Intensive Care Unit SyndromeADDICT-CCUNCT05063097

Addiction in Intensive Cardiac Care Units

An observational study of Intensive Care Unit Syndrome and Drug Abuse, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Background: Illicit drug use is a growing issue in Europe and leading cause of acute cardiac events in patients admitted to intensive cardiac care units. Indeed, cardiovascular complications are one of the main causes of death due to illicit drug use. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intensive Care Unit Syndrome, Drug Abuse, Substance-Related Disorders
What is being tested?: urine test, Fagerström questionnaire and Exhaled carbon monoxide (CO) measurement
Type of treatment: Injection or infusion
How many people: 1,500 participants
Where: 1 siteFrance
Study dates: 6 Apr 2021to Apr 2023
Phase: Observational
Are there results?: None posted in the registry

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

Study population: All consecutive patients over 18 years admitted to the CCU. The main exclusion criteria will be hospitalization for a planned interventional procedure, dementia, or hospitalization for more than 24 hours at any hospital facility before admission to the CCU. Informed consent will be obtained from all participants.

Who may be able to join

Patient over 18 years old admitted to Cardiac Intensive Care Unit (CCU) for any reason.
Oral informed consent.

Who cannot join

Hospitalization for a planned interventional procedure (percutaneous coronary intervention, coronary artery bypass graft surgery, transcatheter aortic valve implantation…).
Dementia.
Hospitalization for more than 24 hours at any hospital facility before admission to the CCU.
Patient under legal protection without the consent of the legal representative.
Patient with no social security.
Declining participation.

Trial locations and contacts

1 site in 1 country.

France1 site

CHU Lariboisière, APHP, Cardiology
Paris, Île-de-France Region, 75010

Other trials in France

About this study

Official title: Assessment of ADDICTion to Psychoactive Drug Use in Intensive Cardiac Care Units - The ADDICT-CCU Study

Background:

Illicit drug use is a growing issue in Europe and leading cause of acute cardiac events in patients admitted to intensive cardiac care units. Indeed, cardiovascular complications are one of the main causes of death due to illicit drug use. However, its prevalence in patients hospitalized in intensive cardiac care units is unknown.

Objectives:

This large multicenter prospective study will assess the prevalence of illicit drug use in consecutive patients hospitalized in intensive cardiac care units by urine drug assay.

Eligibility:

Patient over 18 years old admitted to intensive Cardiac Care Unit (CCU) for any reason.
Without hospitalization for a planned interventional procedure.
Without hospitalization for more than 24 hours at any hospital facility before admission to the CCU.

Design:

Multicentre cohort study with a prospective enrolment of all consecutive patients admitted to the CCU to assess the prevalence of illicit drug use in 40 centers throughout France.
Participants will be screened with a physical exam, medical history and addiction survey.
Participants will be screened for drug use by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) and for tobacco by standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK).
Participants will be followed at 6 months of follow-up to assess the occurrence of cardiovascular events.

Read the detailed description

Objective:

Illicit drug use is a growing issue in Europe. In France, the prevalence of the illicit use of any drug is 11.4% of the population, ahead of Italy (10.6%), the United Kingdom (8.7%) and Germany (7.8%).

Cardiovascular complications are one of the main causes of death due to psychoactive drug use with more than 100,000 deaths per year are due to psychoactive drug use in France. Although the use of illicit drugs may be involved in several acute cardiac events in patients admitted to intensive cardiac care units (CCU), its prevalence in patients hospitalized in CCU is unknown. Interestingly, the current guidelines recommend only a declarative survey to investigate psychoactive drug use but no systematic urine or plasma screening. However, the rate of underreporting of these illegal substances remains high. To our knowledge, no study has ever consecutively assessed the prevalence of psychoactive drug use using systematic urine or plasma screening at the time of CCU admission. Because illicit drug use is a potential cardiovascular risk factor, accurate drug screening may initiate addictology management, modify the treatment and improve patient prognosis after a cardiovascular event.

The aim of the prospective ADDICT-CCU study is to assess the prevalence of illicit drug use in consecutive patients hospitalized in intensive cardiac care units by urine drug assay.

Study population:

All consecutive patients over 18 years admitted to the CCU during a 3 week recruitment period in 40 centers. The main exclusion criteria will be hospitalization for a planned interventional procedure, dementia, or hospitalization for more than 24 hours at any hospital facility before admission to the CCU. Informed consent will be obtained from all participants.

Design:

The investigators will conduct a multicentre cohort study with a prospective enrolment of all consecutive patients admitted to the CCU to assess the prevalence of psychoactive drug use in 40 centers throughout France. Anonymized data supporting the findings of this study will be collected using CleanwebTM software.

Outcome Measures:

The primary outcome will be the prevalence of at least one illicit drug among all consecutive patients hospitalized in the CCU.

The following psychoactive drugs will be evaluated for all consecutive patients by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) within two hours of admission to the CCU: i) cannabinoids (tetrahydrocannabinol [THC]), including cannabis and hashish; ii) cocaine and metabolites, including cocaine and crack; iii) amphetamines; iv) MDMA; and v) heroin and other opioids.

In addition to the analysis of illicit drug use, the investigators will also use the NarcoCheck® urine drug assay to evaluate the associated use of the following psychoactive drugs: barbiturates, benzodiazepines, tricyclic antidepressant drugs, methadone and buprenorphine. Tobacco consumption will also be evaluated for each patient using a questionnaire with three choices: "never smoked," "smoking cessation" specifying the number of years, or "active smoking." Active smoking will also be systematically investigated in all patients using a standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK) on arrival, with a measure of > 3 parts per million (ppm) signifying active smoking. Every patient will be provided with relevant instructions regarding the urine drug assay and exhaled CO measurement, and trained investigators will conduct the tests.

Regarding the secondary outcomes, participants will be followed at 6 months of follow-up to assess the occurrence of cardiovascular events.

Conditions: Intensive Care Unit Syndrome, Drug Abuse, Substance-Related Disorders, Cardiovascular Events, Cardiac Disease
Being tested: urine test, Fagerström questionnaire, Exhaled carbon monoxide (CO) measurement
Keywords: Prevalence, Drug Abuse, Illicit drug use, Substance-Related Disorders, Intensive cardiac care unit, Cannabis, Cocaine, Cardiovascular events, Psychoactive drug use
Medical subject headings: Substance-Related Disorders, Heart Diseases, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

urine testOther
The following illicit drugs will be evaluated for all consecutive patients by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) within two hours of admission to the ICCU: i) cannabinoids (tetrahydrocannabinol [THC]), including cannabis and hashish; ii) cocaine and metabolites, including cocaine and crack; iii) amphetamines; iv) MDMA; and v) heroin and other opioids. In addition to the analysis of psychoactive drug use, the investigators will also use the NarcoCheck® urine drug assay to evaluate the associated use of the following psychostimulant drugs: barbiturates, benzodiazepines, tricyclic antidepressant drugs, methadone and buprenorphine.
Fagerström questionnaireOther
Tobacco consumption will also be evaluated for each patient using a Fagerström questionnaire.
Exhaled carbon monoxide (CO) measurementOther
Active smoking will also be systematically investigated in all patients using a standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK) on arrival, with a measure of > 3 parts per million (ppm) signifying active smoking.

Study groups in NCT05063097
Study group	Role	What they receive
CCU patients		All consecutive patients over 18 years admitted to the CCU. Receives: Other: urine test; Other: Fagerström questionnaire; Other: Exhaled carbon monoxide (CO) measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of psychoactive drug use assessed by urine drug assay at the time of patient admission.
The following psychoactive drugs will be evaluated for all consecutive patients by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) within two hours of admission to the CCU: i) cannabinoids (tetrahydrocannabinol [THC]), including cannabis and hashish; ii) cocaine and metabolites, including cocaine and crack; iii) amphetamines; iv) MDMA; and v) heroin and other opioids.
In addition to the analysis of psychoactive drug use, the investigators will also use the NarcoCheck® urine drug assay to evaluate the associated use of the following psychostimulant drugs: barbiturates, benzodiazepines, tricyclic antidepressant drugs, methadone and buprenorphine.
Measured: Day 0

Secondary outcomes (8)

In-hospital major adverse events (MAE)
In-hospital major adverse events (MAE) will be a combined outcome including:
- all-cause mortality,
- cardiogenic shock according to the European Society of Cardiology (ESC) guidelines, and requiring medical (catecholamines or inotropic agents) or mechanical haemodynamic support
- cardiac arrest: severe ventricular arrhytmia requiring defibrillation or anti-arrhytmic agents
This outcome will be assessed by the clinical team in charge of the CCU during the hospitalization.
Measured: Up to 3 months
Duration of the hospitalization
The duration of the hospitalization of each patient in CCU and in the hospital.
Measured: Up to 3 months
Combined major adverse clinical events (MACE).
MACE will be defined as all-cause death or unplanned hospitalization for acute cardiovascular reasons, confirmed by independent adjudication experts who will review medical documents according to the standardized definitions.
Measured: 12 months of follow-up
All cause mortality
The adjudication of all-cause death was performed using the electronic French National Registry of Death (Institut National de la Statistique et des Etudes Economiques, INSEE registry).
Measured: 12 months of follow-up
The occurrence of cardiovascular events
Other secondary outcomes will be assessed by independent adjudication experts will be as follows: all-cause death, cardiovascular mortality, nonfatal myocardial infarction, unstable angina, resuscitated cardiac arrest, hospitalizations for heart failure, heart transplantation or implantation of a mechanical circulatory support device, sustained ventricular arrhythmias, coronary revascularization, stroke, venous thromboembolic events, endocarditis and the implantation of a pacemaker or implantable cardioverter-defibrillator.
Measured: 12 months of follow-up
Combined major adverse clinical events (MACE).
MACE will be defined as all-cause death or unplanned hospitalization for acute
Measured: 24 months of follow-up
All cause mortality
The adjudication of all-cause death was performed using the electronic French National Registry of Death (Institut National de la Statistique et des Etudes Economiques, INSEE registry).
Measured: 24 months of follow-up
The occurrence of cardiovascular events
Other secondary outcomes will be assessed by independent adjudication experts will be as follows: all-cause death, cardiovascular mortality, nonfatal myocardial infarction, unstable angina, resuscitated cardiac arrest, hospitalizations for heart failure, heart transplantation or implantation of a mechanical circulatory support device, sustained ventricular arrhythmias, coronary revascularization, stroke, venous thromboembolic events, endocarditis and the implantation of a pacemaker or implantable cardioverter-defibrillator.
Measured: 24 months of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 2021Apr 2023

First posted30 Sep 2021
Study start6 Apr 2021
Primary completion6 Jun 2021
Study completionApr 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Intensive Care Unit SyndromeStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05063097
Sponsor's protocol ID: APHP190870
Other IDs: 2021-A00702-39
Acronym: ADDICT-CCU
Status last verified: Apr 2023
First submitted: 19 Jul 2021
Last updated: 18 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mirailles R, Delmas C, Toupin S, Bouleti C, Trimaille A, Schurtz G, Piliero N, Andrieu S, Lattuca B, Rossanaly Vasram R, Lim P, Noirclerc N, Goralski M, Deney A, Roubille F, Fauvel C, Bochaton T, Boccara F, Gerbaud E, Puymirat E, Vicaut E, Dillinger JG, Henry P, Pezel T; ADDICT-ICCU Investigators. Association Between Recreational Drug Use and Cardiovascular Events Post-Hospitalization in France. Circ Popul Health Outcomes. 2026 Feb;19(2):e011905. doi: 10.1161/CIRCOUTCOMES.124.011905. Epub 2026 Jan 13.
PubMed 41697269
Fauvel C, Dillinger JG, Bochaton T, Levasseur T, El Ouahidi A, Zakine C, El Hadad A, Mansencal N, Noirclerc N, Goralski M, Thuaire C, Mewton N, Schurtz G, Lim P, Pommier T, Lemarchand L, Laissac Q, Lamblin N, Boukertouta T, Logeart D, Cohen-Solal A, Henry P, Pezel T; ADDICT-ICCU Investigators. In-hospital and 1 year incremental prognostic value of drug abuse detection in acute heart failure. ESC Heart Fail. 2025 Aug;12(4):2736-2748. doi: 10.1002/ehf2.15118. Epub 2025 May 21.
PubMed 40396434
Weizman O, Hamzi K, Henry P, Schurtz G, Hauguel-Moreau M, Trimaille A, Bedossa M, Dib JC, Attou S, Boukertouta T, Boccara F, Pommier T, Lim P, Bochaton T, Millischer D, Merat B, Picard F, Grinberg N, Sulman D, Pasdeloup B, El Ouahidi Y, Goncalves T, Vicaut E, Dillinger JG, Toupin S, Pezel T; ADDICT-ICCU Investigators. Machine learning score to predict in-hospital outcomes in patients hospitalized in cardiac intensive care unit. Eur Heart J Digit Health. 2024 Dec 20;6(2):218-227. doi: 10.1093/ehjdh/ztae098. eCollection 2025 Mar.
PubMed 40110223
Sibilia B, Toupin S, Bouali N, Brette JB, Ramonatxo A, Schurtz G, Hamzi K, Trimaille A, Gall E, Piliero N, Unger A, Andrieu S, Goncalves T, Picard F, Roule V, Roubille F, Houssany-Pissot S, Bouchot O, Aboyans V, Vasram RR, Bochaton T, Logeart D, Solal AC, Cartailler J, Mebazaa A, Dillinger JG, Henry P, Pezel T. Supervised machine learning including environmental factors to predict in-hospital outcomes in acute heart failure patients. Eur Heart J Digit Health. 2024 Dec 16;6(2):190-199. doi: 10.1093/ehjdh/ztae094. eCollection 2025 Mar.
PubMed 40110211
Hamzi K, Gall E, Roubille F, Trimaille A, Elbaz M, El Ouahidi A, Noirclerc N, Fard D, Lattuca B, Fauvel C, Goralski M, Alvain S, Chaib A, Piliero N, Schurtz G, Pommier T, Bouleti C, Tron C, Bonnet G, Nhan P, Auvray S, Lequipar A, Dillinger JG, Vicaut E, Henry P, Toupin S, Pezel T; ADDICT-ICCU Investigators. Phenotypic clustering of patients hospitalized in intensive cardiac care units: Insights from the ADDICT-ICCU study. Arch Cardiovasc Dis. 2024 Jun-Jul;117(6-7):392-401. doi: 10.1016/j.acvd.2024.03.004. Epub 2024 May 23.
PubMed 38834393
Fauvel C, Dillinger JG, Bouleti C, Trimaille A, Tron C, Chaussade AS, Thuaire C, Delmas C, Boccara A, Roule V, Millischer D, Thevenet E, Meune C, Stevenard M, Charbonnel C, Maitre Ballesteros L, Pommier T, El Ouahidi A, Swedsky F, Martinez D, Hauguel-Moreau M, Schurtz G, Coisne A, Dupasquier V, Bochaton T, Gerbaud E, Puymirat E, Henry P, Pezel T; ADDICT-ICCU Investigators. Tricuspid annular plane systolic excursion over systolic pulmonary artery pressure prognostic value for in-hospital adverse events in patients hospitalized for acute coronary syndrome. Eur Heart J Cardiovasc Imaging. 2024 Aug 26;25(9):1244-1254. doi: 10.1093/ehjci/jeae110.
PubMed 38650518
Fauvel C, Dillinger JG, Rossanaly Vasram R, Bouleti C, Logeart D, Roubille F, Meune C, Ohlmann P, Bonnefoy-Coudraz E, Albert F, Attou S, Boukhris M, Pommier T, Merat B, Noirclerc N, Bouali N, Aghezzaf S, Schurtz G, Mansencal N, Andrieu S, Henry P, Pezel T; ADDICT-ICCU Investigators. In-hospital prognostic value of TAPSE/sPAP in patients hospitalized for acute heart failure. Eur Heart J Cardiovasc Imaging. 2024 Jul 31;25(8):1099-1108. doi: 10.1093/ehjci/jeae059.
PubMed 38428980
Clement A, Dillinger JG, Ramonatxo A, Roule V, Picard F, Thevenet E, Swedzky F, Hauguel-Moreau M, Sulman D, Stevenard M, Amri N, Martinez D, Maitre-Ballesteros L, Landemaine T, Coppens A, Bouali N, Guiraud-Chaumeil P, Gall E, Lequipar A, Henry P, Pezel T. In-hospital prognosis of acute ST-elevation myocardial infarction in patients with recent recreational drug use. Eur Heart J Acute Cardiovasc Care. 2024 May 7;13(4):324-332. doi: 10.1093/ehjacc/zuae024.
PubMed 38381068
Dillinger JG, Pezel T, Delmas C, Schurtz G, Trimaille A, Piliero N, Bouleti C, Lattuca B, Andrieu S, Fabre J, Rossanaly Vasram R, Dib JC, Aboyans V, Fauvel C, Roubille F, Gerbaud E, Boccara A, Puymirat E, Toupin S, Vicaut E, Henry P; ADDICT-ICCU trial. Carbon monoxide and prognosis in smokers hospitalised with acute cardiac events: a multicentre, prospective cohort study. EClinicalMedicine. 2024 Jan 3;67:102401. doi: 10.1016/j.eclinm.2023.102401. eCollection 2024 Jan.
PubMed 38261914
Pezel T, Dillinger JG, Trimaille A, Delmas C, Piliero N, Bouleti C, Pommier T, El Ouahidi A, Andrieu S, Lattuca B, Rossanaly Vasram R, Fard D, Noirclerc N, Bonnet G, Goralski M, Elbaz M, Deney A, Schurtz G, Docq C, Roubille F, Fauvel C, Bochaton T, Aboyans V, Boccara F, Puymirat E, Batisse A, Steg G, Vicaut E, Henry P; ADDICT-ICCU Investigators. Prevalence and impact of recreational drug use in patients with acute cardiovascular events. Heart. 2023 Oct 12;109(21):1608-1616. doi: 10.1136/heartjnl-2023-322520.
PubMed 37582633

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
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Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of ADDICTion to Psychoactive Drug Use in Intensive Cardiac Care Units - The ADDICT-CCU Study
ClinicalTrials.gov ID: NCT05063097
Acronym / sponsor ID: ADDICT-CCU / APHP190870
Conditions: Intensive Care Unit Syndrome, Drug Abuse, Substance-Related Disorders, Cardiovascular Events, Cardiac Disease
Keywords: Prevalence, Drug Abuse, Illicit drug use, Substance-Related Disorders, Intensive cardiac care unit, Cannabis, Cocaine, Cardiovascular events
Study type: Observational
Recruitment status: Unknown status
Enrolment: 1,500 participants (estimated)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Collaborators: Fondation Coeur et Recherche
Study start: 6 Apr 2021 (actual)
Primary completion: 6 Jun 2021 (actual)
Study completion: Apr 2023 (estimated)
First posted: 30 Sep 2021 (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.

Background:

Objectives:

This large multicenter prospective study will assess the prevalence of illicit drug use in consecutive patients hospitalized in intensive cardiac care units by urine drug assay.

Eligibility:

Patient over 18 years old admitted to intensive Cardiac Care Unit (CCU) for any reason.
Without hospitalization for a planned interventional procedure.
Without hospitalization for more than 24 hours at any hospital facility before admission to the CCU.

Design:

Multicentre cohort study with a prospective enrolment of all consecutive patients admitted to the CCU to assess the prevalence of illicit drug use in 40 centers throughout France.
Participants will be screened with a physical exam, medical history and addiction survey.
Participants will be screened for drug use by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) and for tobacco by standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK).
Participants will be followed at 6 months of follow-up to assess the occurrence of cardiovascular events.

Detailed description

Objective:

The aim of the prospective ADDICT-CCU study is to assess the prevalence of illicit drug use in consecutive patients hospitalized in intensive cardiac care units by urine drug assay.

Study population:

Design:

Outcome Measures:

The primary outcome will be the prevalence of at least one illicit drug among all consecutive patients hospitalized in the CCU.

Regarding the secondary outcomes, participants will be followed at 6 months of follow-up to assess the occurrence of cardiovascular events.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
CCU patients	–	Other: urine test, Other: Fagerström questionnaire, Other: Exhaled carbon monoxide (CO) measurementAll consecutive patients over 18 years admitted to the CCU.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All consecutive patients over 18 years admitted to the CCU. The main exclusion criteria will be hospitalization for a planned interventional procedure, dementia, or hospitalization for more than 24 hours at any hospital facility before admission to the CCU. Informed consent will be obtained from all participants.

Key inclusion criteria (2 listed)

Patient over 18 years old admitted to Cardiac Intensive Care Unit (CCU) for any reason.
Oral informed consent.

Key exclusion criteria (6 listed)

Hospitalization for a planned interventional procedure (percutaneous coronary intervention, coronary artery bypass graft surgery, transcatheter aortic valve implantation…).
Dementia.
Hospitalization for more than 24 hours at any hospital facility before admission to the CCU.
Patient under legal protection without the consent of the legal representative.
Patient with no social security.

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
urine testThe following illicit drugs will be evaluated for all consecutive patients by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) within two hours of admission to the ICCU: i) cannabinoids (tetrahydrocannabinol [THC]), including cannabis and hashish; ii) cocaine and metabolites, including cocaine and crack; iii) amphetamines; iv) MDMA; and v) heroin and other opioids. In addition to the analysis of psychoactive drug use, the investigators will also use the NarcoCheck® urine drug assay to evaluate the associated use of the following psychostimulant drugs: barbiturates, benzodiazepines, tricyclic antidepressant drugs, methadone and buprenorphine.	Other	CCU patients
Fagerström questionnaireTobacco consumption will also be evaluated for each patient using a Fagerström questionnaire.	Other	CCU patients
Exhaled carbon monoxide (CO) measurementActive smoking will also be systematically investigated in all patients using a standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK) on arrival, with a measure of > 3 parts per million (ppm) signifying active smoking.	Other	CCU patients

Primary outcome

Prevalence of psychoactive drug use assessed by urine drug assay at the time of patient admission.
Time frame: Day 0
The following psychoactive drugs will be evaluated for all consecutive patients by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) within two hours of admission to the CCU: i) cannabinoids (tetrahydrocannabinol [THC]), including cannabis and hashish; ii) cocaine and metabolites, including cocaine and crack; iii) amphetamines; iv) MDMA; and v) heroin and other opioids. In addition to the analysis of psychoactive drug use, the investigators will also use the NarcoCheck® urine drug assay to evaluate the associated use of the following psychostimulant drugs: barbiturates, benzodiazepines, tricyclic antidepressant drugs, methadone and buprenorphine.

8 secondary outcomes

In-hospital major adverse events (MAE)
Time frame: Up to 3 months
Duration of the hospitalization
Time frame: Up to 3 months
Combined major adverse clinical events (MACE).
Time frame: 12 months of follow-up
All cause mortality
Time frame: 12 months of follow-up
The occurrence of cardiovascular events
Time frame: 12 months of follow-up
Combined major adverse clinical events (MACE).
Time frame: 24 months of follow-up
All cause mortality
Time frame: 24 months of follow-up
The occurrence of cardiovascular events
Time frame: 24 months of follow-up

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
Derived from this study: PubMed 41697269Mirailles R, Delmas C, Toupin S, Bouleti C, Trimaille A, Schurtz G, Piliero N, Andrieu S, Lattuca B, Rossanaly Vasram R, Lim P, Noirclerc N, Goralski M, Deney A, Roubille F, Fauvel C, Bochaton T, Boccara F, Gerbaud E, Puymirat E, Vicaut E, Dillinger JG, Henry P, Pezel T; ADDICT-ICCU Investigators. Association Between Recreational Drug Use and Cardiovascular Events Post-Hospitalization in France. Circ Popul Health Outcomes. 2026 Feb;19(2):e011905. doi: 10.1161/CIRCOUTCOMES.124.011905. Epub 2026 Jan 13.
Derived from this study: PubMed 40396434Fauvel C, Dillinger JG, Bochaton T, Levasseur T, El Ouahidi A, Zakine C, El Hadad A, Mansencal N, Noirclerc N, Goralski M, Thuaire C, Mewton N, Schurtz G, Lim P, Pommier T, Lemarchand L, Laissac Q, Lamblin N, Boukertouta T, Logeart D, Cohen-Solal A, Henry P, Pezel T; ADDICT-ICCU Investigators. In-hospital and 1 year incremental prognostic value of drug abuse detection in acute heart failure. ESC Heart Fail. 2025 Aug;12(4):2736-2748. doi: 10.1002/ehf2.15118. Epub 2025 May 21.
Derived from this study: PubMed 40110223Weizman O, Hamzi K, Henry P, Schurtz G, Hauguel-Moreau M, Trimaille A, Bedossa M, Dib JC, Attou S, Boukertouta T, Boccara F, Pommier T, Lim P, Bochaton T, Millischer D, Merat B, Picard F, Grinberg N, Sulman D, Pasdeloup B, El Ouahidi Y, Goncalves T, Vicaut E, Dillinger JG, Toupin S, Pezel T; ADDICT-ICCU Investigators. Machine learning score to predict in-hospital outcomes in patients hospitalized in cardiac intensive care unit. Eur Heart J Digit Health. 2024 Dec 20;6(2):218-227. doi: 10.1093/ehjdh/ztae098. eCollection 2025 Mar.
Derived from this study: PubMed 40110211Sibilia B, Toupin S, Bouali N, Brette JB, Ramonatxo A, Schurtz G, Hamzi K, Trimaille A, Gall E, Piliero N, Unger A, Andrieu S, Goncalves T, Picard F, Roule V, Roubille F, Houssany-Pissot S, Bouchot O, Aboyans V, Vasram RR, Bochaton T, Logeart D, Solal AC, Cartailler J, Mebazaa A, Dillinger JG, Henry P, Pezel T. Supervised machine learning including environmental factors to predict in-hospital outcomes in acute heart failure patients. Eur Heart J Digit Health. 2024 Dec 16;6(2):190-199. doi: 10.1093/ehjdh/ztae094. eCollection 2025 Mar.
Derived from this study: PubMed 38834393Hamzi K, Gall E, Roubille F, Trimaille A, Elbaz M, El Ouahidi A, Noirclerc N, Fard D, Lattuca B, Fauvel C, Goralski M, Alvain S, Chaib A, Piliero N, Schurtz G, Pommier T, Bouleti C, Tron C, Bonnet G, Nhan P, Auvray S, Lequipar A, Dillinger JG, Vicaut E, Henry P, Toupin S, Pezel T; ADDICT-ICCU Investigators. Phenotypic clustering of patients hospitalized in intensive cardiac care units: Insights from the ADDICT-ICCU study. Arch Cardiovasc Dis. 2024 Jun-Jul;117(6-7):392-401. doi: 10.1016/j.acvd.2024.03.004. Epub 2024 May 23.
Derived from this study: PubMed 38650518Fauvel C, Dillinger JG, Bouleti C, Trimaille A, Tron C, Chaussade AS, Thuaire C, Delmas C, Boccara A, Roule V, Millischer D, Thevenet E, Meune C, Stevenard M, Charbonnel C, Maitre Ballesteros L, Pommier T, El Ouahidi A, Swedsky F, Martinez D, Hauguel-Moreau M, Schurtz G, Coisne A, Dupasquier V, Bochaton T, Gerbaud E, Puymirat E, Henry P, Pezel T; ADDICT-ICCU Investigators. Tricuspid annular plane systolic excursion over systolic pulmonary artery pressure prognostic value for in-hospital adverse events in patients hospitalized for acute coronary syndrome. Eur Heart J Cardiovasc Imaging. 2024 Aug 26;25(9):1244-1254. doi: 10.1093/ehjci/jeae110.
Derived from this study: PubMed 38428980Fauvel C, Dillinger JG, Rossanaly Vasram R, Bouleti C, Logeart D, Roubille F, Meune C, Ohlmann P, Bonnefoy-Coudraz E, Albert F, Attou S, Boukhris M, Pommier T, Merat B, Noirclerc N, Bouali N, Aghezzaf S, Schurtz G, Mansencal N, Andrieu S, Henry P, Pezel T; ADDICT-ICCU Investigators. In-hospital prognostic value of TAPSE/sPAP in patients hospitalized for acute heart failure. Eur Heart J Cardiovasc Imaging. 2024 Jul 31;25(8):1099-1108. doi: 10.1093/ehjci/jeae059.
Derived from this study: PubMed 38381068Clement A, Dillinger JG, Ramonatxo A, Roule V, Picard F, Thevenet E, Swedzky F, Hauguel-Moreau M, Sulman D, Stevenard M, Amri N, Martinez D, Maitre-Ballesteros L, Landemaine T, Coppens A, Bouali N, Guiraud-Chaumeil P, Gall E, Lequipar A, Henry P, Pezel T. In-hospital prognosis of acute ST-elevation myocardial infarction in patients with recent recreational drug use. Eur Heart J Acute Cardiovasc Care. 2024 May 7;13(4):324-332. doi: 10.1093/ehjacc/zuae024.
Derived from this study: PubMed 38261914Dillinger JG, Pezel T, Delmas C, Schurtz G, Trimaille A, Piliero N, Bouleti C, Lattuca B, Andrieu S, Fabre J, Rossanaly Vasram R, Dib JC, Aboyans V, Fauvel C, Roubille F, Gerbaud E, Boccara A, Puymirat E, Toupin S, Vicaut E, Henry P; ADDICT-ICCU trial. Carbon monoxide and prognosis in smokers hospitalised with acute cardiac events: a multicentre, prospective cohort study. EClinicalMedicine. 2024 Jan 3;67:102401. doi: 10.1016/j.eclinm.2023.102401. eCollection 2024 Jan.
Derived from this study: PubMed 37582633Pezel T, Dillinger JG, Trimaille A, Delmas C, Piliero N, Bouleti C, Pommier T, El Ouahidi A, Andrieu S, Lattuca B, Rossanaly Vasram R, Fard D, Noirclerc N, Bonnet G, Goralski M, Elbaz M, Deney A, Schurtz G, Docq C, Roubille F, Fauvel C, Bochaton T, Aboyans V, Boccara F, Puymirat E, Batisse A, Steg G, Vicaut E, Henry P; ADDICT-ICCU Investigators. Prevalence and impact of recreational drug use in patients with acute cardiovascular events. Heart. 2023 Oct 12;109(21):1608-1616. doi: 10.1136/heartjnl-2023-322520.
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. This study is not recruiting at the moment.

Jean-Guillaume DILLINGER, MD,PhD study director

Lariboisière Hospital, APHP, Paris

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Intensive Care Unit Syndrome and Drug Abuse, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of psychoactive drug use assessed by urine drug assay at the time of patient admission. (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05063097, which also lists 10 linked publications.

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 18 Apr 2023.