- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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).
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Bruno GIORDANA, Dr
- 전화번호: +33 4 92 03 87 75
- 이메일: giordana.b@chu-nice.fr
연구 장소
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Nice, 프랑스
- Chu De Nice
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연락하다:
- Bruno GIORDANA, Dr
- 전화번호: +33 4 92 03 87 75
- 이메일: giordana.b@chu-nice.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: CSAPA outpatients using generative AI
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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).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correlation coefficient between substance use disorder severity and generative AI dependency
기간: Baseline (single cross-sectional assessment, Day 0)
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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).
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Baseline (single cross-sectional assessment, Day 0)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Generative artificial intelligence dependency score broken down by primary substance
기간: Baseline (Day 0)
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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).
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Baseline (Day 0)
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Generative artificial intelligence dependency score broken down by psychiatric comorbidities
기간: Baseline (Day 0)
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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).
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Baseline (Day 0)
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Generative artificial intelligence dependency score broken down by sociodemographic characteristics
기간: Baseline (Day 0)
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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).
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Baseline (Day 0)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .