Attention Deficit Hyperactivity DisorderADANCT06232226
Attention Deficit Hyperactivity Disorder
A study testing Patients suffering from the co-occurrence of ADHD and addiction(s) in people with Attention Deficit Hyperactivity Disorder and Behavior Hyperactive, run by Nantes University Hospital at 3 sites in France.
Trial summary
The ADA cohort aims for the systematic and standardized collection of sociodemographic, clinical and neuropsychological data, during 2 visits (inclusion and 12 months), from patients suffering from the co-occurrence of ADHD (Attention Deficit Hyperactivity Disorder) and addiction(s), in addition to the treatment as… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Behavior Hyperactive, Behavior Disorders
- What is being tested?
- Patients suffering from the co-occurrence of ADHD and addiction(s)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years
- For whom a diagnosis of ADHD has been confirmed less than 12 weeks ago
- For whom the diagnosis of one or more addictive disorder(s) (substance use disorder or behavioral addiction) has been confirmed
- Meeting the indication for treatment with MPH according to European recommendations (Kooij et al., 2019)
- For patients who can actually benefit from MPH: who have not yet started taking MPH
- Social security affiliates
Who cannot join
- Presenting disorders of higher cognitive functions (at the discretion of the referring clinician or the investigator making the inclusion), making data collection impossible
- Presenting difficulties in reading or writing the French language making data collection impossible
- Unable to commit to being available for the 2 visits planned as part of the cohort
- Under guardianship or legal protection
- Patients who have used psychoactive substances within 12 hours prior to their visit
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHRU de Brest
Brest, 29000
Morgane Guillou-Landreat, PH, morgane.guillou@chu-brest.fr
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
Clémence CABELGUEN, PH, 33 2 40 84 61 16, clemence.cabelguen@chu-nantes.fr
Gaelle CHALLET, 33 2 53 48 25 32, gaelle.challet@chu-nantes.fr
- Recruiting
CHRU de Tours
Tours, 37000
Paul Brunault, PH, paul.brunault@univ-tours.fr
About this study
Official title: Addictions and Attention Deficit Disorder With or Without Hyperactivity
The ADA cohort aims for the systematic and standardized collection of sociodemographic, clinical and neuropsychological data, during 2 visits (inclusion and 12 months), from patients suffering from the co-occurrence of ADHD (Attention Deficit Hyperactivity Disorder) and addiction(s), in addition to the treatment as usual adapted to each situation.
Read the detailed description
Information on the study and diagnosis of ADHD will be carried out during a medical evaluation consultation, as part of routine care.
The two research visits (inclusion and at 12 months) will be added by the research and will each include:
- A structured clinical interview with a research professional (traceability of oral consent, administration of structured interviews, collection of self-questionnaires, collection of care from the medical record)
- A neuropsychological assessment with a neuropsychologist
- Being tested
- Patients suffering from the co-occurrence of ADHD and addiction(s)
- Keywords
- Attention Deficit Disorder with Hyperactivity, Addictive disorders, Neuropsychology, Methylphenidate, Atomoxetine, Functional impairment, Symptoms
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients suffering from the co-occurrence of ADHD and addiction(s)Other
All eligible patients over 18 years, presenting both a diagnosis of ADHD and a diagnosis of at least one addictive disorder (SUD, AUD (Alcohol Use Disorder) and/ or behavioral addiction), starting care in one of the three participating centers, and meeting the indication for treatment with MPH according to European recommendations (J. J. S. Kooij et al., 2019)
| Study group | Role | What they receive |
|---|---|---|
| Neuropsychological assessment | Other | Determination of the neuropsychological profile Receives: Other: Patients suffering from the co-occurrence of ADHD and addiction(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional impairment
Weiss Functional Impairment Rating Scale (WFIRS-S) (scores of the 7 domains and total score)
Measured: Inclusion and 12-month follow-up
Secondary outcomes (21)
Type and severity of ADHD
Diagnostiscal Interview Voor Attention deficit hyperactivity disorder (DIVA-5)
Measured: Inclusion
Symptoms of ADHD
Adult ADHD Self-Report Scale Symptom Checklist (ASRS-1.1) (inattention and hyperactivity/impulsivity scores)
Measured: Inclusion and 12-month follow-up
Addictive disorders - substance use disorders (including tobacco, alcohol and other substances)
Mini International Neuropsychiatric Interview- Simplified for Diagnostic and Statistical Manual (DSM)-5 (MINI-S)
Measured: Inclusion and 12-month follow-up
Addictive disorders - gambling disorder
National Opinion research center DSM Screen for gambling problems (NODS)
Measured: Inclusion and 12-month follow-up
Addictive disorders - sex addiction
Structured interview adapted from the NODS to explore the diagnostic criteria proposed by Carnes et al in 2012
Measured: Inclusion and 12-month follow-up
Addictive disorders - gambling disorder
Structured interview adapted from the NODS to explore the diagnostic criteria proposed in the third section of the DSM-5 for the Internet gaming disorder
Measured: Inclusion and 12-month follow-up
Addictive disorders - eating addiction
Yale Food Addiction Scale (YFAS 2.0)
Measured: Inclusion and 12-month follow-up
Psychiatric disorders
MINI-S
Measured: Inclusion and 12-month follow-up
