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Early Addiction Care Pathway After Acute Drug Intoxication in Emergency Departments (IPAIS)

27 de julho de 2026 atualizado por: Assistance Publique - Hôpitaux de Paris

Interventions Précoces en Addictologie Dans le Cadre Des Urgences Par Intoxications aiguës Aux Stupéfiants (IPAIS)

Acute intoxication with psychoactive substances represents a major public health issue and a frequent reason for emergency department (ED) visits. Beyond the acute medical management of intoxication, one of the main challenges remains the continuity of addiction care after discharge. Many patients disengage rapidly from follow-up services, leading to recurrent intoxication episodes, repeated ED admissions, and increased morbidity.

The IPAIS study (Interventions Précoces en Addictologie dans le cadre des urgences par Intoxications aiguës aux Stupéfiants) is a multicenter, randomized, parallel-group, open-label clinical trial designed to evaluate whether an enhanced early addiction care pathway improves retention in addiction treatment among patients admitted to emergency departments for acute intoxication involving at least one illicit psychoactive substance (excluding isolated alcohol intoxication).

All participants will receive an early addiction consultation within 24 to 72 hours following the acute event. In the experimental group, this consultation will be combined with a structured and standardized feedback session on toxicological analysis results and a proactive follow-up strategy including scheduled telephone contacts over a 6-month period. The control group will receive early addiction consultation according to usual care procedures, without the structured feedback and standardized follow-up program implemented in the experimental arm.

The primary objective of the study is to determine whether the enhanced intervention improves retention in the addiction care pathway at 6 months after inclusion. Retention is defined as sustained engagement in addiction care, operationalized as at least one addiction-related consultation per month and/or regular telephone-based addiction follow-up over the 6-month period.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Acute intoxication with psychoactive substances is a major public health issue and a frequent reason for emergency department visits. Beyond the acute medical management of intoxication, a key challenge remains ensuring continuity of addiction care after discharge. Many patients quickly disengage from follow-up services, leading to recurrent episodes of intoxication, repeated emergency department admissions, and increased morbidity.

The IPAIS study (Early Addiction Interventions in Emergency Settings for Acute Intoxication with Illicit Drugs) is a multicenter, randomized, parallel-group, open-label clinical trial designed to evaluate whether an enhanced early addiction care pathway improves retention in addiction treatment among patients admitted to the emergency department for acute intoxication involving at least one illicit psychoactive substance (excluding isolated alcohol intoxication).

All participants will receive an early addiction consultation within 24 to 72 hours of the acute event. In the experimental group, this consultation will be combined with a structured, standardized feedback session regarding toxicology results and a proactive follow-up strategy involving scheduled telephone contacts over a 6-month period. The control group will receive an early addiction consultation according to standard care procedures, without the structured feedback and standardized follow-up program implemented in the experimental group.

The primary objective of the study is to determine whether the enhanced intervention improves retention in the addiction care pathway 6 months after enrollment. Retention is defined as sustained engagement in addiction care, operationalized as at least one addiction-related consultation per month and/or regular telephone follow-up over the 6-month period.

Tipo de estudo

Intervencional

Inscrição (Estimado)

266

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • França
      • Paris, França, 75012
      • Paris, França, 75020
        • Hôpital Tenon
      • Paris, França
      • Paris, França, 75013
        • Unité d'Addictologie Hospitalière/ELSA Hôpital Pitié Salpêtrière
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

Patients admitted and/or hospitalized in the emergency department or intensive care unit following acute poisoning must:

  • Be over 18 years of age
  • Have consumed at least one identifiable non-alcoholic narcotic, including psychoactive substances detected by standard urine drug screening (dipstick)
  • Have a history of using at least one non-alcoholic psychoactive substance within the last 30 days
  • Speak and understand French
  • Have at least 1 cm of hair
  • Be covered by a social security scheme (member or dependent)
  • Be the patient or a relative/close contact/trusted person who has been informed about the study and has given their informed consent (or completed the emergency inclusion procedure)
  • Have a mobile phone number or email address to be contacted

Exclusion Criteria:

  • Acute suicidal crisis requiring priority psychiatric care
  • Acute alcohol intoxication (after confirmation by urine drug screening in the Emergency Department)
  • Acute episode related to exclusive opiate use, requiring opiate substitution therapy
  • Prolonged hospitalization in intensive care or follow-up care due to complications of alcohol intoxication beyond 8 days after the initial addiction assessment
  • Protected patient: under a valid legal guardianship, curatorship, or conservatorship
  • Patient requiring involuntary psychiatric hospitalization

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Structured early addiction care
Participants randomized to the experimental arm receive a structured, protocol-based early addiction care pathway initiated during hospitalization for acute intoxication. The intervention includes a standardized addiction assessment, scheduled addiction follow-up visits (1-2 contacts per month) over a 6-month period, structured harm reduction evaluation, and systematic feedback of biological toxicology results, including hair analysis, at predefined timepoints (Month 1, Month 3, Month 4, and Month 6). Follow-up contacts may include in-person consultations and protocolized telephone interviews delivered by addiction specialists or trained psychologists.
Comportamental: Structured early addiction care

The intervention consists of a structured early addiction care program initiated during hospitalization for acute psychoactive substance intoxication. It includes:

  • A standardized addiction consultation during the index hospitalization;
  • A protocolized follow-up schedule over 6 months, with 1-2 structured contacts per month (in-person or telephone);
  • Systematic harm reduction assessment and counseling at predefined visits;
  • Collection and structured feedback of toxicological results (urine, blood, and hair samples), including discussion of discrepancies between declared and detected substance use;
  • Reinforcement of linkage to addiction services and maintenance in the care pathway.

The intervention aims to enhance patient engagement, insight into substance use patterns, and long-term retention in addiction care.
Outro: Not structured early addiction care
Participants randomized to the control group receive addiction follow-up with randomized interviews and/or workshops, at least once a month, for a duration of 6 months or as requested by the patient, and harm reduction assessments at months 1, 3, 4, and 6, disregarding toxicology results. Follow-up contacts may include in-person consultations and structured telephone interviews conducted by trained substance abusers or psychologists.
Comportamental: Not structured early addiction care

The intervention consists of a streamlined consultation with the implementation of addiction follow-up, possibly via video and telephone, and "treatment as usual" with routine toxicology tests typically used in most emergency departments. This program includes:

  • A standardized addiction consultation during initial hospitalization;
  • Addiction follow-up with random interviews and/or workshops, at least once a month, lasting 6 months or at the patient's request;
  • A systematic harm reduction assessment and support during pre-defined consultations, without taking into account the results of hair samples tests;
  • Collection of toxicology results (hair follicle), including a discussion of discrepancies between reported and detected substance use, at the end of the study at month 6.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Retention in addiction care at 6 months
Prazo: 6 months after randomization

Proportion of randomized participants who are still actively engaged in a structured addiction care pathway 6 months after randomization.

Retention is defined as attendance at ≥1 scheduled addiction care contact (in-person visit, structured psychological session, or protocol-defined telephone follow-up) within the predefined follow-up window around Month 6 (±30 days), without documented loss to follow-up or withdrawal from addiction care.
6 months after randomization

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Rate of recurrent acute intoxication episodes.
Prazo: 3 months and 6 months after randomization
Proportion of randomized participants experiencing at least one new episode of acute intoxication requiring emergency department visit or hospitalization within 3 months and within 6 months after randomization. A recurrent acute intoxication episode is defined as a documented presentation to an emergency department or hospital admission for acute poisoning related to new psychoactive substances (NPS) or other psychoactive drugs occurring after the index episode that led to study inclusion. Data will be collected through hospital medical records review and structured follow-up interviews. Separate proportions will be calculated at 3 months and 6 months.
3 months and 6 months after randomization
Change in Anxiety and depression score
Prazo: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months

Assenssment of Anxiety and depression using the HADS scale : Hospital Anxiety and Depression Scale, between baseline and 6 months.

Anxiety subscale from 0 to 21 Depression subscale from 0 to 21 A higher score indicates a more severe condition (worse result).
Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in health-related quality score
Prazo: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Assenssment of health-related quality usign the Short Form-36 (SF-36), between baseline and 6 months. SF-36 ranging from 0 to 100. A higher score indicates a better quality of life (better outcome)
Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in severity of sleep disorders score
Prazo: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Assessment of sleep disorders usign the Insomnia Severity Index scale (ISI) between baseline and 6 months, rangin from 0 to 28. A higher score indicates more severe insomnia.
Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in Need for thrills score
Prazo: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months

Assenssment of the need for thrills using the Sensation Seeking Scale (SSS),between baseline and 6 months, raging from 0 to 40 (for the short version).

A higher score indicates a more pronounced need for sensation.
Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in drug use practices : weekly Number of Drug Use Sessions
Prazo: From baseline (inclusion) to 6 months; assessed at Month 1 (M1), Month 3 (M3), Month 4 (M4), and Month 6 (M6)

Evolution of individual weekly number of substance use sessions (sessions/week) - all substances combined or by substance, as reported by the participant -, between baseline and 6 months (at M1, M3, M4, and M6), using the CANDITOX questionnaire (Assessment of the infectious risks related to intravenous drug use) -not validated, but routinely used in clinical practice for evaluating patients with injection drug use -, administered at baseline (by day 7 at the latest). A decrease in the number of sessions may indicate an improvement.

Analyses will focus on within-participant change between baseline and Month 6, with intermediate assessments used to describe trajectories over follow-up.
From baseline (inclusion) to 6 months; assessed at Month 1 (M1), Month 3 (M3), Month 4 (M4), and Month 6 (M6)
Change in drug use practices : daily quantity consumed
Prazo: From baseline (inclusion) to 6 months; assessed at Month 1 (M1), Month 3 (M3), Month 4 (M4), and Month 6 (M6)

Evolution in Daily Quantity of Drug Consumed (grams/day), between baseline and 6 months (at M1, M3, M4, and M6), using the CANDITOX questionnaire (Assessment of the infectious risks related to intravenous drug use) -not validated, but routinely used in clinical practice for evaluating patients with injection drug use -, administered at baseline (by day 7 at the latest). A decrease in the number of sessions may indicate an improvement.

Analyses will focus on within-participant change between baseline and Month 6, with intermediate assessments used to describe trajectories over follow-up.
From baseline (inclusion) to 6 months; assessed at Month 1 (M1), Month 3 (M3), Month 4 (M4), and Month 6 (M6)
Change in the frequency and/or occurrence of drug-related complications
Prazo: From baseline (inclusion) to 6 months; assessed at Month 1 (M1), Month 3 (M3), Month 4 (M4), and Month 6 (M6)

Evolution of associated complications associated with drug use between baseline and 6 months (at M1, M3, M4, and M6), using the CANDITOX questionnaire ((Assessment of the infectious risks related to intravenous drug use) -not validated, but routinely used in clinical practice for evaluating patients with injection drug use -, administered at baseline (by day 7 at the latest).

A decrease in the total number of complications indicates an improvement.
From baseline (inclusion) to 6 months; assessed at Month 1 (M1), Month 3 (M3), Month 4 (M4), and Month 6 (M6)
Change in harm reduction knowledge and implementation score
Prazo: Month 1 (baseline for knowledge assessment), Month 3, and Month 6

Assessment of participants' knowledge and implementation of harm reduction strategies related to psychoactive substance use. Knowledge will be evaluated using a structured harm reduction questionnaire.

The primary metric will be the change in total knowledge score over time. Secondary analyses will assess the proportion of participants reporting implementation of harm reduction practices between assessments.
Month 1 (baseline for knowledge assessment), Month 3, and Month 6
Number of Declarations Submitted to the Regional Health Agency (ARS)
Prazo: From baseline (Day 0) to Month 6

Number of formal notifications and toxicological reports related to newly identified or atypical psychoactive substances generated by the study team during the 6-month study period.

Notifications are based on biological samples (urine, blood, hair) and/or powder analyses collected during the study and reported using the SINTES questionnaire framework.

The outcome will be reported as a cumulative count over the 6-month follow-up period.
From baseline (Day 0) to Month 6
Number of Addiction-Vigilance Notifications Transmitted to the French Addictovigilance Network (CEIP)
Prazo: From baseline (Day 0) to Month 6

Number of Addiction-Vigilance Notifications Transmitted to the French Addictovigilance generated by the study team during the 6-month study period.

Notifications are based on biological samples (urine, blood, hair) and/or powder analyses collected during the study and reported using the SINTES questionnaire framework.

The outcome will be reported as a cumulative count over the 6-month follow-up period.
From baseline (Day 0) to Month 6
Number of Analytical Results Transmitted to the OFDT
Prazo: From baseline (Day 0) to Month 6

Number of Analytical Results Transmitted to the French Monitoring Centre for Drugs and Drug Addiction (OFDT) specifically within the TREND-SINTES surveillance system (Île-de-France).

Notifications are based on biological samples (urine, blood, hair) and/or powder analyses collected during the study and reported using the SINTES questionnaire framework.

The outcome will be reported as a cumulative count over the 6-month follow-up period.
From baseline (Day 0) to Month 6

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Assistance Publique - Hôpitaux de Paris

Investigadores

  • Investigador principal: NGUYEN An Hung, Pitié Salpêtrière

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de outubro de 2026

Conclusão Primária (Estimado)

15 de outubro de 2029

Conclusão do estudo (Estimado)

15 de abril de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de julho de 2026

Primeira postagem (Real)

31 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

31 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • APHP210994

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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