AddictologyAPREVIONCT05536245
Analysis of the Prevalence of Violence Suffered or Committed by Patients Suffering From Addiction in a Care Facility
An observational study of Addictology, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial summary
Addictions, whether to a substance or a behavior, are often associated with violence, but their role is not well known. Despite the publication of numerous studies demonstrating the influence of addictions in acts of violence, the exploration of violence in the context of addiction remains very limited. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Addictology
- What is being tested?
- Questionnaire
- How many people
- 4,500 participants
- Where
- 4 sitesFrance
- Study dates
- 14 Jan 2022to 6 Mar 2024
- 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 to 99 years
- All sexes
- Adult, Older adult
Study population: patients (stabilized out of crisis or under the influence of substances), men or women over 18 years of age who are able to understand the information letter and the questionnaire and to express their non-opposition. These patients must be under the care of an Addictology structure for addictive behavior, misuse of narcotics or for the consolidation of a sobriety
Who may be able to join
- Outpatient under care in an Addictology structure.
- Male or female patient over 18 years old.
- Outpatient able to express his/her non-opposition.
Who cannot join
- Patient consulting for the first time. Patient under court protection, guardianship or curatorship. Severe psychiatric disorders that have not been stabilized: (schizophrenia, bipolar disorders, etc.).
- Severe neurological disorders that are incompatible with reliable data collection.
- Minor patients. Pregnant women, parturients. People in emergency situations, people unable to express their consent.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Gaëlle SULTAN-TIHLL
Béziers, 34525
Hélène DONNADIEU
Montpellier, 34295
Pascal PERNEY
Nîmes, 30029
Nicolas FRANCHITTO
Toulouse, 31059
About this study
Addictions, whether to a substance or a behavior, are often associated with violence, but their role is not well known. Despite the publication of numerous studies demonstrating the influence of addictions in acts of violence, the exploration of violence in the context of addiction remains very limited. In order to fill this gap, teams members of the Addictopôle Occitanie in collaboration with a regional team are preparing the launch of a concrete longitudinal study to analyze the incidence of violence in populations suffering from addiction, but also to evaluate the need in terms of management of this violence.
Hypotheses: To analyze the prevalence of violence in populations suffering from addiction and the need for treatment of such violence using a robust protocol based on an anonymous questionnaire to assess the violence experienced or committed by a patient, taking into account his/her environment. This study would allow us to better understand the effects of addictions on the severity and frequency of violence, but also to implement concrete and adapted solutions in order to limit it. This study could lead to the creation of a regional Observatory of Violence related to Addictions.
Translated with www.DeepL.com/Translator (free version)
Read the detailed description
Study visits will be conducted in the following chronological order:
- Inclusion/End Visit (IEV): D0.Eligible patients will have been identified by the investigator, and will be recruited in the Addictology Department during their usual visit.
The inclusion visit is carried out by an investigating physician who will confirm the patient's eligibility and verify his or her ability to answer the questionnaire. It will take place in the care center. It is part of the usual care.
During this visit, the investigator will:
- Perform the usual management of the patient.
- Validate the inclusion and non-inclusion criteria.
- Issue the letter of information and non-opposition ii. Self-questionnaire entry visit (Vfollow-up/end): from D0 to 18 months (part of the usual care). After inclusion, the subject has enough time (15-30 min) to fill in the questionnaire independently. If the subject asks for it, the doctor can give him an explanation or clarify the meaning of a question and let him answer it alone. After completing the questionnaire, the subject will have no further obligations in relation to the study.The patient will complete an electronic self-questionnaire independently.
- Conditions
- Addictology
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
To prevalence of psychological, physical and sexual violence suffered or committed in a population of patients suffering from one or more addictions
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of violence among patients suffering from one or more addictions and treated in an Addictology Center.
Frequency of each type of violent act.
