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

27 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

266

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Övrig: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Retention in addiction care at 6 months
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of recurrent acute intoxication episodes.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Assistance Publique - Hôpitaux de Paris

Utredare

  • Huvudutredare: NGUYEN An Hung, Pitié Salpêtrière

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 oktober 2026

Primärt slutförande (Beräknad)

15 oktober 2029

Avslutad studie (Beräknad)

15 april 2030

Studieregistreringsdatum

Först inskickad

8 juni 2026

Först inskickad som uppfyllde QC-kriterierna

27 juli 2026

Första postat (Faktisk)

31 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • APHP210994

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