Cannabis UseNCT03659942
Study of the Cannabis Use of Minors Imprisoned in the PACA Region
An observational study of Cannabis Use, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
To date, there is little data on the consumption of young adults in detention. The main objective of this project is to document the prevalence of problematic cannabis use before incarceration among juveniles detained in the various detention centers in the PACA Secondary objectives are to document: the prevalence of… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cannabis Use
- What is being tested?
- CAST questionnaire
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2019to Jun 2020
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients new arriving in prison
Who may be able to join
- Newcomer subject in detention,
- Subject having been informed about the study and not expressing opposition to participating in the study.
- Legal officer who was informed about the study and did not express any opposition to participate in the study.
- Subject including French and able to fill self-questionnaires, and not presenting attacks of the severe cognitive functions
Who cannot join
- Subject already incarcerated less than 6 months before its inclusion,
- subject with severe hearing loss,
- Subject not having agreed to participate in the study,
- Holder of parental authority who has not given his consent,
- Subject not including French.
Trial locations and contacts
1 site in 1 country.
OLIVIER BAGNIS, MD contact
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
OLIVIER BAGNIS, MD, Olivier.BAGNIS@ap-hm.fr
About this study
Official title: Study of the Cannabis Use of Minors Imprisoned in the PACA Region (France)
To date, there is little data on the consumption of young adults in detention.
The main objective of this project is to document the prevalence of problematic cannabis use before incarceration among juveniles detained in the various detention centers in the PACA
Read more
Secondary objectives are to document:
- the prevalence of cannabis use over the course of life, last year and last month;
- the prevalence of harm and risky behavior associated with the use of a psychoactive substance
- associated addictions and first and foremost tobacco
- the determinants (socio-demographic, socio-economic, environmental, etc.) of problem use and cannabis use.
This is a multicenter cross-sectional study aimed at establishing an exhaustive picture of the defined population region over a 12-month period.
The holder of the parental authority exercise and the individual agreeing to participate in the study must:
- sign an informed consent a no objection card
- complete a car book and hetero-questionnaires. The time of handover is evaluated at 30 minutes.
The CAST questionnaire will be used to answer the main purpose of the study and to identify consumers with problematic cannabis use.
CAST scores will be calculated. Abnormal CAST proportions will be presented along with their 95% confidence intervals. The links between the score and the various variables identified as determinants will be tested using uni and multivariate analyzes.
The assessment of the health status and needs of this extremely vulnerable population is a prerequisite for defining specific regional objectives and for establishing a coherent and coordinated effective health intervention within the community. prisoner in France.
Read the detailed description
To date, there is little data on the consumption of young adults in detention when they are the first consumers in the general population in France and they represent a particularly vulnerable population within the prison population.
objectives The main objective of this project is to document the prevalence of problematic cannabis use before incarceration among juveniles detained in the various detention centers in the P.A.C.A.
Secondary objectives are to document:
- the prevalence of cannabis use over the course of life, last year and last month;
- the prevalence of harm and risky behavior associated with the use of a psychoactive substance
- associated addictions and first and foremost tobacco
- the determinants (socio-demographic, socio-economic, environmental, etc.) of problem use and cannabis use.
Method This is a multicenter cross-sectional study aimed at establishing an exhaustive picture of the defined population (juvenile detainees in the P.A.C.A.) region over a 12-month period.
The holder of the parental authority exercise and the individual agreeing to participate in the study must:
- sign an informed consent a no objection card
- complete a car book and hetero-questionnaires. The time of handover is evaluated at 30 minutes.
The CAST questionnaire will be used to answer the main purpose of the study and to identify consumers with problematic cannabis use.
CAST scores will be calculated. Abnormal CAST proportions will be presented along with their 95% confidence intervals. The links between the score and the various variables identified as determinants (socio-demographic, socio-economic, environmental, other addictions, etc.) will be tested using uni and multivariate analyzes.
Expected results The assessment of the health status and needs of this extremely vulnerable population is a prerequisite for defining specific regional objectives and for establishing a coherent and coordinated effective health intervention within the community. prisoner in France.
- Conditions
- Cannabis Use
- Being tested
- CAST questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAST questionnaireOther
the CAST questionnaire will be used to answer the main objective of the study and to identify consumers with problematic cannabis use. This is a validated self-questionnaire in France (Legleye et al., 2011), specific to the adolescent population, which is interpreted according to the score obtained (Bastiani et al., 2013, Legleye et al. 2007, Legleye et al., 2011). It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | New child arriving in detention CAST questionnaire will be performed Receives: Other: CAST questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAST questionnaire score
the CAST questionnaire will be used to answer the main objective of the study and to identify consumers with problematic cannabis use. This is a validated self-questionnaire in France (Legleye et al., 2011), specific to the adolescent population, which is interpreted according to the score obtained. It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659942
- Sponsor's protocol ID
- 2017-25
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 6 Sep 2018
- 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 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Cannabis Use of Minors Imprisoned in the PACA Region (France)
- ClinicalTrials.gov ID
- NCT03659942
- Acronym / sponsor ID
- 2017-25
- Conditions
- Cannabis Use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 6 Sep 2018 (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.
To date, there is little data on the consumption of young adults in detention.
The main objective of this project is to document the prevalence of problematic cannabis use before incarceration among juveniles detained in the various detention centers in the PACA
Secondary objectives are to document:
- the prevalence of cannabis use over the course of life, last year and last month;
- the prevalence of harm and risky behavior associated with the use of a psychoactive substance
- associated addictions and first and foremost tobacco
- the determinants (socio-demographic, socio-economic, environmental, etc.) of problem use and cannabis use.
This is a multicenter cross-sectional study aimed at establishing an exhaustive picture of the defined population region over a 12-month period.
The holder of the parental authority exercise and the individual agreeing to participate in the study must:
- sign an informed consent a no objection card
- complete a car book and hetero-questionnaires. The time of handover is evaluated at 30 minutes.
The CAST questionnaire will be used to answer the main purpose of the study and to identify consumers with problematic cannabis use.
CAST scores will be calculated. Abnormal CAST proportions will be presented along with their 95% confidence intervals. The links between the score and the various variables identified as determinants will be tested using uni and multivariate analyzes.
The assessment of the health status and needs of this extremely vulnerable population is a prerequisite for defining specific regional objectives and for establishing a coherent and coordinated effective health intervention within the community. prisoner in France.
Detailed description
To date, there is little data on the consumption of young adults in detention when they are the first consumers in the general population in France and they represent a particularly vulnerable population within the prison population.
objectives The main objective of this project is to document the prevalence of problematic cannabis use before incarceration among juveniles detained in the various detention centers in the P.A.C.A.
Secondary objectives are to document:
- the prevalence of cannabis use over the course of life, last year and last month;
- the prevalence of harm and risky behavior associated with the use of a psychoactive substance
- associated addictions and first and foremost tobacco
- the determinants (socio-demographic, socio-economic, environmental, etc.) of problem use and cannabis use.
Method This is a multicenter cross-sectional study aimed at establishing an exhaustive picture of the defined population (juvenile detainees in the P.A.C.A.) region over a 12-month period.
The holder of the parental authority exercise and the individual agreeing to participate in the study must:
- sign an informed consent a no objection card
- complete a car book and hetero-questionnaires. The time of handover is evaluated at 30 minutes.
The CAST questionnaire will be used to answer the main purpose of the study and to identify consumers with problematic cannabis use.
CAST scores will be calculated. Abnormal CAST proportions will be presented along with their 95% confidence intervals. The links between the score and the various variables identified as determinants (socio-demographic, socio-economic, environmental, other addictions, etc.) will be tested using uni and multivariate analyzes.
Expected results The assessment of the health status and needs of this extremely vulnerable population is a prerequisite for defining specific regional objectives and for establishing a coherent and coordinated effective health intervention within the community. prisoner in France.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: CAST questionnaireNew child arriving in detention CAST questionnaire will be performed |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients new arriving in prison
Key inclusion criteria (4 listed)
- Newcomer subject in detention,
- Subject having been informed about the study and not expressing opposition to participating in the study.
- Legal officer who was informed about the study and did not express any opposition to participate in the study.
- Subject including French and able to fill self-questionnaires, and not presenting attacks of the severe cognitive functions
Key exclusion criteria (5 listed)
- Subject already incarcerated less than 6 months before its inclusion,
- subject with severe hearing loss,
- Subject not having agreed to participate in the study,
- Holder of parental authority who has not given his consent,
- Subject not including French.
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 |
|---|---|---|
| CAST questionnairethe CAST questionnaire will be used to answer the main objective of the study and to identify consumers with problematic cannabis use. This is a validated self-questionnaire in France (Legleye et al., 2011), specific to the adolescent population, which is interpreted according to the score obtained (Bastiani et al., 2013, Legleye et al. 2007, Legleye et al., 2011). It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7 | Other | Experimental group |
Primary outcome
CAST questionnaire score
Time frame: 30 minutes
the CAST questionnaire will be used to answer the main objective of the study and to identify consumers with problematic cannabis use. This is a validated self-questionnaire in France (Legleye et al., 2011), specific to the adolescent population, which is interpreted according to the score obtained. It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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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.
OLIVIER BAGNIS, MD contact
EMILIE GARRIDO PRADALIE study director
APHM
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 Cannabis Use, run by Assistance Publique Hopitaux De Marseille 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 4 inclusion and 5 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 6 Sep 2018. 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?
Contact OLIVIER BAGNIS, MD (Olivier.BAGNIS@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAST questionnaire score (time frame: 30 minutes). 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 6 Sep 2018.