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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT06454903
Eligibility Criteria:
Inclusion Criteria:
For the Phase 3, Stage 1b RCT we will be recruiting Veterans enrolled within the VA CT Healthcare System with:
* Current diagnosis of Opioid Use Disorder (OUD) indicated by either DSM-5-TR or ICD-9 or -10 codes
* Active Medication treatment for OUD prescription for buprenorphine or methadone (in any formulation)
* A working smartphone with wireless capabilities (to allow for download of ACT to RECOVER) or is willing to use a study-provided smartphone
* Competency to provide written informed consent
* 18 years of age or older
Exclusion Criteria:
Participants may not:
* Have been on MOUD, in their current treatment episode (i.e., since their most recent induction), for longer than 12 consecutive months prior to their baseline visit
* Have untreated major psychiatric disorders (e.g., bipolar disorders, psychotic disorders)
* Be expressing current, active suicidal/homicidal ideation (i.e., current intent to harm themselves or someone else)
* Have any cognitive/medical impairment precluding study participation or use of smartphones/smartphone applications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06454903
Study Brief:
Protocol Section:
NCT06454903