NCT06381609

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
626

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Oct 2024Apr 2028

First Submitted

Initial submission to the registry

April 2, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

June 11, 2024

Status Verified

April 1, 2024

Enrollment Period

3.5 years

First QC Date

April 2, 2024

Last Update Submit

June 10, 2024

Conditions

Keywords

Peer supportAddictionAlcohol

Outcome Measures

Primary Outcomes (1)

  • Unplanned cessation of care at 6 months

    The unplanned cessation of care at 6 months, excluding consultations with an APSS, with no further contact in the following month, is defined as having had a last planned consultation that was not fulfilled between M0 and M6

    At 6 months after inclusion

Secondary Outcomes (23)

  • Number of unfulfilled consultations

    6 months after inclusion

  • Euroqol-5D-5L questionnaire score

    At inclusion, 3 and 6 months after inclusion

  • Difference in costs (in euros)

    At 1, 2 and 3 years after the beginning of implementation on French territory

  • Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

    At inclusion, 3 and 6 months after inclusion

  • Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score

    At inclusion, 3 and 6 months after inclusion

  • +18 more secondary outcomes

Study Arms (2)

Peer support Group

EXPERIMENTAL

313 patients will be recruited over 3 years in the peer support group. Patients will be accompanied by an addiction peer support specialist, as part of an "add-on" follow-up compared with conventional follow-up (same management as in the control group).

Behavioral: Quality life questionnaire AQoLSBehavioral: Quality life questionnaire Euroqol EQ-5D-5LOther: Peer support consultations

Control Group

ACTIVE COMPARATOR

313 patients will be recruited over 3 years in the control group. Patients will receive "as usual" outpatient abstinence-maintenance follow-up, with consultations of all kinds (medical, psychological, nursing, group, etc.)

Behavioral: Quality life questionnaire AQoLSBehavioral: Quality life questionnaire Euroqol EQ-5D-5L

Interventions

Quality life questionnaire AQoLS will be completed by patients of both arms at inclusion, three and six months after inclusion

Control GroupPeer support Group

Quality life questionnaire Euroqol EQ-5D-5L will be completed by patients of both arms at inclusion, three and six months after inclusion

Control GroupPeer support Group

For patients included in the Peer support group, eight mandatory consultations with a peer support specialist will be performed between the inclusion visit and during the three following months. Patients can request additional consultations with the peer support specialist during the 6 first months of follow-up

Peer support Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CH Le Vinatier

Bron, 69500, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

GH Nord, Hospices Civils de Lyon

Lyon, 69004, France

Location

CHS St Anne

Paris, 75014, France

Location

Bichat Hospital

Paris, 75018, France

Location

MeSH Terms

Conditions

AlcoholismBehavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Benjamin ROLLAND

    Hopsices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin ROLLAND, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 24, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

June 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations