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

Alcoholism Clinical Trial

— AGADIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02364817
• Other study ID #: 2013_09
• Secondary ID: 2014-A00132-45
• Status: Recruiting
• Start date: January 2015
• Est. completion date: February 2020

Study information

• Verified date: August 2019
• Source: University Hospital, Lille
• Contact: Benjamin ROLLAND, MD, PhD
• Phone: +33 320 445 838
• Email: benjamin.rolland[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism
• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
France	Department of Addiction Medicine	Lille
France	Department of Addiction Medicine	Saint-Amand-les-Eaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Institute for Scientific Research on Beverages (France)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulated rate of alcohol relapse	Cumulated rate of alcohol relapse during the 12 weeks following the detoxification program	12 weeks
Secondary	Psychometric properties of the ASRS	Psychometric properties of the ASRS by comparison with the DIVA 2.0 and the screening of differential diagnoses	12 weeks
Secondary	Multivariate analysis of the alcohol relapse	Multivariate analysis of the cumulated rate of alcohol relapse during the 12 weeks following the detoxification program	12 weeks