Opioid Abuse (Disorder)

The goal of this study is to conduct a clinical trial to understand effects of providing multilevel intervention to young people in the legal system. The multilevel intervention includes flexible care management using ACRA/ACC principles, family support, and overdose education. This study aims to test the implementation strategy, as well as the outcomes of the intervention with participants. The first question the study will address is how successful was implementation. This will be measured by the number of youth receiving case management, family support, naloxone supplies, and overdose prevention curricula, and adoption by the participating county court systems. The second question the study will address is whether the intervention impacted youth behavioral outcomes, such as overdose risk awareness, knowledge of how to use naloxone, and number of days per month using substances. Researchers will compare youth who received the intervention to youth who received usual treatment to see if the intervention increases overdose risk awareness and knowledge, and decreases frequency of substance use. Participants will receive the intervention (if assigned to) and complete study surveys. Participating counties will provide data on implementation, and site visits will also be performed to track each county's performance.

This study is stage 2, round 3 of a larger study which refines and optimizes the EMBED clinical decision support (CDS) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. See NCT03658642

BRIEF SUMMARY A. "What is the purpose of this study?" BACKGROUND. The QAIAx clinical trial (Quantum AI/AGI Public Health Agency), known operationally as the "AI City Hall Project," represents a landmark intergovernmental research initiative examining the viability of AI-governed residential ecosystems for behavioral and mental health intervention. Authorized under 10 U.S.C. 4001 (Defense Sector Research Projects, RDT\&E) and supported by pending USPTO applications (Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360), this non-medicinal program investigates whether quantum AI-managed public administration, AI humanoid robotics, holographic holoportation (AI-119 Kikkeri Holo-Suit / "AI Wat Beam Bot"; AI-119 Vulcan QM-Ware or "Quasi-Mind Ware"), and advanced AGI learning machines can reduce housing and care costs while improving mental health outcomes-particularly for persons with addiction and co-occurring psychiatric disorders. SCOPE \& JURISDICTION. The trial operates across a network of self-contained, geodesic dome-enclosed "Microcities" (1,500-15,000 occupants per site) within an affiliate network of 300 communities, spanning North America, South America, Europe, Africa, Oceania, Asia, and the Middle East. Participating host nations are U.S.-allied member states party to the Status of Forces Agreement (SOFA), the Vienna Convention on Diplomatic Relations, and the Hague Convention, alongside related bilateral treaties with the U.S. government. INTERVENTION \& POPULATION: Eligible adults (18+) reside in these Microcities for up to 36 months. Daily life-including housing, utilities, and healthcare-is administered by the ISAC AI/AGI system and robots with minimal human oversight. CLINICAL TRIAL GOAL(S): The clinical trial program goals are to exemplify a sustainable AGI-managed public administration supported by AI robotics and AGI trans-human and omni-AI machines (e.g., "Q-Men"; "AI-Me"; Beam Bot", "QM-Ware", "AVK Suit") to improve mental health outcomes-especially for those with addiction disorders-and create a financially sustainable model for people on fixed incomes or public assistance. B. "What conditions does the study focus on?" The study focuses on adults with: * Autism spectrum disorders (Asperger's, autism, ADHD, ASD) * Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA/ecstasy, tobacco/nicotine) * Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders) * Behavioral addictions (gambling, sex addiction) and related issues (sex offence history). C. "What does the study involve?" Eligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital "attitude inoculation" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic. \*\*Who can participate?\*\* You may be able to join if you: * Are an adult (18 years or older) * Have a diagnosis of one of the listed mental-health or addiction disorders * Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organization (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole/probation officer, judge) * Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses. Participants who are veterans, receive public assistance (e.g., VA disability, SSDI/SSI, Medicaid, Medicare), or are experiencing homelessness may be prioritized. \*\*Where is the study taking place?\*\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones. \*\*Who is sponsoring the study?\*\* The study is sponsored by Veterans Recovery Network Inc., a SCDV-owned non-profit organization, in collaboration with AI-119 Vulcan Project Research \& Educational Technology Co. (PRETCO). The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §§§§ 4001, 4021, 4022, and 4023) and is part of a Cooperative Research and Development Agreement (CRADA) with participating segments or RDT\&E programming missions of the United States Defense Department (DoW). This summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.

This project tests a training strategy to help rural jails start or increase their use of medications to treat opioid use disorder (MOUD - methadone, buprenorphine, naltrexone). Staff from participating jails will attend a series of training sessions, called Project ECHO, that include online learning sessions with skilled experts, case-based discussions (real-world examples), and peer-to-peer learning opportunities. Project ECHO is well-studied in healthcare settings but has rarely been used in correctional systems. Staff from 40 rural jails and local treatment programs will participate in 6 months of core sessions (all participants attend the same sessions), followed by 12 months of continuing sessions (where content is tailored to participants' needs). Staff will complete surveys about their knowledge and experience, and jails will provide data about their services. Researchers will measure changes in MOUD services offered by the jails over time, as well as the impact these changes have on staff's work environment. If Project ECHO helps expand MOUD services, it will offer a blueprint for expanding these life-saving services in other jails nationwide.

The goal of this pilot trial is to evaluate the feasibility and acceptability of an adapted MDFT intervention with women who report prior OUD and sex trade involvement participating in specialty court treatment programs. The main question\[s\] the trial aims to answer are: 1. Will the inclusion of the adapted MDFT intervention be feasible among the target population? 2. Will participant dyads assigned to the adapted intervention perceive the intervention as acceptable and beneficial? Participants will be randomly assigned to receive either: 1) the adapted MDFT + TAU; or 2) TAU. Participants will complete baseline and post-intervention assessments.

We want to learn if Patient Navigation helps pregnant Medicaid members with opioid use disorder, with or without stimulant use disorder, stay in care, use medications for opioid use disorder, reduce substance use, and connect with services, compared to usual care. Enrolled participants will be randomly assigned (by chance, like flipping a coin) to one of two groups: Usual Care or Patient Navigation. Participate will last up to 14 months and participants randomized to Patient Navigation may have about 14 sessions/calls with a Patient Navigator (30-45 minutes each) and complete 3 surveys (30-60 minutes each). All visits can be by phone or video.