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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT06023459
Eligibility Criteria:
Inclusion Criteria:
1. Be ≥18 years of age
2. Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for OUD
3. Be interested in receiving buprenorphine treatment for OUD
4. Be willing to be randomized to either SL-BUP or XR-BUP
5. Be willing to comply with all study procedures
6. Be in good general health, as determined by the study Medical Clinician based on medical/psychiatric histories and physical exam, to permit treatment in an outpatient setting
7. If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study intervention and agree to study-administered pregnancy testing during their participation in the study
8. Be able to speak English sufficiently to understand the study procedures
9. Be willing and able to provide written informed consent to participate in the study
Exclusion Criteria:
1. Have evidence of a serious psychiatric disorder as assessed by the study Medical Clinician that would make participation difficult or unsafe (e.g., active psychosis, severe depression, or mania)
2. Have suicidal or homicidal ideation or behavior that requires immediate attention
3. Have a medical condition or serious medical illness that, in the opinion of the study Medical Clinician, would make study participation medically unsafe
4. Have been in treatment with naltrexone within 28 days of consent
5. Have been in methadone maintenance treatment within 28 days of consent
6. Be taking medication or require any medication that, in the judgment of the study Medical Clinician, could interact adversely with study medication
7. Have known allergy or sensitivity to SL-BUP or XR-BUP formulations or their components
8. Be currently incarcerated or have pending legal action that could preclude participation in study activities
9. Have other situation that might prevent the participant from remaining in the area for the duration of the study (e.g., planned move)
10. Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use, as determined by the study Medical Clinician, that would require a different level of care and preclude safe participation in the study
11. Be currently pregnant or breastfeeding or planning on conception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06023459
Study Brief:
Protocol Section:
NCT06023459