Fighting Addictions, improving Lives through COmprehensive drug rehabilitation with music (FALCO): Protocol for an international randomised controlled trial

Background Substance use disorders (SUD) are associated with a high global burden of disease, with 5.4adjusted life years lost due to alcohol and illicit drugs. Highly prevalent multimorbidity includes polysubstance use, mental health conditions, and other non-communicable and infectious diseases. Where traditional treatments are insufficient alone, music therapy (MT) is highly engaging and improves motivation and reduces craving; however, its long-term effects are unknown. The present study aims to examine long-term effects of active music groups (AMG) and music listening groups (MLG) versus treatment as usual (TAU) on addiction severity, recovery, and other outcomes in people with SUD Immediate and short-term effects, as well as mechanisms of these interventions, will also be examined.Methods In individuals with SUD across a wide range of age, gender, socioeconomic, and cultural backgrounds, a parallel 3-arm assessor-blinded pragmatic multinational randomised controlled trial (RCT) with embedded exploratory trials and mechanistic studies will determine long-term effects of AMG and MLG versus TAU on addiction severity (primary endpoint: 1 year), recovery, and other outcomes. Embedded trials will examine immediate effects of AMG or MLG combined with individual components of TAU combined to determine the best combinations of interventions. Experimental studies will examine mechanisms using cognitive testing and brain imaging. With 600 participants in 7 countries randomised, the trial will have 80 health technology assessment (HTA) bodies, and interventionists have been involved from conception and will ensure feasibility and applicability of the intervention across Europe.Discussion This document describes the FALCO RCT, the main part of the FALCO project, which aims to reduce disease burden through innovative, effective, and affordable treatment, and will strengthen research and innovation expertise. Recommendations from FALCO will inform intervention delivery across Europe and beyond, leading to increased safety, effectiveness, and cost-effectiveness, and improved quality of life for individuals with SUD. Stakeholders will be involved in communicating findings across all European countries and regions and ensuring that findings are effectively implemented.Trial registration ClinicalTrials.gov, NCT07028983, registered 11th of June 2025. https://clinicaltrials.gov/study/NCT07028983Competing Interest StatementThe authors have declared no competing interest.Clinical TrialNCT07028983Funding StatementThis project is funded by Horizon Europe, HORIZON-HLTH-2024-DISEASE-03-08-two-stage - Comparative effectiveness research for healthcare interventions in areas of high public health need (ID 101155881), and Swiss State Secretariat for Education, Research and Innovation (REF-1131-52304).Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:The Regional Committees for Medical and Health Research Ethics, REK Vest, Norway, gave ethical approval for this work (reference number 846924).I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.YesAt the end of the project, anonymized curated data will be made available permanently in publicly accessible repositories (e.g. Open Science Foundation, OSF.io for clinical data and OpenNeuro for brain imaging data).