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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01433692
First received: September 12, 2011
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Addictions
Adolescents
Primary Health Care
Brief Intervention
Behavioral: Brief Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Does a BI Conducted by General Practitioners Reduce Consumption of Canabis in 15 to 25 Years Old ?

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • the number of joints consumed per month [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the number of joints consumed per month [ Time Frame: at 3 and at 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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).

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.

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433692

Contacts
Contact: Patrick LACARIN 04 73 75 1195 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Catherine LAPORTE, MD University Hospital, Clermont-Ferrand
  More Information

No publications provided by University Hospital, Clermont-Ferrand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01433692     History of Changes
Other Study ID Numbers: CHU-0103
Study First Received: September 12, 2011
Last Updated: January 11, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Addictions
Adolescents
Primary Health Care
Brief Intervention

ClinicalTrials.gov processed this record on October 01, 2014