NCT02364817

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

February 10, 2015

Last Update Submit

December 8, 2025

Conditions

Keywords

Attention Deficit Disorder with HyperactivityAlcohol DependenceAdultsTreatment outcomeMental Health

Outcome Measures

Primary Outcomes (1)

  • Cumulated rate of alcohol relapse

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

    12 weeks

Secondary Outcomes (2)

  • Psychometric properties of the ASRS

    12 weeks

  • Multivariate analysis of the alcohol relapse

    12 weeks

Study Arms (1)

Post-Detox Cohort

All the patients included should meet Diagnostic and Statistical Manual 4th edition revised (DSM-IV-Tr) criteria for Alcohol Dependance. They are all recruited at the end of an inpatient alcohol detoxification process (see inclusion criteria). The initial screening is performed just before the end of hospitalization. The subsequent follow-up is 12 weeks-long. There is no drug for abstinence maintenance during the study. The psychosocial intervention is based on the BRENDA model.

Behavioral: cognitive and psychiatric assessment

Interventions

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

Post-Detox Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with alcohol-dependence who undergo a residential alcohol detoxification program

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ch Le Vinatier

Bron, France

Location

Department of Addiction Medicine

Lille, 59037, France

Location

Department of Addiction Medicine

Saint-Amand-les-Eaux, 59230, France

Location

MeSH Terms

Conditions

AlcoholismAttention Deficit Disorder with HyperactivityPsychological Well-Being

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersPersonal SatisfactionBehavior

Study Officials

  • Renaud Jardri, MD, PhD

    University Hospital of Lille (CHU Lille), France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 18, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations