CANABIC: CANnabis and Adolescents: effect of a Brief Intervention on their Consumption--study protocol for a randomized controlled trial

Catherine Laporte, Hélène Vaillant-Roussel, Bruno Pereira, Olivier Blanc, Gilles Tanguy, Paul Frappé, David Costa, Yoann Gaboreau, Mélanie Badin, Laurent Marty, Gilles Clément, Claude Dubray, Bruno Falissard, Pierre-Michel Llorca, Philippe Vorilhon, Catherine Laporte, Hélène Vaillant-Roussel, Bruno Pereira, Olivier Blanc, Gilles Tanguy, Paul Frappé, David Costa, Yoann Gaboreau, Mélanie Badin, Laurent Marty, Gilles Clément, Claude Dubray, Bruno Falissard, Pierre-Michel Llorca, Philippe Vorilhon

Abstract

Background: Cannabis is the most consumed illegal substance in France. General practitioners (GPs) are the health professionals who are most consulted by adolescents. Brief intervention (BI) is a promising care initiative for the consumption of cannabis, and could be a tool for GPs in caring for adolescents who consume cannabis. The aim of the CANABIC study is to measure the impact of a BI carried out by a GP on the consumption of cannabis by adolescents of 15 to 25 years of age.

Methods: A randomized clustered controlled trial, stratified over three areas (Auvergne, Languedoc-Roussillon, and Rhône - Alpes), comparing an intervention group, which carries out the BI in consultation, and a control group, which ensures routine medical care. The main assessment criterion is the consumption of cannabis by amount of joints per month, at 12 months. The amount necessary to highlight a significant difference between the two groups of 30% of consumption at 12 months is 250 patients (50 GPs, 5 patients per GP; risk α = 5%; power = 90%; intra-cluster correlation coefficient ρ = 0.2; Hawthorne effect = 15%; lost to follow-up rates for GPs = 10% and for patients = 20%). This plan is replicated for the three areas, and therefore a total of 750 patients are expected.The secondary criteria for judgment are the associated consumption of tobacco and alcohol, the perception of the consequences of consumption, and the driving of a vehicle following consumption.

Discussion: Research about BI for young cannabis users is underway. The aim of the CANABIC study is to validate a BI suited to adolescents who consume cannabis, which may be performed in the general practice. This would provide a tool for their treatment by a GP, which could be widely distributed during initial or further medical training.

Trial registration: CANABIC is a randomized clustered trial (NCT01433692, registered 2011 Sept 12), PHRC funded: Clinical Research Hospital Program (Governmental Fund, Health Ministry). Date first patient randomized: March 2012.

Figures

Figure 1
Figure 1
Global design of the CANABIC study.

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