Clinical trial NCT06381609: Peer Support in Alcohol Dependence
Official title: Contribution of Addiction Peer Support on Adherence to Care and Clinical Outcomes in Alcohol Dependence: a Prospective Controlled Trial With Medico-economic Component
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Peer support
Addiction
Alcohol
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 626
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment.

However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome.

Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation.

Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care.

This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18
* Socially insured
* Meeting DSM-5 criteria for alcohol use disorder (AUD)
* Abstinent from alcohol and involved in supervised alcohol withdrawal for at least 5 days and no more than 21 days (outpatient or inpatient)
* Starting a post-detoxification outpatient program

Exclusion Criteria:

* Other severe substance use disorder, i.e. DSM-5 criteria ≥ 6 (excluding tobacco)
* Patient under protective measure (safeguard measure, guardianship) or deprived of liberty or in ordered care and hospitalization measures without consent.
* Inability to communicate and express oneself orally in French, compromising the possibility of exchanges between the Peer support and the patient.
* Psychiatric or cognitive comorbidities making inclusion impossible, at the investigator's discretion.
* Individual accompaniment by a Peer support in the 15 days prior to inclusion.

Primary outcomes:
measure: Unplanned cessation of care at 6 months
timeFrame: At 6 months after inclusion
Secondary outcomes:
measure: Number of unfulfilled consultations
timeFrame: 6 months after inclusion
measure: Euroqol-5D-5L questionnaire score
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: Difference in costs (in euros)
timeFrame: At 1, 2 and 3 years after the beginning of implementation on French territory
measure: Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: average number of standard drinks declared per week
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: Alcohol Quality of Life Scale (AQoLS) score
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: State-Trait Anxiety Inventory (STAI-Y) score
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) score
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: Cannabis Use Disorders Identification Test - Revised (CUDIT-R) score
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: type of opioid use
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: frequency of opioid use
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: type of psychostimulant use
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: frequency of psychostimulant use
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: Fagerström test score
timeFrame: At inclusion, 3 and 6 months after inclusion
measure: Health Care Satisfaction Questionnaire (HCSQ) score
timeFrame: At 6 months after inclusion
measure: Number of hospitalisations
timeFrame: At 6 months after inclusion
measure: Service organization description
timeFrame: Before setting up of the study
measure: Description of type of support and missions performed by Peer Support
timeFrame: After last visit of last patient (around 3,5 years after first inclusion)
measure: Acceptability of Intervention Measure (AIM) score
timeFrame: After last visit of last patient (around 3,5 years after first inclusion)
measure: AIM score
timeFrame: At 6 months after inclusion
measure: Adoption of intervention
timeFrame: After last visit of last patient (around 3,5 years after first inclusion)
measure: Intervention fidelity
timeFrame: After last visit of last patient (around 3,5 years after first inclusion)
Other outcomes:
Locations:
city: Bron
country: France
facility: CH Le Vinatier
city: Clichy
country: France
facility: Hôpital Beaujon
city: Lyon
country: France
facility: GH Nord, Hospices Civils de Lyon
city: Paris
country: France
facility: CHS St Anne
city: Paris
country: France
facility: Bichat Hospital
Study officials:
affiliation: Hopsices Civils de Lyon
name: Benjamin ROLLAND
role: PRINCIPAL_INVESTIGATOR
References: