Addiction Disorders

BRIEF SUMMARY A. "What is the purpose of this study?" This study will test whether the "AI City Hall Project" (QAIAx), a quantum artificial intelligence (AI) public health agency, can provide free or low-cost behavioral and mental health services inside self-contained, dome-enclosed communities called "Microcities". Researchers want to see if AI-managed public administration, AI humanoid robots, holoportation of human-figures via 'holo-suites' (e.g., AI-119 Kikkeri Holo-Suit; AI-119 Vulcan QM-Ware) and advanced AI mental-health tools can lower housing and care costs, improve mental health outcomes (e.g., particular ecosystems using AI tools among persons with one or more addiction disorders), and be financially sustainable 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 organisation (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 prioritised. \*\*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 non-profit organization, in collaboration with \*\*AI-119 Vulcan Project Research \& Educational Technology Co. (PRETCO)\*\* and an AI legal agency. The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §129a) and is part of a Cooperative Research and Development Agreement (CRADA) with U.S. Special Operations Command (USSOCOM). This summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.

The goal of this clinical trial is to evaluate whether an integrated medico-psychosocial vocational support program (ADD'Pro) can improve employment outcomes in adults with substance use disorders receiving care at a specialized addiction day hospital. The main question it aims to answer is: \- Does participation in the ADD'Pro program increase the rate of competitive employment (at least one day worked in the open labour market) at 6 months compared to standard employment services? Researchers will compare participants enrolled in the ADD'Pro program to participants referred to conventional employment services (France Travail or Cap Emploi) to see if structured, dual medico-psychosocial support leads to higher rates of vocational reintegration, better employment preparation, improved quality of life, and reduced physiological stress reactivity. Participants will: * Be randomly assigned to either the ADD'Pro program or standard employment services * If assigned to ADD'Pro: receive immediate individualised support from a vocational counsellor (CIP) at the CeCler Association, running in parallel with their hospital addiction care, with no fixed end date * If assigned to standard care: be referred to conventional employment services with monthly follow-up interviews at the hospital, and the option to join ADD'Pro after 6 months * Complete structured interviews and validated questionnaires at inclusion, 3, 6, and 12 months * A sub-sample of up to 50 participants will additionally take part in a simulated job interview stress test (adapted TSST) with salivary biomarker collection and heart rate monitoring at inclusion and 6 months

In psychiatry, psychotherapy is, along with pharmacotherapy, a major therapeutic intervention. It helps patients better understand their difficulties and informs them of possible solutions. It is systematically recommended in cases of psychiatric disorders, whether or not in combination with pharmacotherapy. With regard to addictive disorders in particular, few medications are available and psychotherapy is essential. Psychotherapy must be adapted to the severity of the patient's condition and the issues encountered. In cases of impaired emotional regulation, i.e., the ability to respond effectively to one's emotions, addictions become more difficult to stabilize without appropriate treatment. For patients with emotional regulation disorders, Dialectical Behavior Therapy (DBT) is the standard treatment. It consists of teaching acceptance and change skills in a dialectical manner to better regulate emotions. Like other evidence-based psychotherapies, DBT is nevertheless not widely available. It requires therapists to have a high level of training and sufficient patient recruitment to form groups. Two solutions are being considered to improve the accessibility of DBT. To facilitate patient recruitment, transdiagnostic groups are useful because they bring together patients with different diagnoses. To help professionals deliver the therapy, digital tools such as pre-recorded videos or mobile applications have proven effective, particularly when guided by a therapist, but they also show some effectiveness without a therapist. Studies are still recent and few in number, and need to be replicated, particularly using a variety of digital tools. The investigators want to evaluate the effectiveness of DBT on emotional regulation and impulsivity in addiction patients, in a transdiagnostic face-to-face format and in an online format using videos, compared to a control group (usual treatment). This research would provide a better understanding of the effectiveness of DBT in addiction treatment, as well as the effectiveness of solutions that improve its accessibility, such as the transdiagnostic format and the use of associated digital tools.

The study is an open prospective cohort study. Participants are assessed at the start of their care in an addiction treatment unit using the Addiction Severity Index (ASI) and the Mini International Neuropsychiatric Interview (MINI), which are routinely conducted in these centers for individuals with substance use or behavioral disorders. After the study protocol is explained, the evaluator checks eligibility criteria, interested participants provide their written informed consent. The evaluator invites participants to complete self-administered questionnaires at home, which are returned during a session that also includes cognitive testing. Follow-up interviews are scheduled at 3 months, 6 months, and every 6 months thereafter.

The objective of this interventional study is to evaluate the effectiveness of the Mindful Self-Compassion (MSC) program in reducing alcohol consumption in a population of individuals with Alcohol Use Disorder (AUD), six months after the intervention. The MSC program was designed to enhance self-compassion skills. It has demonstrated a mediating effect on symptoms of stress, depression, and anxiety, which are known to contribute to the maintenance of AUD. Outpatients with AUD will be included after providing informed consent and will be randomized into two groups (MSC+TAU vs TAU). The follow-up includes 13 visits over a 9-month period, with group sessions according to allocation. Three follow-up visits are scheduled up to six months after the end of the sessions. Participants will complete several scales and surveys (AUDIT, TLFB, SCS, HAD, SSS-S, TOSCA-3, AQoLS, MAAS, Fagerström, CUDIT-R, EVA craving).

The morbi-mortality and social cost of addictive disorders led the French authorities to set up a government plan in 2018 to combat drugs and addictive behavior (Interministerial mission to combat drugs and addictive behaviour - (MILDECA)). In particular, it encourages early detection, which is the first stage in a validated global approach to the management of addictive disorders. Improving early identification of addictive disorders in primary care would reduce morbidity and mortality and improve quality of life for patients with addictive disorders. The identification of use disorders should be systematic in primary care and was the subject of a recommendation in 2015. Numerous tests are cited in these recommendations, but few have actually been validated in primary care, and none has been shown to be feasible. For example, only 23% of GPs claim to systematically identify alcohol consumption. Other primary care professionals (physiotherapists, nurses, midwives, dentists, pharmacists) also have a role to play in identifying addictive disorders. The evolution of their respective professions (delegation of tasks, creation of the profession of advanced practice nurse, medical assistants) and the recent reorganization of the practice framework, both in terms of practice structures and professional community organizations, involve them in a global multidisciplinary collaboration on patient care, particularly in the early identification of addictive disorders. The hypothesis is that the difficulties in implementing tests to identify addictive disorders in primary care are linked to the lack of specific consideration of the needs of primary care patients and caregivers. The overall aim of the study is to improve the early detection of addictive disorders through brief training for primary care healthcare professionals.