NCT07028983

Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music

Fighting Addictions, Improving Lives Through COmprehensive Drug Rehabilitation With Music (FALCO): International Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: NORCE Norwegian Research Centre AS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Substance use disorder (SUD) is associated with a high global burden of disease: 4.2% of all disability-adjusted life years lost (DALYs, a combined measure of years of life lost and years lived with disability) are due to alcohol and 1.3% due to illicit drugs. Remarkably, approved pharmacological treatment options are not available for most SUDs, and non-pharmacological approaches are still the backbone of SUD treatment. Music therapy (MT) is a non-pharmacological intervention recommended i some SUD guidelines. In MT, defined as the clinical and evidence-based use of music interventions to accomplish individualized goals within a therapeutic relationship by a credentialed professional, a music therapist uses music and musical activities to support individuals or groups in reaching specific therapeutic goals. This includes activities such as music listening and active music making, which are tailored to participants' cultural context and individual needs. The FALCO-trial is a parallel 3-arm assessor- and statistician-blinded pragmatic multinational randomized clinical trial. The interventions of interest in the trial (AMG, MLG) are non-pharmacological psychosocial interventions. Both AMG and MLG will be conducted by appropriately qualified music therapists, in groups, with weekly sessions lasting up to 90 minutes. Participants will continue to receive TAU as offered locally. The primary objective of the study is to determine effects of AMG and MLG versus TAU on addiction severity in people with SUD at one year after randomization.

Conditions

• Substance Use Disorder (SUD)

Interventions

Type	Name	Description
BEHAVIORAL	Active Music Group (AMG)	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.
BEHAVIORAL	Music Listening Group (MLG)	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.
BEHAVIORAL	Treatment as Usual (TAU)	Treatment as usual as provided locally, which may include pharmacological and/or non-pharmacological interventions (e.g. mindfulness-based intervention, structured physical activity).

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-06-30
• Completion: 2037-06-30
• First posted: 2025-06-19
• Last updated: 2026-02-17

Locations

11 sites across 8 countries: Austria, Israel, Italy, Norway, Palestinian Territories, Poland, Spain, Switzerland