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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT04375033
Eligibility Criteria:
Inclusion Criteria:
* Has used opioids within 30 days prior to consent or within 30 days prior to entry into a supervised setting -- e.g., opioid use within the 30 days prior to recent (\<30 days) incarceration, entry into a detoxification facility, or entry into an inpatient hospital setting
* Have started or are in the process of starting on MOUD via clinical induction on SL-BUP/NLX
* Meets DSM-5 criteria for moderate to severe OUD based on the Mini-International Neuropsychiatric Interview
* Referred to/seeking treatment for OUD and willing to accept "partial-agonist-based" therapy
Exclusion Criteria:
* Is a Veteran less than 18 years of age
* For Veterans of childbearing potential (a premenopausal person capable of becoming pregnant), pregnancy, breastfeeding, and/or failure to practice an effective method of birth control
* Failure to reach maintenance dose of 4mg - 32mg SL-BUP/NLX in 45 days or less.
* Taking a form of prescribed maintenance MOUD (e.g., methadone, buprenorphine or XR-NTX) continuously \>45 days prior to randomization
* Has a history of significant adverse effects from buprenorphine and/or naloxone
* Has experienced (within the past 2 weeks) recent suicidal or homicidal ideation that requires acute treatment or hospitalization.
* Is unwilling or unable to provide consent
* Meets criteria for current (past month) DSM-5 severe sedative hypnotic use disorder based on the MINI SHUD module
* Anuria and/or dialysis
* Current moderate to severe COVID-19 symptoms with a risk of intubation or critical illness.
* Medical, psychiatric, behavioral, or logistical condition which, in the judgement of the Local Site Investigator (LSI) or Co-Investigator (Co-I), requires a higher level of acute care and/or makes it unlikely the patient can participate in or complete the 52-week active phase of the study.
* Is actively participating in an interventional clinical trial for which a waiver of dual-enrollment with CSP #2014 has not been obtained.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04375033
Study Brief:
Protocol Section:
NCT04375033