F Fonseca1,2,3, J I Mestre-Pintó4,5, M P Schaub6, C Baumgartner6, M Alias-Ferri1,3, M Torrens1,3,7. 1. Addiction Research Group (GRAd), Neuroscience Research Program, Hospital del Mar Medical Research Institute (IMIM), 08003, Barcelona, Spain. 2. Department of Experimental and Health Sciences (CEXS), Universitat Pompeu Fabra, 08002, Barcelona, Spain. 3. Department of Psychiatry and Department of Pharmacology, School of Medicine, Universitat Autònoma de Barcelona (UAB), 08290, Cerdanyola del Vallès, Spain. 4. Addiction Research Group (GRAd), Neuroscience Research Program, Hospital del Mar Medical Research Institute (IMIM), 08003, Barcelona, Spain. jmestre@imim.es. 5. Department of Experimental and Health Sciences (CEXS), Universitat Pompeu Fabra, 08002, Barcelona, Spain. jmestre@imim.es. 6. Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland. 7. Institut de Neuropsiquiatria i Addiccions, Hospital del Mar, 08003, Barcelona, Spain.
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.
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.
Authors: Francisco González-Saiz; Carlos de Las Cuevas; Gregorio Barrio; Antonia Domingo-Salvany Journal: Med Clin (Barc) Date: 2008-12-06 Impact factor: 1.725