Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music
FALCO
3 other identifiers
interventional
600
8 countries
11
Brief Summary
FALCO is a parallel pragmatic randomized control trial addressing long-term effects of music therapy (MT) on substance use disorder (SUD). 600 participants will be recruited from multiple European countries (see Locations). They will be randomized into one of the following intervention arms: Active Music Group (AMG), Music Listening Group (MLG) or Treatment as Usual (TAU) as offered locally.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2025
CompletedFirst Posted
Study publicly available on registry
June 19, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2037
May 1, 2026
April 1, 2026
3 years
June 11, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Addiction Severity assessed by the the European Addiction Severity Index (EuropASI)
The survey covers a broad concept of addiction, including changes that typically require a long time, across seven domains (general medical condition, professional and financial situation, substance use, other drug consumption, legal problems, family and social relations, psychological condition). It has been adapted specifically for use in European contexts. The scale is clinician-based and includes 164 items, with a fine-grained Composite score of 0 (best) to 1 (worst).
Baseline, 1 year, 2 years.
Secondary Outcomes (23)
Recovery assessed by the Substance Use Recovery Evaluator (SURE)
Baseline, 1 year, 2 years.
Substance use severity assessed by Drug Disorder Identification Test (DUDIT-C)
Baseline, 3 months, 1 year, 2 years.
Substance use severity assessed by Alcohol Use Disorder Identification Test (AUDIT-C)
Baseline, 3 months, 1 year, 2 years.
Quality of life assessed by EuroQol (EQ-5D)
Baseline, 1 year, 2 years.
Depressive symptoms assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Baseline, 1 year, 2 years.
- +18 more secondary outcomes
Study Arms (3)
Active Music Group(AMG) + Treatment as Usual(TAU)
EXPERIMENTALParticipants will partake in an active music group, as well as undergo treatment as usual as offered locally.
Music Listening Group(MLG) + Treatment as Usual(TAU)
EXPERIMENTALParticipants will partake in a music listening group, as well as undergo treatment as usual as offered locally.
Treatment as Usual (TAU)
ACTIVE COMPARATORTreatment as usual, as offered locally and not facilitated by the study.
Interventions
Active music group is a music therapy intervention where participants actively make/play music in groups. The sessions will be conducted by an appropriately qualified music therapist.
Music listening group is a music therapy intervention where participants partake in music listening in groups. The sessions will be conducted by an appropriately qualified music therapist.
Treatment as usual as provided locally, which may include pharmacological and/or non-pharmacological interventions (e.g. mindfulness-based intervention, structured physical activity).
Eligibility Criteria
You may qualify if:
- patients seeking or receiving treatment at the recruitment site for an existing substance use disorder based on ICD-10 criteria
- ≥18 years old
- not currently undergoing detoxification (detoxification has been completed or is not currently planned at the time of recruitment)
- any type of substance use including polysubstance and alcohol use
You may not qualify if:
- exclusively nicotine dependence
- psychotic episode in the last 3 months
- insufficient language skills to participate in treatment without the use of a translator
- hearing impairment that considerably impairs hearing of music played at a moderate volume (not relevant if hearing is sufficiently compensated by a hearing aid)
- existing diagnosis of dementia
- is currently receiving music therapy or has received music therapy (i.e. at planned and reoccurring intervals, not counting single random occurrences) during the past year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse Stavanger HFcollaborator
- Sykehuset Innlandet HFcollaborator
- Austrian Institute for Health Technology Assessment GmbHcollaborator
- Herzog Collegecollaborator
- University of Paviacollaborator
- University of Gdańskcollaborator
- Institució Catalana de Recerca i Estudis Avançatscollaborator
- Universitat de Gironacollaborator
- Fundació Sanitària d'Igualadacollaborator
- Wojewódzki Ośrodek Terapii Uzależnień w Gdańskucollaborator
- University of Viennacollaborator
- Anton Proksch Institutcollaborator
- University of Music and Performing Arts, Viennacollaborator
- Bar-Ilan University, Israelcollaborator
- Institut d'Investigació Biomèdica de Bellvitgecollaborator
- Institut d'Investigació Biomèdica de Girona Dr. Josep Truetacollaborator
- University of Zurichcollaborator
- NORCE Norwegian Research Centre ASlead
- University of Bergencollaborator
Study Sites (11)
Anton Proksch Institut
Vienna, Austria
Herzog College
Jerusalem, Israel
University of Pavia
Pavia, Italy
University of Bergen / NORCE Research AS
Bergen, 5838, Norway
Sykehuset Innlandet
Innlandet, Norway
Stavanger Universitetssjukehus
Stavanger, Norway
Palestinian National Rehabilitation Centre
Bethlehem, Palestinian Territories
WOTU / University of Gdansk
Gdansk, Poland
Fundacio Sanitaria d'Igualada
Barcelona, Spain
IDIBGI
Girona, Spain
CAD
Zurich, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Gold, PhD
NORCE Research Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The primary outcome and all other clinician-based measures will be conducted by masked assessors. Masking success will be verified by asking the assessor at the end of the primary endpoint assessment if they inadvertently found out the participant's allocation, and if so, to state the condition they believe the participant was allocated to. Statisticians conducting analyses will also be masked, and report writing will be masked until a draft is ready.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2025
First Posted
June 19, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2037
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Upon publication of summary results; no end date
- Access Criteria
- Openly accessible
De-identified curated data will be made available permanently in publicly accessible repositories (e.g. OSF.io) using FAIR principles (e.g. using digital object identifiers \[DOIs\]; open, non-proprietary data formats; clear, consistent meta-data, using international standards for data structure where available; and licensed for re-use through CC BY). To balance the needs of trial participants for protection of their sensitive health data (in accordance with informed consent) and the needs of the scientific community for data availability, we will follow the principle "as closed as necessary, as open as possible". Results summaries will also be posted at Clinicaltrials.gov after the project end.