Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music (FALCO)

NORCE Norwegian Research Centre AS

Status: Enrolling

Conditions: Substance Use Disorder (SUD)

Treatments: Behavioral: Treatment as Usual (TAU); Behavioral: Active Music Group (AMG); Behavioral: Music Listening Group (MLG)

Study type: Interventional

Funder types: Other

Identifiers

NCT07028983

REF-1131-52304 (Other Grant/Funding Number)

107278

101155881 (Other Grant/Funding Number)

Details and patient eligibility

About

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 7 countries (Norway, Austria, Israel, Italy, Poland, Spain, Switzerland), involving 10 recruitment sites. 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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 3 patient groups

Active Music Group(AMG) + Treatment as Usual(TAU)

Experimental group

Description:

Participants will partake in an active music group, as well as undergo treatment as usual as offered locally.

Treatment:

Behavioral: Active Music Group (AMG)

Music Listening Group(MLG) + Treatment as Usual(TAU)

Experimental group

Description:

Participants will partake in a music listening group, as well as undergo treatment as usual as offered locally.

Treatment:

Behavioral: Music Listening Group (MLG)

Treatment as Usual (TAU)

Active Comparator group

Description:

Treatment as usual, as offered locally and not facilitated by the study.

Treatment:

Behavioral: Treatment as Usual (TAU)