Intoxication; OpioidIPAISNCT07738835
Early Addiction Care Pathway After Acute Drug Intoxication in Emergency Departments
A study testing Structured early addiction care and Not structured early addiction care in people with Intoxication; Opioid, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intoxication; Opioid
- What is being tested?
- Structured early addiction care and Not structured early addiction care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Oct 2026to 15 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Hôpital Saint Antoine
Paris, 75012
PANIZZI Vincent, MD, vincent.panizzi@aphp.fr
Unité d'Addictologie Hospitalière/ELSA Hôpital Pitié Salpêtrière
Paris, 75013
NGUYEN An Hung, MD, 01 42 17 85 16, an-hung.nguyen@aphp.fr
Hôpital Tenon
Paris, 75020
hôpital kremlin Bicêtre
Paris
SAUNIER Marc, MD, eric.saunier@aphp.fr
About this study
Official title: 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).
Read more
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.
Read the detailed description
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.
- Conditions
- Intoxication; Opioid
- Being tested
- Structured early addiction care, Not structured early addiction care
- Keywords
- psychoactive substances, Intoxications aiguës, Stupéfiants, acute intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured early addiction careBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Not structured early addiction care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization
Secondary outcomes (12)
Rate of recurrent acute intoxication episodes.
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.
Measured: 3 months and 6 months after randomization
Change in Anxiety and depression score
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).
Measured: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in health-related quality score
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)
Measured: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in severity of sleep disorders score
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.
Measured: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in Need for thrills score
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.
Measured: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in drug use practices : weekly Number of Drug Use Sessions
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Month 1 (baseline for knowledge assessment), Month 3, and Month 6
Number of Declarations Submitted to the Regional Health Agency (ARS)
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.
Measured: From baseline (Day 0) to Month 6
Number of Addiction-Vigilance Notifications Transmitted to the French Addictovigilance Network (CEIP)
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.
Measured: From baseline (Day 0) to Month 6
Number of Analytical Results Transmitted to the OFDT
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.
Measured: From baseline (Day 0) to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2029 (estimated)
- Study completion15 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intoxication; OpioidStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NGUYEN An Hung, Principal investigator, Pitié Salpétrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738835
- Sponsor's protocol ID
- APHP210994
- Acronym
- IPAIS
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions Précoces en Addictologie Dans le Cadre Des Urgences Par Intoxications aiguës Aux Stupéfiants (IPAIS)
- ClinicalTrials.gov ID
- NCT07738835
- Acronym / sponsor ID
- IPAIS / APHP210994
- Conditions
- Intoxication; Opioid
- Keywords
- psychoactive substances, Intoxications aiguës, Stupéfiants, acute intoxication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2029 (estimated)
- Study completion
- 15 Apr 2030 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured early addiction care | Experimental | Behavioral: Structured early addiction careParticipants 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. |
| Not structured early addiction care | Other | Behavioral: Not structured early addiction careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured early addiction careThe 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. | Behavioural | Structured early addiction care |
| Not structured early addiction careThe 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. | Behavioural | Not structured early addiction care |
Primary outcome
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.
12 secondary outcomes
Rate of recurrent acute intoxication episodes.
Time frame: 3 months and 6 months after randomization
Change in Anxiety and depression score
Time frame: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in health-related quality score
Time frame: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in severity of sleep disorders score
Time frame: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
Change in Need for thrills score
Time frame: Randomisation (Day 7) and Month 1; relapse assessed up to 6 months
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)
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)
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)
Change in harm reduction knowledge and implementation score
Time frame: Month 1 (baseline for knowledge assessment), Month 3, and Month 6
Number of Declarations Submitted to the Regional Health Agency (ARS)
Time frame: From baseline (Day 0) to Month 6
Number of Addiction-Vigilance Notifications Transmitted to the French Addictovigilance Network (CEIP)
Time frame: From baseline (Day 0) to Month 6
Number of Analytical Results Transmitted to the OFDT
Time frame: From baseline (Day 0) to Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NGUYEN An Hung principal investigator
Pitié Salpétrière
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured early addiction care and Not structured early addiction care in people with Intoxication; Opioid, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BISSERY Anne (0 1 42 16 24 32, anne.bissery@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in addiction care at 6 months (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.