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NCT Number: NCT07738835

Early Addiction Care Pathway After Acute Drug Intoxication in Emergency Departments

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.

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Key information

Conditions

Intoxication; Opioid

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint Antoine, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured early addiction care

Behavioral

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.

Not structured early addiction care

Behavioral

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.

Primary outcomes

  1. Retention in addiction care at 6 months

    Time frame: 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.

Secondary outcomes

  1. Rate of recurrent acute intoxication episodes.

    Time frame: 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.

  2. Change in Anxiety and depression score

    Time frame: 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).

  3. Change in health-related quality score

    Time frame: 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)

  4. Change in severity of sleep disorders score

    Time frame: 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.

  5. Change in Need for thrills score

    Time frame: 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.

  6. Change in drug use practices : weekly Number of Drug Use Sessions

    Time frame: 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.

  7. Change in drug use practices : daily quantity consumed

    Time frame: 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.

  8. Change in the frequency and/or occurrence of drug-related complications

    Time frame: 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.

  9. Change in harm reduction knowledge and implementation score

    Time frame: 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.

  10. Number of Declarations Submitted to the Regional Health Agency (ARS)

    Time frame: 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.

  11. Number of Addiction-Vigilance Notifications Transmitted to the French Addictovigilance Network (CEIP)

    Time frame: 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.

  12. Number of Analytical Results Transmitted to the OFDT

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

BISSERY Anne

CONTACT

[email protected]

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Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: IPAIS

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.