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Идёт набор NCT07734363

Role of Craving in the Transition Across Level of Addiction Severity: A Longitudinal Study.

Наблюдательное Addiction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Observational assessments (EMA and annual DSM-5 evaluations).
Кому может быть актуально
Состояния в реестре: Addiction. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Symptom Networks Characteristics and Centrality of Craving as Markers of Transition Across Levels of Addiction Severity: A Longitudinal Study

Обзор

Substance/Alcohol Use disorders are defined as a loss of control over the use despite harmul consequences, as well as an intense and persistent urge to use, also called craving. Previous research has shown that craving is central among the diagnostic criteria for addiction, suggesting that it may be important in the onset and persistence of addiction. Addiction develops progressively, and it appears crucial to identify predictive markers of the transition from one level of severity to another over time. One hypothesis is that more closely linked symptoms (meaning symptoms that influence each other more) could be associated with greater severity and/or with the evolution of addiction severity over time. The aim of this project is to explore how the characteristics of the association between addiction symptoms (diagnostic criteria and symptoms as they occur in daily life), and the importance of craving relative to other symptoms, could serve as markers of different addiction severities and of the transition across these levels of severity.

Подробное описание

Exploratory analyses will assess whether craving network metrics, including craving symptom centrality, network global strength, and node predictability, are associated with participant characteristics and clinical measures. Potential predictors and correlates will include sociodemographic characteristics, addiction type and history, psychiatric comorbidities, addiction severity, cognitive performance, personality traits, insight, interoceptive awareness, anxiety and depressive symptoms, childhood trauma, and quality of life. These variables will be assessed using age and sex data, addiction history variables, the Mini International Neuropsychiatric Interview, Addiction Severity Index, Montreal Cognitive Assessment, Iowa Gambling Task, Stroop task, UPPS-P Impulsive Behavior Scale, Sensation Seeking Scale, Temperament and Character Inventory, HAIS-m, MAIA-2, Beck Anxiety Inventory, Beck Depression Inventory, Childhood Trauma Questionnaire-Short Form, and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form. Associations will be explored using correlation and regression analyses, as appropriate to the distribution and measurement level of each variable, at baseline and at the 1-year and 2-year follow-ups.

Вмешательства

  • Другое Observational assessments (EMA and annual DSM-5 evaluations)
    Participants are observed over two years. Annual DSM-5 diagnostic criteria for substance use disorders (SUD) are assessed, and participants complete 2-week EMA protocols measuring substance use, craving, and related factors four times per day. No intervention is administered.

Первичные конечные точки

  • Craving centrality in the DSM-5 Substance Use Disorder diagnostic criteria network [Срок оценки: Baseline, 1-year follow-up, 2-year follow-up]
  • Global connectivity of the DSM-5 Substance Use Disorder diagnostic criteria network [Срок оценки: Baseline, 1-year follow-up, 2-year follow-up]
  • Predictability of nodes in the DSM-5 Substance Use Disorder diagnostic criteria network [Срок оценки: Baseline, 1-year follow-up, 2-year follow-up]
  • Differences in DSM-5 Substance Use Disorder diagnostic criteria network structure [Срок оценки: Baseline, 1-year follow-up, 2-year follow-up]
  • Temporal network structure of ecological momentary assessment (EMA) symptoms [Срок оценки: Baseline, 1-year follow-up, 2-year follow-up]
  • Contemporaneous network structure of ecological momentary assessment (EMA) symptoms [Срок оценки: Baseline, 1-year follow-up, 2-year follow-up]
  • Between-subject network structure of ecological momentary assessment (EMA) symptoms [Срок оценки: Baseline, 1-year follow-up, 2-year follow-up]
  • Individual network invariance assessed by the Individual Network Invariance Test (INIT) [Срок оценки: Baseline, 1-year follow-up, 2-year follow-up]

Критерии участия

Критерии включения

  • Be over 18 years of age
  • Identify a primary substance as a main problematic substance use.
  • Be a regular user (at least twice a week in the last 30 days) of a primary substance (defined as their main problematic substance use).
  • Present a current diagnosis of SUD for this primary substance according to DSM-5 criteria.

Критерии исключения

  • Medical, psychiatric or addiction condition that warrants immediate inpatient treatment intervention.
  • Somatic, cognitive or other disorders preventing the use of the smartphone device (deafness, impaired vision, illiteracy….).
  • Not being familiar with the use of smartphone
  • Having a smartphone not compatible with the application and being unable to visit the laboratory to receive a loaner phone for the study.
  • Difficulty in understanding and/or writing and/or reading French.
  • Individuals participating in another study that includes an ongoing exclusion period.
  • Be deprived of liberty due to an ongoing legal procedure.
  • Be under legal protection.
  • Be under guardianship or conservatorship.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Université de Bordeaux CNRS UMR 6033 SANPSY — Bordeaux

Идентификаторы

NCT: NCT07734363 · 26.00741.000491 · 2026-A00034-47

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