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Clinical Trials/NCT02364817
NCT02364817CompletedNot Applicable

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

University Hospital, Lille2 sites in 1 country113 target enrollmentStarted: January 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
113
Locations
2
Primary Endpoint
Cumulated rate of alcohol relapse

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Cumulated rate of alcohol relapse

Time Frame: 12 weeks

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

Secondary Outcomes

  • Psychometric properties of the ASRS(12 weeks)
  • Multivariate analysis of the alcohol relapse(12 weeks)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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