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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT05905367
Eligibility Criteria:
Inclusion Criteria:
1. Opioid use disorder (OUD) of any severity by DSM-5 Clinical Diagnostic criteria
2. Intentional use of unregulated fentanyl by any route (injection and/or inhalation) by participant self-report
3. Urine drug test (UDT) positive for fentanyl at screening or within 7 days prior to date of screening visit
4. Clinical indication to start OAT with methadone or SROM
5. Willing and able to provide written informed consent for study participation
6. If taking prescribed opioids for safer supply/risk mitigation, willing to discontinue them starting on study Day 1 and for the first 7 days of the study
Exclusion Criteria:
1. Individuals who are pregnant or breast-feeding
2. Currently receiving prescribed fentanyl in any form, e.g. fentanyl patch
3. Previous participation in this study
4. Current use of methadone \>150mg/day or SROM \>1300mg/day or buprenorphine extended-release in any dose
5. Use of buprenorphine-naloxone within the previous 3 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05905367
Study Brief:
Protocol Section:
NCT05905367