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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT04352166
Eligibility Criteria:
Inclusion Criteria:
* Individuals between the age of 18-65
* Voluntarily seeking treatment for opioid use
* Meets current DSM-5 criteria for Opioid Use Disorder as a primary diagnosis, with at least moderate severity
* Test positive for high potent synthetic opioids (HPSO) use
* Able to provide informed consent and comply with study procedures
Exclusion Criteria:
* Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis
* Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk
* Methadone maintenance treatment within the past 30 days
* Buprenorphine maintenance treatment within the past 30 days
* Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
* Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients; male participants are required to use adequate forms of birth control as the exposure to sublocade on sperm and subsequent fetal development are not known
* Unstable medical conditions, which might make participation hazardous such as uncontrolled hypertension (blood pressure \>150/100), acute hepatitis, uncontrolled diabetes, or elevated liver function tests (AST and ALT \>3 times the upper limit of normal
* Legally mandated to substance use disorder treatment
* Current physiological dependence on alcohol or sedative-hypnotics that would require a medically supervised detoxification-other substance use diagnoses are not exclusionary
* Individuals, who in the clinicians judgment, have a history of failed trial of buprenorphine or sublocade (e.g., history of severe opioid intoxication or overdoses despite adequate adherence to buprenorphine or sublocade), or other features of the history strongly suggest the patient is not a good candidate for outpatient treatment with buprenorphine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04352166
Study Brief:
Protocol Section:
NCT04352166