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OpenTrials
Completed

NCT Number: NCT04748822

Quality of Life in Patients With Alcohol Use Disorder

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Le Vinatier

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

About this study

The standard DSM-5-based clinical assessment of AUD includes the number of AUD criteria (between 2 and 11) as well as various parameters related to the patterns of alcohol use (e.g., frequency of use, frequency of heavy use). In the contemporary clinical practice, more "functional" assessment tools are emerging such as quality of life, autonomy, cognitive functioning, but also other non-specific lifestyle habits, such as sleep quality and sexual functioning. These indicators are important because they define the broad impact of AUD on individual's life, and they are part of the overall rehabilitation, beyond the mere question of the relationship to alcohol. However, the determinants of quality of life of patients with AUD patients undergoing a detoxification program, and the factors associated with change in quality of life are not well identified.

This prospective cohort study will recruit 200 patients undergoing a detoxification program (home-based or in addiction services). 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

questionnaires

Other

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 names: Alcohol Quality of Life Scale (AQoLS) and Alcohol status

Primary outcomes

  1. Quality of life in patients with AUD.

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

    Alcohol Quality of Life Scale.

Secondary outcomes

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

    Time frame: 6 months after the baseline assessment.

    Alcohol Quality of Life Scale.

  2. Alcohol status

    Time frame: 6 months after the baseline assessment.

    Alcohol (relapse/abstinence)

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

Factors Associated With Quality of Life in Patients With Alcohol Use Disorder

Acronym: QUALIFACT

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Feb 10, 2021
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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