Comprehensive drug rehabilitation using music therapy
Fighting Addictions, Improving Lives Through COmprehensive Drug Rehabilitation With Music (FALCO): International Randomised Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NORCE Norwegian Research Centre AS Academic / other |
| Locations | 11 sites (Vienna and 10 other locations) |
| Trial ID | NCT07028983 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Vienna and 10 other locations
- Anton Proksch Institut — Vienna, Austria (Not_yet_recruiting)
- Herzog College — Jerusalem, Israel (Recruiting)
- University of Pavia — Pavia, Italy (Recruiting)
- University of Bergen / NORCE Research AS — Bergen, Norway (Not_yet_recruiting)
- Sykehuset Innlandet — Innlandet, Norway (Suspended)
- Stavanger Universitetssjukehus — Stavanger, Norway (Suspended)
- Palestinian National Rehabilitation Centre — Bethlehem, Palestinian Territories (Not_yet_recruiting)
- WOTU / University of Gdansk — Gdansk, Poland (Recruiting)
- Fundacio Sanitaria d'Igualada — Barcelona, Spain (Recruiting)
- Idibgi — Girona, Spain (Withdrawn)
- Cad — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christian Gold, PhD — NORCE Research Centre
- Study coordinator: Christian Gold, PhD
- Email: chgo@norceresearch.no
- Phone: +47 975 01 757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.