ADHD: Gaps Between Patients With Alcohol-dependence and Impact on Relapse
AGADIR
Impact of Attention Deficit/Hyperactivity Disorder on the Post-detoxification Alcohol Relapse Rate
2 other identifiers
observational
113
1 country
3
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
Typical duration for all trials
3 active sites
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 Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 16, 2025
December 1, 2025
2.9 years
February 10, 2015
December 8, 2025
Conditions
Keywords
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.
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
Eligibility Criteria
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
Department of Addiction Medicine
Lille, 59037, France
Department of Addiction Medicine
Saint-Amand-les-Eaux, 59230, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renaud Jardri, MD, PhD
University Hospital of Lille (CHU Lille), France
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