AlcoholismAGADIRNCT02364817
ADHD: Gaps Between Patients With Alcohol-dependence and Impact on Relapse
An observational study of Alcoholism and Attention Deficit Disorder With Hyperactivity, run by University Hospital, Lille at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- cognitive and psychiatric assessment
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 113 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with alcohol-dependence who undergo a residential alcohol detoxification program
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Ch Le Vinatier
Bron
Department of Addiction Medicine
Lille, 59037
Department of Addiction Medicine
Saint-Amand-les-Eaux, 59230
About this study
Official title: Impact of Attention Deficit/Hyperactivity Disorder on the Post-detoxification Alcohol Relapse Rate
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.
- Being tested
- cognitive and psychiatric assessment
- Keywords
- Attention Deficit Disorder with Hyperactivity, Alcohol Dependence, Adults, Treatment outcome, Mental Health
- Medical subject headings
- Alcoholism, Attention Deficit Disorder with Hyperactivity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive and psychiatric assessmentBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: cognitive and psychiatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulated rate of alcohol relapse
Cumulated rate of alcohol relapse during the 12 weeks following the detoxification program
Measured: 12 weeks
Secondary outcomes (2)
Psychometric properties of the ASRS
Psychometric properties of the ASRS by comparison with the DIVA 2.0 and the screening of differential diagnoses
Measured: 12 weeks
Multivariate analysis of the alcohol relapse
Multivariate analysis of the cumulated rate of alcohol relapse during the 12 weeks following the detoxification program
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Scientific Research on Beverages (France)
- Responsible party
- Sponsor
- Investigators
- Renaud Jardri, MD, PhD, Principal investigator, University Hospital of Lille (CHU Lille), France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364817
- Sponsor's protocol ID
- 2013_09
- Other IDs
- 2014-A00132-45
- Acronym
- AGADIR
- Status last verified
- Dec 2025
- First submitted
- 10 Feb 2015
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Attention Deficit/Hyperactivity Disorder on the Post-detoxification Alcohol Relapse Rate
- ClinicalTrials.gov ID
- NCT02364817
- Acronym / sponsor ID
- AGADIR / 2013_09
- Keywords
- Attention Deficit Disorder with Hyperactivity, Alcohol Dependence, Adults, Treatment outcome, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Institute for Scientific Research on Beverages (France)
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Detox Cohort | – | Behavioral: cognitive and psychiatric assessmentAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with alcohol-dependence who undergo a residential alcohol detoxification program
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive and psychiatric assessmentAdministered 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 | Behavioural | Post-Detox Cohort |
Primary outcome
Cumulated rate of alcohol relapse
Time frame: 12 weeks
Cumulated rate of alcohol relapse during the 12 weeks following the detoxification program
2 secondary outcomes
Psychometric properties of the ASRS
Time frame: 12 weeks
Multivariate analysis of the alcohol relapse
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud Jardri, MD, PhD principal investigator
University Hospital of Lille (CHU Lille), France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism and Attention Deficit Disorder With Hyperactivity, run by University Hospital, Lille at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulated rate of alcohol relapse (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.