AI

What is the aggregate quantity of participants engaging in this research project?

"Affirmative. According to clinicaltrials.gov, this research project is actively searching for participants and first appeared on December 2nd 2020. Currently, 400 people are needed at 1 medical site for the experiment."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care
2020. "Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04685304.
~73 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top