AddictionsCANABICNCT01433692
CANABIC : CANnabis and Adolescents, a Brief Intervention (BI) to Reduce Their Consumption
A study testing Brief Intervention in people with Addictions and Adolescents, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Background: Cannabis is the most prevalent illegal drug used in France, and consequences arising from the step of 'casual consumers'(1-10 joints/month). Side effects of cannabis are now well documented: Trauma (driving after consuming cannabis), respiratory, cardiovascular diseases and psychiatric and social problems. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Addictions, Adolescents, Primary Health Care
- What is being tested?
- Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Jul 2014
- Phase
- Interventional
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents 15 to 25 years Repetead users : 1 to 10 per month; regular users : 11 to 29 per month; daily users : 1 and more per day.
- The patient must have given his informed consent and signed the form of no objection
Who cannot join
- Adolescents with psychiatric illness considered by the attending physician in acute decompensated
- Intellectual Disability
- Hard of hearing
- No French language skills
- Patient already under treatment for the withdrawal of an addicition to cannabis or other substance
- Adolescents who participated in the preliminary qualitative study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Official title: Does a BI Conducted by General Practitioners Reduce Consumption of Canabis in 15 to 25 Years Old ?
Background: Cannabis is the most prevalent illegal drug used in France, and consequences arising from the step of 'casual consumers'(1-10 joints/month). Side effects of cannabis are now well documented: Trauma (driving after consuming cannabis), respiratory, cardiovascular diseases and psychiatric and social problems. The general practitioner (GP) is the health professional most viewed by adolescents. Brief interventions (BI) for adult alcohol use have been shown to be efficient. Some BI have been designed to inspect adolescents and consumption of cannabis have been piloted, showing their feasibility, but no test has validated them.
Aim : Does a BI conducted by general practitioners reduce consumption of canabis in 15 to 19 years old ?
Read more
Method:
Two preliminary qualitative studies (with adolescents and GP), were used to analyze the difficulties of communication around cannabis use. The Scientific Committee has analyzed the results and developed a workshop around BI, adapted to adolescents cannabis users.
CANABIC is a quantitative study to validate use of BI with cannabis users: a randomized controlled trial, clustered study, comparing an intervention group (IG) and a control group (CG). The intervention is the achievement of the IB during a specific consultation. The outcome is the consumption of cannabic (Number of joints / month).
The study will be carried out in 3 french regions : Auvergne, Rhône-Alpes and Languedoc-Roussillon. 150 GPs wil be recruited and randomized in intervention group or control group (ratio 1 :1).
Each GP will inlcude 5 adolescents (i.e. a total of 750 adolescents) - . The number of adolescents needed has been calculate with hypothesis of a significant difference of 30% in consumption of cannabis between adolescents who beneficied of BI (IG) and those who do not experienced BI ( CG) A pilot study has been conducted. Cannabis use by adolescents has decreased. Their perception of cannabis has changed: they are aware of the harmful effects of their consumption. This pilot study has improve many points of the protocol.
Results:
A decrease of 30% of consumption is expected (joints per month). Perception of cannabis by adolescents will be reviewed.
Conclusions:
To validate an IB adaptated to consultation with adolscents cannabis consumer in order to provide a tool for GP in their daily practice.
Read the detailed description
General organisation of the study
- Recruitment of the GP: 3 months (from December 2011 to March 2012)
- Training of the intervention group GP during a one-day training, in March 2012, on 3 thematic: relationship between GP and adolescent, cannabis and BI; by an expert team
- Inclusion period : 10 months (from April 2012 to January 2013). The included patients will be followed for 12 months. There are 3 follow up consultations at 3, 6 and 12 months.
- First consultation used to the inclusion:
Information to the patient and collection of the patient non opposition (without informing the intervention objectives in the control group).
Evaluation of cannabis consumption, but also tobacco and alcohol consumption. Collection of the perception of cannabis by adolescents, and its impact on health.
Inclusion criteriae : repetead users : 1 to 10 per month; regular users : 11 to 29 per month; daily users : 1 and more per day.
In the IG : achievment of the BI with the adolescent. In each group, making appointment with the patient at 3 months
- Follow up consultations : At 3, 6 and 12 months. Evaluation of cannabis consumption, but also tobacco and alcohol consumption. Collection of the perception of cannabis by adolescents, and its impact on health.
- Conditions
- Addictions, Adolescents, Primary Health Care, Brief Intervention
- Being tested
- Brief Intervention
- Keywords
- Addictions, Adolescents, Primary Health Care, Brief Intervention
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
CANABIC is a quantitative study to validate use of BI with cannabis users: a randomized controlled trial, clustered study, comparing an intervention group (IG) and a control group (CG). The intervention is the achievement of the IB during a specific consultation. The outcome is the consumption of cannabic (Number of joints / month).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Behavioral: Brief Intervention |
| control group | Other | Not described Receives: Behavioral: Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of joints consumed per month
Measured: at 12 months
Secondary outcomes (1)
the number of joints consumed per month
Measured: at 3 and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AddictionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine LAPORTE, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433692
- Sponsor's protocol ID
- CHU-0103
- Acronym
- CANABIC
- Status last verified
- Jan 2013
- First submitted
- 12 Sep 2011
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Laporte C, Lambert C, Pereira B, Blanc O, Authier N, Balayssac D, Brousse G, Vorilhon P. Cannabis users: Screen systematically, treat individually. A descriptive study of participants in a randomized trial in primary care. PLoS One. 2019 Dec 2;14(12):e0224867. doi: 10.1371/journal.pone.0224867. eCollection 2019.
PubMed 31790425Laporte C, Vaillant-Roussel H, Pereira B, Blanc O, Eschalier B, Kinouani S, Brousse G, Llorca PM, Vorilhon P. Cannabis and Young Users-A Brief Intervention to Reduce Their Consumption (CANABIC): A Cluster Randomized Controlled Trial in Primary Care. Ann Fam Med. 2017 Mar;15(2):131-139. doi: 10.1370/afm.2003.
PubMed 28289112Laporte C, Vaillant-Roussel H, Pereira B, Blanc O, Tanguy G, Frappe P, Costa D, Gaboreau Y, Badin M, Marty L, Clement G, Dubray C, Falissard B, Llorca PM, Vorilhon P. CANABIC: CANnabis and Adolescents: effect of a Brief Intervention on their Consumption--study protocol for a randomized controlled trial. Trials. 2014 Jan 30;15:40. doi: 10.1186/1745-6215-15-40.
PubMed 24479702
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a BI Conducted by General Practitioners Reduce Consumption of Canabis in 15 to 25 Years Old ?
- ClinicalTrials.gov ID
- NCT01433692
- Acronym / sponsor ID
- CANABIC / CHU-0103
- Conditions
- Addictions, Adolescents, Primary Health Care, Brief Intervention
- Keywords
- Addictions, Adolescents, Primary Health Care, Brief Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 14 Sep 2011 (estimated)
- 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: Cannabis is the most prevalent illegal drug used in France, and consequences arising from the step of 'casual consumers'(1-10 joints/month). Side effects of cannabis are now well documented: Trauma (driving after consuming cannabis), respiratory, cardiovascular diseases and psychiatric and social problems. The general practitioner (GP) is the health professional most viewed by adolescents. Brief interventions (BI) for adult alcohol use have been shown to be efficient. Some BI have been designed to inspect adolescents and consumption of cannabis have been piloted, showing their feasibility, but no test has validated them.
Aim : Does a BI conducted by general practitioners reduce consumption of canabis in 15 to 19 years old ?
Method:
Two preliminary qualitative studies (with adolescents and GP), were used to analyze the difficulties of communication around cannabis use. The Scientific Committee has analyzed the results and developed a workshop around BI, adapted to adolescents cannabis users.
CANABIC is a quantitative study to validate use of BI with cannabis users: a randomized controlled trial, clustered study, comparing an intervention group (IG) and a control group (CG). The intervention is the achievement of the IB during a specific consultation. The outcome is the consumption of cannabic (Number of joints / month).
The study will be carried out in 3 french regions : Auvergne, Rhône-Alpes and Languedoc-Roussillon. 150 GPs wil be recruited and randomized in intervention group or control group (ratio 1 :1).
Each GP will inlcude 5 adolescents (i.e. a total of 750 adolescents) - . The number of adolescents needed has been calculate with hypothesis of a significant difference of 30% in consumption of cannabis between adolescents who beneficied of BI (IG) and those who do not experienced BI ( CG) A pilot study has been conducted. Cannabis use by adolescents has decreased. Their perception of cannabis has changed: they are aware of the harmful effects of their consumption. This pilot study has improve many points of the protocol.
Results:
A decrease of 30% of consumption is expected (joints per month). Perception of cannabis by adolescents will be reviewed.
Conclusions:
To validate an IB adaptated to consultation with adolscents cannabis consumer in order to provide a tool for GP in their daily practice.
Detailed description
General organisation of the study
- Recruitment of the GP: 3 months (from December 2011 to March 2012)
- Training of the intervention group GP during a one-day training, in March 2012, on 3 thematic: relationship between GP and adolescent, cannabis and BI; by an expert team
- Inclusion period : 10 months (from April 2012 to January 2013). The included patients will be followed for 12 months. There are 3 follow up consultations at 3, 6 and 12 months.
- First consultation used to the inclusion:
Information to the patient and collection of the patient non opposition (without informing the intervention objectives in the control group).
Evaluation of cannabis consumption, but also tobacco and alcohol consumption. Collection of the perception of cannabis by adolescents, and its impact on health.
Inclusion criteriae : repetead users : 1 to 10 per month; regular users : 11 to 29 per month; daily users : 1 and more per day.
In the IG : achievment of the BI with the adolescent. In each group, making appointment with the patient at 3 months
- Follow up consultations : At 3, 6 and 12 months. Evaluation of cannabis consumption, but also tobacco and alcohol consumption. Collection of the perception of cannabis by adolescents, and its impact on health.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Brief Intervention |
| control group | Other | Behavioral: Brief Intervention |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents 15 to 25 years Repetead users : 1 to 10 per month; regular users : 11 to 29 per month; daily users : 1 and more per day.
- The patient must have given his informed consent and signed the form of no objection
Key exclusion criteria (6 listed)
- Adolescents with psychiatric illness considered by the attending physician in acute decompensated
- Intellectual Disability
- Hard of hearing
- No French language skills
- Patient already under treatment for the withdrawal of an addicition to cannabis or other substance
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 |
|---|---|---|
| Brief InterventionCANABIC is a quantitative study to validate use of BI with cannabis users: a randomized controlled trial, clustered study, comparing an intervention group (IG) and a control group (CG). The intervention is the achievement of the IB during a specific consultation. The outcome is the consumption of cannabic (Number of joints / month). | Behavioural | control group, intervention group |
Primary outcome
the number of joints consumed per month
Time frame: at 12 months
1 secondary outcome
the number of joints consumed per month
Time frame: at 3 and at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
- Derived from this study: PubMed 31790425Laporte C, Lambert C, Pereira B, Blanc O, Authier N, Balayssac D, Brousse G, Vorilhon P. Cannabis users: Screen systematically, treat individually. A descriptive study of participants in a randomized trial in primary care. PLoS One. 2019 Dec 2;14(12):e0224867. doi: 10.1371/journal.pone.0224867. eCollection 2019.
- Derived from this study: PubMed 28289112Laporte C, Vaillant-Roussel H, Pereira B, Blanc O, Eschalier B, Kinouani S, Brousse G, Llorca PM, Vorilhon P. Cannabis and Young Users-A Brief Intervention to Reduce Their Consumption (CANABIC): A Cluster Randomized Controlled Trial in Primary Care. Ann Fam Med. 2017 Mar;15(2):131-139. doi: 10.1370/afm.2003.
- Derived from this study: PubMed 24479702Laporte C, Vaillant-Roussel H, Pereira B, Blanc O, Tanguy G, Frappe P, Costa D, Gaboreau Y, Badin M, Marty L, Clement G, Dubray C, Falissard B, Llorca PM, Vorilhon P. CANABIC: CANnabis and Adolescents: effect of a Brief Intervention on their Consumption--study protocol for a randomized controlled trial. Trials. 2014 Jan 30;15:40. doi: 10.1186/1745-6215-15-40.
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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.
Catherine LAPORTE, MD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention in people with Addictions and Adolescents, run by University Hospital, Clermont-Ferrand 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 14 Jan 2013. 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 Patrick LACARIN (04 73 75 1195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of joints consumed per month (time frame: at 12 months). 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 NCT01433692, which also lists 3 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 14 Jan 2013.