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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT05339256
Eligibility Criteria:
Inclusion Criteria:
* meet DSM-5 criteria for OUD
* Voluntarily seeking buprenorphine treatment for OUD
* Able to provide informed consent and comply with study procedures
Exclusion Criteria:
* Meeting DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis that would compromise safety of participation in the trial as determined by the study physician, such as an alcohol or sedative hypnotic use disorder that requires detoxification
* Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as a psychotic disorder including schizophrenia or schizoaffective disorder
* Concurrent methadone, buprenorphine, or vivitrol maintenance treatment
* Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
* Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients
* Unstable medical conditions, such as severe hepatic, renal, or cardiovascular disease, which might make participation
* Current or recent history history of significant violent or suicidal behavior or risk for suicide or homicide
* Legally mandated to substance use disorder treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05339256
Study Brief:
Protocol Section:
NCT05339256