CANABIC : CANnabis and Adolescents, a Brief Intervention (BI) to Reduce Their Consumption (CANABIC)

January 11, 2013 updated by: University Hospital, Clermont-Ferrand

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 ?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: control group
Behavioral: Brief Intervention
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).
EXPERIMENTAL: intervention group
Behavioral: Brief Intervention
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the number of joints consumed per month
Time Frame: at 12 months
at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the number of joints consumed per month
Time Frame: at 3 and at 6 months
at 3 and at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Catherine LAPORTE, MD, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ANTICIPATED)

March 1, 2014

Study Completion (ANTICIPATED)

July 1, 2014

Study Registration Dates

First Submitted

September 12, 2011

First Submitted That Met QC Criteria

September 13, 2011

First Posted (ESTIMATE)

September 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Health Care

Clinical Trials on Brief Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe