NCT04748822

Brief Summary

The primary purpose of this study is to investigate the factors associated with quality of life of patients with alcohol use disorder (AUD) undergoing a detoxification program (cross-sectional analysis). The secondary purpose is (1) to identify the factors associated with change in quality of life between baseline and 6-month follow-up, and (2) to identify the factors associated with alcohol relapse at 6 months (longitudinal analyses).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 19, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

3.4 years

First QC Date

January 19, 2021

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of life in patients with AUD.

    Alcohol Quality of Life Scale.

    Within the 10th and 21st day of the detoxification program (baseline assessment).

Secondary Outcomes (2)

  • Quality of life in patients with AUD 6 months after the detoxification program.

    6 months after the baseline assessment.

  • Alcohol status

    6 months after the baseline assessment.

Study Arms (1)

Quality of life of patients with AUD.

OTHER

Patients' demographic data, socioeconomic status, physical diseases, medication use, clinical features of AUD, psychiatric variables, impulsivity, autonomy, sexual functioning, sleep quality, and cognitive functioning will be measured at baseline. The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.

Other: questionnaires

Interventions

The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.

Also known as: Alcohol Quality of Life Scale (AQoLS) and Alcohol status
Quality of life of patients with AUD.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-5 AUD criteria
  • At least 18 years of age
  • Within the 10th and 21st day of a detoxification program.

You may not qualify if:

  • Communication difficulties (insufficient level of French, major hearing or visual impairment, major cognitive deficit)
  • Under guardianship
  • Under justice control
  • Cannot be reached by phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678 cedex, France

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Surveys and QuestionnairesEthanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthAlcoholsOrganic Chemicals

Study Officials

  • Benjamin ROLLAND, MD, PhD

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR
  • LOUIS FERDINAND LESPINE, MD

    CH LE VINATIER

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2021

First Posted

February 10, 2021

Study Start

March 25, 2021

Primary Completion

August 8, 2024

Study Completion

January 21, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations