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:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT03698669
Eligibility Criteria:
Inclusion Criteria:
1. Between 18 and 65 years of age
2. Have chronic pain, defined as pain duration for at least three months with a mean score of 4 or higher on the Brief Pain Inventory (BPI) Pain Interference Scale
3. Pain severity of 4 or higher on a numerical rating scale (0-10) indicating "worst pain in the last week"
4. If using an antidepressant, the dose must be stable for the previous 2 months
5. Has received buprenorphine from the current primary care provider for at least the last month
6. Continuing buprenorphine with no plan to taper dose for the next 12 months
7. Score of ≥4 on Personal Health Questionnaire-9 instrument (at least "mild" depression severity)
8. Gives informed consent to participate in the study.
Exclusion Criteria:
1. Expected surgery in the next 3 months
2. Pain thought to be due to cancer, infection, or inflammatory arthritis
3. Greater than or equal to 10 days of cocaine/crack/methamphetamine use in the past month
4. Current (past month) mania or past year psychosis as determined via Structured Clinical Interview for DSM-5 (SCID) Module's A and B/C
5. Lifetime diagnosis of schizophrenia or other chronic psychotic condition as determined by the study PI
6. Planning to stop using buprenorphine in the next 6 months
7. Pregnancy or planned pregnancy in the next 6 months.
8. Greater than 8 homeless nights in the past month
9. Suicide ideation or behavior requiring immediate attention
10. Not able to provide informed consent
11. Not able to complete interviews in English
12. Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future.
13. Greater than or equal to 45 days without a phone in the past 3 months/no reliable access to phone
14. Headache/migraine as the only site of pain
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03698669
Study Brief:
Protocol Section:
NCT03698669