About / Falco Research Project

About FALCO

What is the research project about?

FALCO will reduce the disease burden associated with substance use disorder (SUD) by providing reliable and generalisable evidence on innovative, effective, and affordable interventions. SUD contributes to 5.4 % of all disability-adjusted life years lost globally due to alcohol and illicit drugs, and it is often accompanied by other health problems like mental health conditions and infections.

Where traditional interventions are insufficient alone, music therapy is highly engaging and improves motivation and craving. However, the long-term effects of music therapy are still unknown.

600 people with SUD in 7 European countries will be randomly assigned to either active music groups (AMG), music listening groups (MLG), or treatment as usual (TAU). We will examine the effects to determine the best combinations of interventions. In addition, experimental studies will examine mechanisms using neuropsychological tests and brain imaging. User and stakeholder involvement throughout the entire process will ensure relevance of the research, feasibility during implementation, and efficient transfer of findings to practice.

Members of the consortium - group of people

Members of the consortium at the official launch of FALCO in Bergen, January 2025.
Photo: Andreas R. Graven, NORCE

Watch the video where Christian Gold, project leader of the FALCO project, talks about the project that will investigate and uncover the potential for music activities in drug rehabilitation.

Specific Objectives

SO 1: Evaluate What Works

Assess current and promising interventions across partner countries to understand their effectiveness.

SO 2: Run a Major Clinical Trial

Conduct a large, international RCT using shared outcome measures and health registry data.

SO 3: Harmonise and Tailor Care

Standardise protocols across Europe while adapting to specific patient needs and sub-groups.

SO 4: Collaborate with Users

Involve patients, professionals, and stakeholders in trial design and result implementation.

SO 5: Understand Human Factors

Explore psychological, neurological, and social mechanisms behind outcomes.

SO 6: Check Economic Feasibility

Evaluate cost-effectiveness and sustainability of scaling interventions nationally and at EU level.

SO 7: Share and Use Results

Disseminate findings widely through open access, stakeholder engagement, and revised guidelines.

Project information

Project start: January 2025
Participant recruitment starts from July 2025
Trial registration at clinicaltrials.gov: NCT07028983
Project page on CORDIS: ID 101155881

Work packages (WPs)

1 Preparation of trial settings and participants

2 Monitoring of recruitment progress

3-4 Treatment as usual (TAU) interventions: classification, changes

5-6 Music interventions: guidelines and training, delivery and fidelity

Objectives:

To develop intervention guidelines (two protocol guides) for two group music therapy settings (Active Music Groups and Music Listening Groups), training procedures and supervision guidelines, to ensure consistent conduct of music interventions across sites and therapists.
To develop and conduct fidelity assessment for both intervention types and to check/evaluate consistent conduct of music interventions across sites and therapists.

7-8 Long-term clinical outcomes - preparations, monitoring

Objectives:

To ensure high quality long-term clinical outcomes for the clinical trial, including primary and secondary clinical outcomes.
To prepare for reliable and efficient data collection across clinical sites using a variety of methods (paper questionnaires, online databases)
To ensure high quality long-term clinical outcomes for the clinical trial, including primary and secondary clinical outcomes
To prepare reports for publishing.

9-10 Immediate/short-term outcomes, biomarkers: preparations, analyses

Objectives:

To ensure high-quality data on immediate and short-term outcomes and potential biomarkers, including structural scans.
To prepare for reliable and efficient data collection across clinical sites using a variety of methods (paper questionnaires, online databases, biological samples, and brain scans).
To analyse data and impact of group (AMG and MLG vs. TAU) on immediate/short-term outcomes and biomarkers (incl. structural brain scans).
To prepare reports for publication.

11-12 Experimental lab studies and mechanisms: preparations, analyses

Objectives:

To harmonize fMRI scanning protocols across all participating research sites to ensure data consistency.
To include protocol information in ethics approval (WP22) for all sites to ensure compliance with ethical standards in research.
To install the necessary experiments in various fMRI laboratories and establish a robust infrastructure for data storage and analysis, utilizing the SAFE system data servers at UIB, which comply with data-safety regulations and will be accessible to all project partners.
Programming and piloting the functional task to be used in fMRI scanning: the craving fMRI task.
To enable all involved researchers to access and analyse the data on a common platform by installing relevant software and establishing data conversion and analysis scripts and pipelines.
To conduct task-based fMRI measurement sessions at 3 time points per participant.
Preprocessing, quality control, and analyses.
To investigate effects of AMG, MLG versus TAU on the functional connectivity between key brain regions associated with craving regulation.
To employ an experimental paradigm to identify neurobiological markers of craving, aiming to understand the effects of music therapy on the NCS markers.
To conduct PET-fMRI and PET with specific markers to assess dopamine regulation in response to stimuli, comparing differences between groups and hypothesizing improved regulation in the music therapy group.
To promote Open Data Archive Access for the broader research community after the publication of primary project results.

13 Preparations for clinical data collection and monitoring

14 Monitoring and statistical analysis of clinical outcomes

15 Predictive machine learning analysis of multimodal data

16-18 User/stakeholder involvement: preparation, implementation, dissemination

19-21 Communication, Dissemination, Exploitation, Sustainability (CDES)

Objectives: To plan, assess, and manage all communication, dissemination, exploitation, and sustainability activities, promoting the FALCO project, organising main outreach and workshop actions, and circulating empirically-grounded data for the discussions of efficacy, potential applications, and actual testable effects, and patient/caregiver decision support for use of music in substance use disorder.

22-23 Project management

Objectives:

To coordinate and manage the project and ensure efficient, smooth, and timely execution of all project activities.
To facilitate and ensure appropriate data management across the different data types and phases of the project.
To ensure appropriate risk management.
To implement a participatory Monitoring, Evaluation, Learning, and Improvement (MELI) framework
To ensure an accurate and timely communication flow among project partners and the European Commission to track project progress and meet objectives.
To facilitate cooperation and synergies with other initiatives to maximize the project's impact.

Now the drugs don’t work
They only make you worse

The Verve, lyrics from “The Drugs Don’t Work”