Clinical trial Recruiting at 7 sites Interventional Ages 18 and up

Comprehensive drug rehabilitation using music therapy

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

Run by NORCE Norwegian Research Centre AS · NCT07028983 · Data updated 2026-11-12

This trial will test whether adding weekly group active music-making or guided music listening to usual local care helps adults with substance use disorders reduce substance use and improve recovery.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment600 (estimated)
SponsorNORCE Norwegian Research Centre AS
Academic / other
Locations11 sites (Vienna and 10 other locations)
StatusRecruiting
StartedJuly 1, 2025
Main results expectedJune 30, 2028
Study endsJune 30, 2037
Registry record updatedOctober 23, 2026
Trial IDNCT07028983 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) who are seeking or receiving treatment for an ICD-10 diagnosed substance use disorder (including alcohol and polysubstance use), who are not currently undergoing detoxification and can attend weekly group sessions, are ideal candidates.

Probably not a fit

People with nicotine-only dependence, a psychotic episode within the last 3 months, dementia, substantial uncorrected hearing impairment, insufficient language skills for treatment without a translator, or those already receiving ongoing music therapy are excluded and unlikely to benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

FALCO is a pragmatic, parallel three-arm randomized trial enrolling about 600 adults with substance use disorders across multiple international sites. Participants are randomized to Active Music Group (AMG), Music Listening Group (MLG), or Treatment as Usual (TAU), with AMG and MLG delivered weekly in groups by qualified music therapists for sessions up to 90 minutes. The trial is assessor- and statistician-blinded and compares the long-term effects of the two music therapy approaches versus local usual care on addiction-related outcomes. Participants continue any locally offered treatments while taking part.

Why it matters

Potential benefit: If successful, adding structured music therapy could reduce substance use, support recovery, and improve quality of life as a non-pharmacological treatment option.

How similar studies have gone: Some smaller trials and guideline recommendations support music therapy as a helpful psychosocial approach in SUD, but large, blinded multinational randomized trials are still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

  • Anton Proksch Institut
    Vienna, Austria
    Recruiting
  • Herzog College
    Jerusalem, Israel
    Recruiting
  • University of Pavia
    Pavia, Italy
    Recruiting
  • University of Bergen / NORCE Research AS
    Bergen, Norway
    Recruiting
  • WOTU / University of Gdansk
    Gdansk, Poland
    Recruiting
  • Fundacio Sanitaria d'Igualada
    Barcelona, Spain
    Recruiting
Show 5 more locations
  • Cad
    Zurich, Switzerland
    Recruiting
  • Sykehuset Innlandet
    Innlandet, Norway
    Suspended
  • Stavanger Universitetssjukehus
    Stavanger, Norway
    Suspended
  • Palestinian National Rehabilitation Centre
    Bethlehem, Palestinian Territories
    Not yet recruiting
  • Idibgi
    Girona, Spain
    Withdrawn

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.