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Completed

NCT Number: NCT02364817

ADHD: Gaps Between Patients With Alcohol-dependence and Impact on Relapse

Some recent studies have found that adult attention deficit - hyperactivity disorder (ADHD) was frequent among patients with alcohol-dependence. However, no investigation has ever addressed whether ADHD may impact the drinking outcome.

Moreover, most of the different aforementioned studies assessed ADHD using the ADHD self-report scale (ASRS). The ASRS is a screening questionnaire that is of limited diagnostic value, and the overrepresentation of high-score ASRS among patients with alcohol-dependence could be in part due to differential diagnoses such as antisocial or borderline personality disorders, executive function impairments, or isolated impulsiveness.

The study aims to evaluate "ADHD: Gaps between patients with Alcohol Dependence and Impact on early Relapse" (AGADIR). In AGADIR, subjects with alcohol-dependence are recruited at the end of a residential detoxification program. They are assessed for ADHD using the ASRS, but also with a standardized diagnostic tool, i.e., the Diagnostic Interview for ADHD in adults (DIVA 2.0). Potential differential diagnoses are screened during the baseline visit. The patients are followed-up during the 12 first post-detox weeks, through a standardized psychosocial treatment. ASRS is re-performed at the end of the follow-up.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch Le Vinatier, Bron, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • current DSM-IV-Tr criteria for alcohol-dependence
  • current residential alcohol detoxification program

Non-inclusion Criteria:

  • concurrent alcohol withdrawal symptoms, i.e., CIWA-Ar ≥ 10
  • benzodiazepine diazepam-equivalent dose > 30 mg
  • medical history of neurological impairment (excluding alcohol-induced cognitive disorders)
  • guardianship or loss of liberty
  • pregnant or lactating woman

Treatment and study plan

cognitive and psychiatric assessment

Behavioral

Administered at baseline:

  • Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar)
  • hyperactivity : Adult ADHD Self-Report Scale (ASRS), Wenders-Utah Rating Scale (WURS), Diagnostic Interview for Adult ADHD 2nd edition (DIVA 2.0)
  • psychiatric history : Mini International Neuropsychiatric Interview 5th edition (MINI 5.0), Personality Disorder Questionnaire for the DSM-IV (PDQ-4)
  • cognitive functions : Frontal Assessment Battery (FAB), Montreal Cognitive Assessment (MoCA)
  • impulsivity : Barratt's Impulsiveness scale 11th edition (BIS-11)
  • alcohol consumption: alcohol - timeline follow-back (A-TLFB) ,administered at baseline (month before hospitalization), week 4 visit, week 6 visit, and week 12 visit.
  • administered at week 12: ASRS

Primary outcomes

  1. Cumulated rate of alcohol relapse

    Time frame: 12 weeks

    Cumulated rate of alcohol relapse during the 12 weeks following the detoxification program

Secondary outcomes

  1. Psychometric properties of the ASRS

    Time frame: 12 weeks

    Psychometric properties of the ASRS by comparison with the DIVA 2.0 and the screening of differential diagnoses

  2. Multivariate analysis of the alcohol relapse

    Time frame: 12 weeks

    Multivariate analysis of the cumulated rate of alcohol relapse during the 12 weeks following the detoxification program

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Institute for Scientific Research on Beverages (France)

Registry information

Official study title

Impact of Attention Deficit/Hyperactivity Disorder on the Post-detoxification Alcohol Relapse Rate

Acronym: AGADIR

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 18, 2015
Registry last updated
Dec 16, 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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