Measured: Between Day1 and 18 Months
Secondary outcomes (2)
Relation between addiction habits and violence
Number of positive responses
Measured: Between Day 1 and 18 Months
Percentage of positive respons in terms of frequency of violence and need for specific help.and the acceptability of specific help by patients
Number of positive responses
Measured: Between Day 1 and 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start14 Jan 2022
- Primary completion14 Jan 2022
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictologyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 4,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536245
- Sponsor's protocol ID
- Local/2021 /PP-01
- Acronym
- APREVIO
- Status last verified
- Mar 2025
- First submitted
- 7 Sep 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Prevalence of Violence Suffered or Committed by Patients Suffering From Addiction in a Care Facility
- ClinicalTrials.gov ID
- NCT05536245
- Acronym / sponsor ID
- APREVIO / Local/2021 /PP-01
- Conditions
- Addictology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 10 Sep 2022 (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.
Addictions, whether to a substance or a behavior, are often associated with violence, but their role is not well known. Despite the publication of numerous studies demonstrating the influence of addictions in acts of violence, the exploration of violence in the context of addiction remains very limited. In order to fill this gap, teams members of the Addictopôle Occitanie in collaboration with a regional team are preparing the launch of a concrete longitudinal study to analyze the incidence of violence in populations suffering from addiction, but also to evaluate the need in terms of management of this violence.
Hypotheses: To analyze the prevalence of violence in populations suffering from addiction and the need for treatment of such violence using a robust protocol based on an anonymous questionnaire to assess the violence experienced or committed by a patient, taking into account his/her environment. This study would allow us to better understand the effects of addictions on the severity and frequency of violence, but also to implement concrete and adapted solutions in order to limit it. This study could lead to the creation of a regional Observatory of Violence related to Addictions.
Translated with www.DeepL.com/Translator (free version)
Detailed description
Study visits will be conducted in the following chronological order:
- Inclusion/End Visit (IEV): D0.Eligible patients will have been identified by the investigator, and will be recruited in the Addictology Department during their usual visit.
The inclusion visit is carried out by an investigating physician who will confirm the patient's eligibility and verify his or her ability to answer the questionnaire. It will take place in the care center. It is part of the usual care.
During this visit, the investigator will:
- Perform the usual management of the patient.
- Validate the inclusion and non-inclusion criteria.
- Issue the letter of information and non-opposition ii. Self-questionnaire entry visit (Vfollow-up/end): from D0 to 18 months (part of the usual care). After inclusion, the subject has enough time (15-30 min) to fill in the questionnaire independently. If the subject asks for it, the doctor can give him an explanation or clarify the meaning of a question and let him answer it alone. After completing the questionnaire, the subject will have no further obligations in relation to the study.The patient will complete an electronic self-questionnaire independently.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients (stabilized out of crisis or under the influence of substances), men or women over 18 years of age who are able to understand the information letter and the questionnaire and to express their non-opposition. These patients must be under the care of an Addictology structure for addictive behavior, misuse of narcotics or for the consolidation of a sobriety
Key inclusion criteria (3 listed)
- Outpatient under care in an Addictology structure.
- Male or female patient over 18 years old.
- Outpatient able to express his/her non-opposition.
Key exclusion criteria (3 listed)
- Patient consulting for the first time. Patient under court protection, guardianship or curatorship. Severe psychiatric disorders that have not been stabilized: (schizophrenia, bipolar disorders, etc.).
- Severe neurological disorders that are incompatible with reliable data collection.
- Minor patients. Pregnant women, parturients. People in emergency situations, people unable to express their consent.
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 |
|---|---|---|
| QuestionnaireTo prevalence of psychological, physical and sexual violence suffered or committed in a population of patients suffering from one or more addictions | Other | – |
Primary outcome
Rate of violence among patients suffering from one or more addictions and treated in an Addictology Center.
Time frame: Between Day1 and 18 Months
Frequency of each type of violent act.
2 secondary outcomes
Relation between addiction habits and violence
Time frame: Between Day 1 and 18 Months
Percentage of positive respons in terms of frequency of violence and need for specific help.and the acceptability of specific help by patients
Time frame: Between Day 1 and 18 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addictology, run by Centre Hospitalier Universitaire de Nīmes 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of violence among patients suffering from one or more addictions and treated in an Addictology Center. (time frame: Between Day1 and 18 Months). 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 10 Mar 2025.