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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT05481112
Eligibility Criteria:
Inclusion Criteria:
1. Incarcerated adults able to provide written informed consent in English.
2. Currently sentenced with pending release date between 3-7 months.
3. Current moderate-to-severe opioid use disorder (DSM-5)
4. Reasonable likelihood of completing 3-months or longer of community treatment (i.e., no plans to be transferred out of state or to another correctional facility)
5. Willing to accept being randomized to initiating XR-B treatment at the time of jail admission or near the time of release.
Exclusion Criteria:
1. Severe medical or psychiatric disability making participation unsafe or regular follow-up unlikely, including patients with pre-existing moderate to severe hepatic impairment are not eligible to participate
2. Pregnancy, planning conception, or breast-feeding
3. Allergy, hypersensitivity or medical contraindication to either medication
4. Chronic pain requiring opioid pain management
5. On methadone or buprenorphine (SL-B) maintenance prior to incarceration AND intending to remain on methadone or buprenorphine maintenance upon return to the community.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05481112
Study Brief:
Protocol Section:
NCT05481112