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

ID#: NCT04445792

Age: 8 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: February 10, 2021

End Date: February 28, 2023

Contact Information:
Kady-Ann Steen-Burrell
919-530-9711
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. 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.
Eligibility:

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