Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT03743402
Eligibility Criteria:
Inclusion Criteria:
* age 18-80 years
* receiving care at a Kaiser Washington primary care clinic;
* Chronic Non-Cancer Pain, defined as patient-reported pain on more than half the days in the past 6 months;
* currently on higher-dose long-term opioid therapy, defined as \>90 days' supply in the past 180 days with a mean daily dose of 40 mg MED or greater in the past 90 days, as first identified via Kaiser's pharmacy dispensing data and subsequently validated by patient self-report during screening for the trial
* consent to participate in the study arm to which they are randomly assigned
* able to read, speak, and write English adequate for outcome measures
* enrollment in Kaiser for at least 6 months prior and no plans to disenroll over the next year.
Exclusion Criteria:
* receiving treatment for cancer
* enrollment in palliative or hospice care
* use in past year of parenteral, transdermal, or transmucosal opioids
* residing in nursing home or assisted living
* using any implanted device for pain control
* psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year
* current suicidal ideation with plan or intent
* dementia diagnosis in Electronic Health Record
* Patients on buprenorphine for any reason, or methadone or naltrexone for treatment of Opioid Use Disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03743402
Study Brief:
Protocol Section:
NCT03743402