Early Addiction Care Pathway After Acute Drug Intoxication in Emergency Departments

NCT07738835 | Not Yet Recruiting

• 1 other identifier: APHP210994
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Intoxication; Opioid

Keywords

psychoactive substances; Intoxications aiguës; Stupéfiants; acute intoxication

Outcome Measures

Primary Outcomes (1)

• Retention in addiction care at 6 months

  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

Secondary Outcomes (12)

• Rate of recurrent acute intoxication episodes.

  3 months and 6 months after randomization

• Change in Anxiety and depression score

  Randomisation (Day 7) and Month 1; relapse assessed up to 6 months

• Change in health-related quality score

  Randomisation (Day 7) and Month 1; relapse assessed up to 6 months

• Change in severity of sleep disorders score

  Randomisation (Day 7) and Month 1; relapse assessed up to 6 months

• Change in Need for thrills score

  Randomisation (Day 7) and Month 1; relapse assessed up to 6 months

Study Arms (2)

Structured early addiction care

EXPERIMENTAL

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.

Behavioral: Structured early addiction care

Not structured early addiction care

OTHER

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.

Behavioral: Not structured early addiction care

Interventions

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.

Structured early 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.

Not structured early addiction care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Have a mobile phone number or email address to be contacted

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (4)

Hôpital Saint Antoine

Paris, 75012, France

Location

Unité d'Addictologie Hospitalière/ELSA Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital Tenon

Paris, 75020, France

Location

hôpital kremlin Bicêtre

Paris, France

Location

Study Officials

• NGUYEN An Hung

  Pitié Salpétrière

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BISSERY Anne

CONTACT

0 1 42 16 24 32; anne.bissery@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2029
• Study Completion (Estimated): April 15, 2030
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)