Clinical trial NCT02364817: ADHD: Gaps Between Patients With Alcohol-dependence and Impact on Relapse
Official title: Impact of Attention Deficit/Hyperactivity Disorder on the Post-detoxification Alcohol Relapse Rate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcoholism
Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Disorder with Hyperactivity
Alcohol Dependence
Adults
Treatment outcome
Mental Health
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institute for Scientific Research on Beverages (France)
First posted: 2015-02-18
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with alcohol-dependence who undergo a residential alcohol detoxification program

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cumulated rate of alcohol relapse
timeFrame: 12 weeks
Secondary outcomes:
measure: Psychometric properties of the ASRS
timeFrame: 12 weeks
measure: Multivariate analysis of the alcohol relapse
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: Department of Addiction Medicine
city: Saint-Amand-les-Eaux
country: France
facility: Department of Addiction Medicine
Study officials:
affiliation: University Hospital of Lille (CHU Lille), France
name: Renaud Jardri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: