Abstract
Background
Cannabis is the most-frequently used illicit drug in Europe. Over the last few years in Spain, treatment demand has increased, yet most cannabis users do not seek treatment despite the related problems. A web-based self-help tool, like CANreduce 2.0, could help these users to control their consumption.
Methods
This study protocol describes a three-arm randomized controlled trial (RCT) comparing the effectiveness of three approaches, in terms of reducing cannabis use among problematic cannabis users, the first two treatment arms including the Spanish version of CANreduce 2.0 (an adherence-focused, guidance-enhanced, web-based self-help tool) (1) with and (2) without psychological support; and the third group (3) treatment as usual (TAU). Study hypotheses will be tested concerning the primary outcome: change in the number of days of cannabis use over the previous week, comparing assessments at 6 weeks and 3 and 6 months follow-up between groups and against baseline. Secondary outcomes related to cannabis use will be tested similarly. Mental disorders will be explored as predictors of adherence and outcomes. Analyses will be performed on an intention-to-treat basis, then verified by complete case analyses.
Discussion
This study will test how effective the Spanish version of CANreduce 2.0 (CANreduce-SP) is at reducing both the frequency and quantity of cannabis use in problematic users and whether adding psychological support increases its effectiveness.
Trial registration
This trial is registered with the Clinical Trials Protocol Registration and Results System (PRS) number: NCT04517474. Registered 18 August 2020, (Archived by archive.is https://archive.is/N1Y64). The project commenced in November 2020 and recruitment is anticipated to end by November 2022.
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Details
1 Neuroscience Research Program, Hospital del Mar Medical Research Institute (IMIM), Addiction Research Group (GRAd), Barcelona, Spain (GRID:grid.20522.37) (ISNI:0000 0004 1767 9005); Universitat Pompeu Fabra, Department of Experimental and Health Sciences (CEXS), Barcelona, Spain (GRID:grid.5612.0) (ISNI:0000 0001 2172 2676)
2 Neuroscience Research Program, Hospital del Mar Medical Research Institute (IMIM), Addiction Research Group (GRAd), Barcelona, Spain (GRID:grid.20522.37) (ISNI:0000 0004 1767 9005); Universitat Pompeu Fabra, Department of Experimental and Health Sciences (CEXS), Barcelona, Spain (GRID:grid.5612.0) (ISNI:0000 0001 2172 2676); Universitat Autònoma de Barcelona (UAB), Department of Psychiatry and Department of Pharmacology, School of Medicine, Cerdanyola del Vallès, Spain (GRID:grid.7080.f) (ISNI:0000 0001 2296 0625)
3 University of Zurich, Swiss Research Institute for Public Health and Addiction, Zurich, Switzerland (GRID:grid.7400.3) (ISNI:0000 0004 1937 0650)
4 Neuroscience Research Program, Hospital del Mar Medical Research Institute (IMIM), Addiction Research Group (GRAd), Barcelona, Spain (GRID:grid.20522.37) (ISNI:0000 0004 1767 9005); Universitat Autònoma de Barcelona (UAB), Department of Psychiatry and Department of Pharmacology, School of Medicine, Cerdanyola del Vallès, Spain (GRID:grid.7080.f) (ISNI:0000 0001 2296 0625)
5 Neuroscience Research Program, Hospital del Mar Medical Research Institute (IMIM), Addiction Research Group (GRAd), Barcelona, Spain (GRID:grid.20522.37) (ISNI:0000 0004 1767 9005); Universitat Autònoma de Barcelona (UAB), Department of Psychiatry and Department of Pharmacology, School of Medicine, Cerdanyola del Vallès, Spain (GRID:grid.7080.f) (ISNI:0000 0001 2296 0625); Hospital del Mar, Institut de Neuropsiquiatria i Addiccions, Barcelona, Spain (GRID:grid.411142.3) (ISNI:0000 0004 1767 8811)