- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07819851
A Study of the Correlation Between the Severity of Substance Use Disorder and the Intensity of Dependence on Generative Artificial Intelligence (ADDICT-IA)
This bicentric, cross-sectional observational study conducted in France evaluates the relationship between substance use disorder (SUD) severity and generative artificial intelligence dependency among outpatients treated in specialized addiction care centers (CSAPA).
While conversational generative artificial intelligence tools have seen rapid widespread adoption, potential problematic usage and cognitive dependency remain poorly documented in clinical addictology. Outpatients followed for substance use disorders present shared cognitive, reward-processing, and behavioral vulnerabilities that may heighten their susceptibility to emerging digital dependencies.
Eligible adult patients complete a single 15-minute evaluation comprising the Generative Artificial Intelligence Dependency Scale (GAIDS; 11 items rated on a 5-point Likert scale from 1 to 5, total score range: 11 to 55) and the DSM-5 diagnostic criteria checklist for their primary substance of abuse, alongside sociodemographic characteristics. Clinical data, including documented psychiatric comorbidities, are extracted in parallel from electronic health records. Following questionnaire completion, participants receive a dedicated debriefing and clinical restitution interview with an investigator.
The primary objective is to evaluate the linear correlation between SUD severity (number of validated DSM-5 criteria, from 0 to 11) and generative artificial intelligence dependency intensity (total raw GAIDS score). Secondary objectives aim to describe generative artificial intelligence dependency levels across specific primary substance classes (alcohol, tobacco, cannabis, cocaine, opioids, etc.), documented comorbid psychiatric disorders (e.g., mood disorders, ADHD, anxiety, personality disorders), and sociodemographic subgroups (age brackets, sex, education, and occupational status).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bruno GIORDANA, Dr
- Número de teléfono: +33 4 92 03 87 75
- Correo electrónico: giordana.b@chu-nice.fr
Ubicaciones de estudio
-
-
-
Nice, Francia
- Chu De Nice
-
Contacto:
- Bruno GIORDANA, Dr
- Número de teléfono: +33 4 92 03 87 75
- Correo electrónico: giordana.b@chu-nice.fr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patient (aged 18 years or older), with or without legal protection measures
- Actively followed for a substance use disorder (SUD) characterized according to DSM-5 criteria at a participating specialized addiction care center (Nice University Hospital or Sainte-Marie Hospital in Nice, France).
- Self-reported use of a conversational generative artificial intelligence tool at least once in the past 12 months.
- Ability to understand, read, and complete a self-administered questionnaire in French.
- Oral non-opposition obtained from the patient (and from their legal representative if applicable).
- Affiliated with or beneficiary of a French social security healthcare system.
Exclusion Criteria:
- Minor patient (< 18 years old).
- Major neurocognitive disorders, intellectual disability, or acute psychiatric decompensation precluding comprehension or questionnaire completion.
- Explicit opposition to participate expressed by the patient or their legal representative.
- Withdrawal of non-opposition during the study.
- Incomplete questionnaire or clinical record preventing computation of primary scores.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: CSAPA outpatients using generative AI
|
Administration of a single cross-sectional self-questionnaire assessing generative AI dependency (11-item GAIDS scale), DSM-5 substance use disorder criteria (0 to 11 criteria), and sociodemographic data, followed by a personalized debriefing and clinical restitution interview with an investigator (total duration: approximately 15 minutes).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation coefficient between substance use disorder severity and generative AI dependency
Periodo de tiempo: Baseline (single cross-sectional assessment, Day 0)
|
Linear correlation coefficient (Pearson or Spearman, depending on distribution normality) between the number of validated DSM-5 criteria for the primary substance (score ranging from 0 to 11, higher scores indicate greater severity) and the total raw score on the Generative Artificial Intelligence Dependency Scale (GAIDS; 11 items rated on a 5-point Likert scale from 1 to 5; total score range: 11 to 55; higher scores suggest greater dependency).
|
Baseline (single cross-sectional assessment, Day 0)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Generative artificial intelligence dependency score broken down by primary substance
Periodo de tiempo: Baseline (Day 0)
|
Descriptive statistics (mean +/- standard deviation or median) of the total raw score on the Generative Artificial Intelligence Dependency Scale (GAIDS; 11 items rated on a 5-point Likert scale from 1 to 5; total score range: 11 to 55; higher scores suggest greater dependency) broken down by primary substance classes (alcohol, tobacco, cannabis, cocaine hydrochloride, crack cocaine, opioids, benzodiazepines, amphetamines, other substances).
|
Baseline (Day 0)
|
|
Generative artificial intelligence dependency score broken down by psychiatric comorbidities
Periodo de tiempo: Baseline (Day 0)
|
Descriptive statistics (mean +/- standard deviation or median) of the total raw score on the Generative Artificial Intelligence Dependency Scale (GAIDS; 11 items rated on a 5-point Likert scale from 1 to 5; total score range: 11 to 55; higher scores suggest greater dependency) broken down by documented DSM-5 psychiatric comorbidities (unipolar depressive disorders, bipolar disorders, schizophrenia spectrum and other psychotic disorders, ADHD, ASD, anxiety disorders, OCD, PTSD, borderline personality disorder, antisocial personality disorder, eating disorders, other, or absence of disorder).
|
Baseline (Day 0)
|
|
Generative artificial intelligence dependency score broken down by sociodemographic characteristics
Periodo de tiempo: Baseline (Day 0)
|
Descriptive statistics (mean +/- standard deviation or median) of the total raw score on the Generative Artificial Intelligence Dependency Scale (GAIDS; 11 items rated on a 5-point Likert scale from 1 to 5; total score range: 11 to 55; higher scores suggest greater dependency) broken down by sociodemographic characteristics: age brackets (18-24, 25-39, 40-59, 60+), sex, occupational status (employed, student/in training, unemployed), and highest educational level (less than high school, high school diploma, short higher education, long higher education).
|
Baseline (Day 0)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-PP-15
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .