IntoxicationNCT07819500
Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care
A study testing Preventox, a digital self-help tool for patients with intoxications in intensive care. in people with Intoxication and Delirium Tremens (DTs), run by Karolinska Institutet.
Trial summary
Background and purpose At present, occasional referral to psychiatric or addiction services is the only aftercare option offered following an intoxication/overdose requiring intensive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intoxication, Delirium Tremens (DTs), Poisoning by Psychoactive Substances
- What is being tested?
- Preventox, a digital self-help tool for patients with intoxications in intensive care.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 1 Jun 2028
- 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 aged =>18 years; treated at the IMA/MIVA units at Södersjukhuset, during a defined period; assigned a discharge code according to ICD-10 relating to unintentional or intentional poisoning by intoxicants (F10.0-F17.0, F19.0), or a discharge code according to ICD-10 relating to alcohol-induced withdrawal with delirium (F10.4), or treated for seizures related to alcohol or benzodiazepine withdrawal; Swedish- or English-speaking.
Who cannot join
- Patients without a Swedish personal identity number.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preventox - a Digital Self-help Tool for Patients With Intoxications in Intensive Care
Background and purpose At present, occasional referral to psychiatric or addiction services is the only aftercare option offered following an intoxication/overdose requiring intensive care. The investigators intend to test whether a new self-help tool can serve as a complement to this, and are now conducting a pilot study to determine whether the application could help prevent further severe intoxications/overdoses. The research principals for the project - ie the responsible organizations, are Region Stockholm and Karolinska Institutet. The research has been approved by the Swedish Ethical Review Authority; the reference number for the review is 2025-03529-01.
How is the study conducted? You will receive a brochure/card with information and access to the self-help tool called Preventox. Preventox is a website where you can create a personal login and set goals, keep an alcohol/substance diary, identify high-risk situations, create a crisis plan, learn about cravings, and obtain information on where to turn if you need support. No one other than you and the participating researchers can see what you record under your login. A reminder will be sent via 1177.
Read more
After 12 months, the investigators will use registry data to determine whether you have received care for a further intoxication/overdose. Only participating researchers will have access to this information, which will subsequently be de-identified.
Data handling and confidentiality Use of the service is entirely personal, i.e. only you have access to your login and the information you record there. Registry data will be processed confidentially and thereafter de-identified, so that no unauthorised person can access your information. Medical record review may be carried out to validate procedures. The results of the study will be presented at group level. Responsible for your personal data are the Emergency Hospitals Board, Region Stockholm, and Karolinska Institutet. Data will be stored in accordance with the recommendations of Karolinska Institutet and Section 3 of the Swedish Archives Act (1990:782).
Under the EU General Data Protection Regulation, you have the right to obtain, free of charge, access to the information about you that is processed within the project, and to have any errors corrected. You may also request that information about you will be erased and that the processing of your personal data will be restricted. If you wish to access the information, please contact the responsible researcher listed below.
The Data Protection Officers can be reached by email at: dataskydd.sodersjukhuset@regionstockholm.se and dataskyddsombud@ki.se.
Information about the study results and questions If you wish, the results can be shared with you on request. If you have any other questions, you are welcome to contact the persons listed below.
Voluntary participation Participation is entirely voluntary. You may discontinue your participation in the study at any time, without explanation and without giving any reason, and without this affecting your other care and treatment. If you wish to do so, please contact one of the contact persons listed below.
Read the detailed description
Preventox is an internet-based self-help tool developed by The Stockholm Centre for Dependency Disorders together with the medical intensive care unit Södersjukhuset. In-depth interviews with patients who have received intensive care for intoxications have been conducted prior to study commencement, in order to provide a basis for modifying the application so that it better corresponds to the intensive care context and to the patient group concerned.
Aim To determine whether a larger randomised controlled trial (RCT) would be feasible in practice, and to evaluate whether the self-help tool Preventox could contribute to reduced mortality and to a reduction in readmissions and emergency department visits within somatic acute care related to alcohol and illicit drug use.
Methods A two-arm randomised controlled pragmatic pilot/feasibility study in patients treated in an intensive care unit or intermediate care unit in Stockholm for intoxication with alcohol or illicit drugs, withdrawal seizures, or delirium tremens. A power calculation for the intervention study conducted as a full RCT indicated that approximately 300 patients per arm would be required to demonstrate a 10% reduction in the readmission rate. The present study is instead planned as an exploratory feasibility study, with patients recruited over a limited period of approximately one year.
Recruitment and randomisation take place once the patient is somatically ready for discharge from intensive or intermediate care, immediately prior to discharge. All patients receive information about the study, and consent is obtained. Participants are thereafter enrolled and randomised, either to the intervention arm with access to Preventox or to standard discharge procedures. Patient recruitment takes place during a predefined period. All patients are followed up after 12 months with respect to readmission, emergency department visits within somatic acute care, and death at 1, 3 and 12 months after the index admission.
Outcome measures: the primary outcomes are readmissions and emergency department visits within somatic acute care at 1, 3 and 12 months after the index admission, related to intoxication with alcohol and/or illicit drugs, withdrawal seizures, or delirium tremens. The secondary outcome is mortality at 1, 3 and 12 months after the admission.
The feasibility of the study will be analysed descriptively on the basis of the feasibility measures of acceptability, recruitment and resources, together with preliminary outcomes. The purpose is to test the entire study procedure ahead of a full-scale RCT.
- Conditions
- Intoxication, Delirium Tremens (DTs), Poisoning by Psychoactive Substances, Suicidal Attempt
- Being tested
- Preventox, a digital self-help tool for patients with intoxications in intensive care., Preventox control group
- Keywords
- Intoxication, Self-poisoning, self-help tool
- Medical subject headings
- Alcohol Withdrawal Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventox, a digital self-help tool for patients with intoxications in intensive care.Other
The intervention consists of a digital self-help tool that patients get access to at discharge from the ICU. All patients are followed up after 12 months via the National Patient Register, the Swedish Intensive Care Registry and the Cause of Death Register with respect to readmission, emergency department visits within somatic acute care, and death at 1, 3 and 12 months after the index admission.
Preventox control groupOther
Standard procedures at discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | The patients in the intervention arm gets access to a new digital self-help tool at discharge from the ICU. Receives: Other: Preventox, a digital self-help tool for patients with intoxications in intensive care. |
| Control arm | Active comparator | Standard procedures at discharge. Receives: Other: Preventox control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission
Readmissions and emergency department visits within somatic acute care at 1, 3 and 12 months after the index admission, related to intoxication with alcohol and/or illicit drugs, withdrawal seizures, or delirium tremens.
Measured: 1,3 and 12 months post discharge.
Secondary outcomes (1)
Mortality
Mortality at 1, 3 and 12 months after the index admission.
Measured: 1, 3 and 12 months post discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntoxicationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Model description
- Exploratory feasibility study as a RCT.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Märit Halmin, Karolinska Institutet
- Investigators
- Märit Halmin, MD, PhD, Principal investigator, Karolinska Instiutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819500
- Sponsor's protocol ID
- 2025-03529-01
- Other IDs
- 2025
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 23 Sep 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventox - a Digital Self-help Tool for Patients With Intoxications in Intensive Care
- ClinicalTrials.gov ID
- NCT07819500
- Acronym / sponsor ID
- 2025-03529-01
- Conditions
- Intoxication, Delirium Tremens (DTs), Poisoning by Psychoactive Substances, Suicidal Attempt
- Keywords
- Intoxication, Self-poisoning, self-help tool
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 15 Sep 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.
Background and purpose At present, occasional referral to psychiatric or addiction services is the only aftercare option offered following an intoxication/overdose requiring intensive care. The investigators intend to test whether a new self-help tool can serve as a complement to this, and are now conducting a pilot study to determine whether the application could help prevent further severe intoxications/overdoses. The research principals for the project - ie the responsible organizations, are Region Stockholm and Karolinska Institutet. The research has been approved by the Swedish Ethical Review Authority; the reference number for the review is 2025-03529-01.
How is the study conducted? You will receive a brochure/card with information and access to the self-help tool called Preventox. Preventox is a website where you can create a personal login and set goals, keep an alcohol/substance diary, identify high-risk situations, create a crisis plan, learn about cravings, and obtain information on where to turn if you need support. No one other than you and the participating researchers can see what you record under your login. A reminder will be sent via 1177.
After 12 months, the investigators will use registry data to determine whether you have received care for a further intoxication/overdose. Only participating researchers will have access to this information, which will subsequently be de-identified.
Data handling and confidentiality Use of the service is entirely personal, i.e. only you have access to your login and the information you record there. Registry data will be processed confidentially and thereafter de-identified, so that no unauthorised person can access your information. Medical record review may be carried out to validate procedures. The results of the study will be presented at group level. Responsible for your personal data are the Emergency Hospitals Board, Region Stockholm, and Karolinska Institutet. Data will be stored in accordance with the recommendations of Karolinska Institutet and Section 3 of the Swedish Archives Act (1990:782).
Under the EU General Data Protection Regulation, you have the right to obtain, free of charge, access to the information about you that is processed within the project, and to have any errors corrected. You may also request that information about you will be erased and that the processing of your personal data will be restricted. If you wish to access the information, please contact the responsible researcher listed below.
The Data Protection Officers can be reached by email at: dataskydd.sodersjukhuset@regionstockholm.se and dataskyddsombud@ki.se.
Information about the study results and questions If you wish, the results can be shared with you on request. If you have any other questions, you are welcome to contact the persons listed below.
Voluntary participation Participation is entirely voluntary. You may discontinue your participation in the study at any time, without explanation and without giving any reason, and without this affecting your other care and treatment. If you wish to do so, please contact one of the contact persons listed below.
Detailed description
Preventox is an internet-based self-help tool developed by The Stockholm Centre for Dependency Disorders together with the medical intensive care unit Södersjukhuset. In-depth interviews with patients who have received intensive care for intoxications have been conducted prior to study commencement, in order to provide a basis for modifying the application so that it better corresponds to the intensive care context and to the patient group concerned.
Aim To determine whether a larger randomised controlled trial (RCT) would be feasible in practice, and to evaluate whether the self-help tool Preventox could contribute to reduced mortality and to a reduction in readmissions and emergency department visits within somatic acute care related to alcohol and illicit drug use.
Methods A two-arm randomised controlled pragmatic pilot/feasibility study in patients treated in an intensive care unit or intermediate care unit in Stockholm for intoxication with alcohol or illicit drugs, withdrawal seizures, or delirium tremens. A power calculation for the intervention study conducted as a full RCT indicated that approximately 300 patients per arm would be required to demonstrate a 10% reduction in the readmission rate. The present study is instead planned as an exploratory feasibility study, with patients recruited over a limited period of approximately one year.
Recruitment and randomisation take place once the patient is somatically ready for discharge from intensive or intermediate care, immediately prior to discharge. All patients receive information about the study, and consent is obtained. Participants are thereafter enrolled and randomised, either to the intervention arm with access to Preventox or to standard discharge procedures. Patient recruitment takes place during a predefined period. All patients are followed up after 12 months with respect to readmission, emergency department visits within somatic acute care, and death at 1, 3 and 12 months after the index admission.
Outcome measures: the primary outcomes are readmissions and emergency department visits within somatic acute care at 1, 3 and 12 months after the index admission, related to intoxication with alcohol and/or illicit drugs, withdrawal seizures, or delirium tremens. The secondary outcome is mortality at 1, 3 and 12 months after the admission.
The feasibility of the study will be analysed descriptively on the basis of the feasibility measures of acceptability, recruitment and resources, together with preliminary outcomes. The purpose is to test the entire study procedure ahead of a full-scale RCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exploratory feasibility study as a RCT.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Preventox, a digital self-help tool for patients with intoxications in intensive care.The patients in the intervention arm gets access to a new digital self-help tool at discharge from the ICU. |
| Control arm | Active comparator | Other: Preventox control groupStandard procedures at discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged =>18 years; treated at the IMA/MIVA units at Södersjukhuset, during a defined period; assigned a discharge code according to ICD-10 relating to unintentional or intentional poisoning by intoxicants (F10.0-F17.0, F19.0), or a discharge code according to ICD-10 relating to alcohol-induced withdrawal with delirium (F10.4), or treated for seizures related to alcohol or benzodiazepine withdrawal; Swedish- or English-speaking.
Key exclusion criteria (1 listed)
- Patients without a Swedish personal identity number.
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 |
|---|---|---|
| Preventox, a digital self-help tool for patients with intoxications in intensive care.The intervention consists of a digital self-help tool that patients get access to at discharge from the ICU. All patients are followed up after 12 months via the National Patient Register, the Swedish Intensive Care Registry and the Cause of Death Register with respect to readmission, emergency department visits within somatic acute care, and death at 1, 3 and 12 months after the index admission. | Other | Intervention arm |
| Preventox control groupStandard procedures at discharge. | Other | Control arm |
Primary outcome
Readmission
Time frame: 1,3 and 12 months post discharge.
Readmissions and emergency department visits within somatic acute care at 1, 3 and 12 months after the index admission, related to intoxication with alcohol and/or illicit drugs, withdrawal seizures, or delirium tremens.
1 secondary outcome
Mortality
Time frame: 1, 3 and 12 months post discharge.
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 23 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Intoxication
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
RecruitingPhase 2
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Methamphetamine Intoxication, Methamphetamine Disorders
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.
Märit Halmin, MD, PhD principal investigator
Karolinska Instiutet
Questions about this trial
What is this clinical trial studying?
A study testing Preventox, a digital self-help tool for patients with intoxications in intensive care. in people with Intoxication and Delirium Tremens (DTs), run by Karolinska Institutet.
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 1 inclusion and 1 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ellinor Larsen, PhD student (0046708953208, ellinor.larsen@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission (time frame: 1,3 and 12 months post discharge.). 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 23 Sep 2026.