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

NCT ID: NCT02364817

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcoholism Attention Deficit Disorder With Hyperactivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

cognitive and psychiatric assessment

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cognitive and psychiatric assessment

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institute for Scientific Research on Beverages (France)

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Renaud Jardri, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Lille (CHU Lille), France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ch Le Vinatier

Bron, , France

Site Status

Department of Addiction Medicine

Lille, , France

Site Status

Department of Addiction Medicine

Saint-Amand-les-Eaux, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-A00132-45

Identifier Type: OTHER

Identifier Source: secondary_id

2013_09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Impulsivity Domains and Subjective Response
NCT05929677 RECRUITING EARLY_PHASE1
New Relapse Model in Psychiatry
NCT06244641 RECRUITING NA
Neurofeedback & Alcohol Dependence
NCT02486900 COMPLETED NA