NCT01433692

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

September 12, 2011

Last Update Submit

January 11, 2013

Conditions

Keywords

AddictionsAdolescentsPrimary Health CareBrief Intervention

Outcome Measures

Primary Outcomes (1)

  • the number of joints consumed per month

    at 12 months

Secondary Outcomes (1)

  • the number of joints consumed per month

    at 3 and at 6 months

Study Arms (2)

intervention group

EXPERIMENTAL
Behavioral: Brief Intervention

control group

OTHER
Behavioral: Brief Intervention

Interventions

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 groupintervention group

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (3)

  • 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.

  • Laporte 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.

  • Laporte 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.

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Catherine LAPORTE, MD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2011

First Posted

September 14, 2011

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

July 1, 2014

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations