Clinical Research Directory

QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)

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.

MDMA-Assisted Therapy for Pathological Narcissism

This open-label, proof-of-concept pilot study will assess the efficacy and safety of midomafetamine (MDMA) - assisted therapy (AT) for participants diagnosed with pathological narcissism. As all participants will be allocated to a single group assignment, there will be no blinding, randomization, or comparator treatment. Participants will have a screening visit, a preparation period of 3 visits, a treatment period receiving MDMA-AT at 3 monthly visits, a 6 month follow up period coming in at one week, one month, three months and six months after last treatment visit.

Evaluation of a Dimensional Adaptation of Good Psychiatric Management (GPM-extended) for the Treatment of Borderline Personality Disorder

The goal of this clinical trial is to evaluate whether a dimensional adaptation of Good Psychiatric Management (called GPM-extended) is more effective than classic Good Psychiatric Management (GPM) in treating adult patients with borderline personality disorder (BPD). Briefly, the GPM-extended model integrates elements from existing adaptations of GPM for narcissistic and obsessive-compulsive personality disorders. It aims to provide a more personalized and dimensional approach to treatment, tailored to each patient's specific personality dysfunction and interpersonal triggers. The main questions it aims to answer are: * Does GPM-extended improve overall BPD symptom severity more than classic GPM after one year of treatment? * Does GPM-extended lead to better outcomes in related clinical domains (e.g., personality functioning, emotional regulation, social functioning...) ? Researchers will compare two groups: * Patients treated in a center using the GPM-extended program. * Patients treated in a center using the classic GPM program. In each group, patients will receive weekly outpatient psychiatric care for one year. In terms of evaluation, patients will be evaluated at baseline, 4 months, 8 months, and 1 year. They will undergo both clinician-administered and self-report assessments to measure BPD symptoms and other relevant psychological dimensions. This study hopes to contribute to the development of dimensional evidence-based treatments for personality disorders.