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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT06416020
Eligibility Criteria:
Inclusion Criteria
1. Be 16 years of age or older
2. Has been newly prescribed MOUD with buprenorphine by a hub clinic provider no more than 10 days before the day of randomization or on the day of randomization \[Note that the "start" of a "current, new treatment episode" of MOUD with buprenorphine is defined as the date MOUD with buprenorphine was prescribed by a hub clinic provider.\]
3. Is willing and able to provide written informed consent
4. Is willing and able to provide reliable locator information to facilitate contacting the participant for research follow-up assessments
5. Speaks English well enough to be able to comprehend the study procedures and complete the assessments
Exclusion Criteria:
1. In the 30 days prior to receiving the prescription for MOUD with buprenorphine from the hub clinic provider, has either taken prescribed MOUD as an outpatient for more than 10 consecutive days OR received injectable MOUD that covers more than 10 consecutive days \[Note that receipt of MOUD in a hospital, residential treatment, or carceral setting would not trigger exclusion.\]
2. Plans to move out of the area or anticipate not being able to remain in the study for 6 months
3. Is currently in jail, prison, or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities
4. Has been previously enrolled in CTN-0144 or CTN-0088 or is currently enrolled in another clinical trial for treatment of OUD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT06416020
Study Brief:
Protocol Section:
NCT06416020