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

• Conditions: Attention Deficit Disorder With Hyperactivity; Alcoholism
• Interventions: Behavioral: cognitive and psychiatric assessment

• Registration Number: NCT02364817
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-05
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Detox Cohort	cognitive and psychiatric assessment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Psychometric properties of the ASRS	12 weeks	Psychometric properties of the ASRS by comparison with the DIVA 2.0 and the screening of differential diagnoses
Multivariate analysis of the alcohol relapse	12 weeks	Multivariate analysis of the cumulated rate of alcohol relapse during the 12 weeks following the detoxification program

Trial Locations

Locations (1)

Department of Addiction Medicine; 🇫🇷 Saint-Amand-les-Eaux, France