Neuropsychological profile - selective attention
D2-R test (CCT standard score, E% standard score and CC standard score)
Measured: Inclusion and 12-month follow-up
Neuropsychological profile - short-term and working memory
Digit memory test (standardized scores of numbers of items correctly recalled (direct order, indirect order, ascending order, total), span sizes (direct order, indirect order, ascending order))
Measured: Inclusion and 12-month follow-up
Neuropsychological profile - inhibition
Stroop test (standardized execution times (naming condition, interference condition), standardized numbers of uncorrected errors (naming condition, interference condition), and standardized interference score)
Measured: Inclusion and 12-month follow-up
Neuropsychological profile - spontaneous flexibility
Verbal fluency test (standardized scores for the number of words cited and the number of errors, in both conditions (literal and categorical))
Measured: Inclusion and 12-month follow-up
Neuropsychological profile - planning
Zoo test (total profile score)
Measured: Inclusion and 12-month follow-up
Psychopathological profile - impulsivity
Urgency, Premeditation (lack of), Perseverance (lack of), Sensation seeking impulsivity behavior scale (UPPS-P) (5 scores)
Measured: Inclusion and 12-month follow-up
Psychopathological profile - emotional dysregulation
Difficulties in Emotion Regulation Scale (DERS-16) (5 scores and total score)
Measured: Inclusion and 12-month follow-up
Psychopathological profile - sensorial profile
Sensory profile of Winnie Dunn - adult version (category and raw scores in the 4 quadrants)
Measured: Inclusion and 12-month follow-up
Psychopathological profile - self-esteem
Rosenberg Self-Esteem Scale (RSES) (total score)
Measured: Inclusion and 12-month follow-up
Quality of life survey
World Health Organization Quality Of Life (WHOQoL-26) (4 scores)
Measured: Inclusion and 12-month follow-up
Care received
Effective implementation of treatment with MPH (yes/no) or atomoxetine (yes/no), If no, reasons for not implementing it (for MPH), Care provided (Cognitive remediation / behavioral and cognitive therapy / psychoeducation / other psychosocial intervention (details) / other drug treatment), Reported compliance and misuse for MPH and atomoxetine, Reported compliance for non-drug care, Tolerance: numerical scale from 0 to 10 for the evaluation of the main adverse effects (for MPH and for atomoxetine).
Measured: 12-month follow-up
Personal and family medical history
List of somatic, psychiatric and addictive disorders for personal history, list of psychiatric and addictive disorders for family history
Measured: Inclusion
Sociodemographics
Age, gender, level of education, professional status, number of children
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start11 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232226
- Sponsor's protocol ID
- RC23_0074
- Acronym
- ADA
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2024
- Last updated
- 17 Apr 2026
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addictions and Attention Deficit Disorder With or Without Hyperactivity
- ClinicalTrials.gov ID
- NCT06232226
- Acronym / sponsor ID
- ADA / RC23_0074
- Keywords
- Attention Deficit Disorder with Hyperactivity, Addictive disorders, Neuropsychology, Methylphenidate, Atomoxetine, Functional impairment, Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2024 (actual)
- 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.
The ADA cohort aims for the systematic and standardized collection of sociodemographic, clinical and neuropsychological data, during 2 visits (inclusion and 12 months), from patients suffering from the co-occurrence of ADHD (Attention Deficit Hyperactivity Disorder) and addiction(s), in addition to the treatment as usual adapted to each situation.
Detailed description
Information on the study and diagnosis of ADHD will be carried out during a medical evaluation consultation, as part of routine care.
The two research visits (inclusion and at 12 months) will be added by the research and will each include:
- A structured clinical interview with a research professional (traceability of oral consent, administration of structured interviews, collection of self-questionnaires, collection of care from the medical record)
- A neuropsychological assessment with a neuropsychologist
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort
| Arm | Type | Receives |
|---|---|---|
| Neuropsychological assessment | Other | Other: Patients suffering from the co-occurrence of ADHD and addiction(s)Determination of the neuropsychological profile |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged over 18 years
- For whom a diagnosis of ADHD has been confirmed less than 12 weeks ago
- For whom the diagnosis of one or more addictive disorder(s) (substance use disorder or behavioral addiction) has been confirmed
- Meeting the indication for treatment with MPH according to European recommendations (Kooij et al., 2019)
- For patients who can actually benefit from MPH: who have not yet started taking MPH
Key exclusion criteria (5 listed)
- Presenting disorders of higher cognitive functions (at the discretion of the referring clinician or the investigator making the inclusion), making data collection impossible
- Presenting difficulties in reading or writing the French language making data collection impossible
- Unable to commit to being available for the 2 visits planned as part of the cohort
- Under guardianship or legal protection
- Patients who have used psychoactive substances within 12 hours prior to their visit
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 |
|---|---|---|
| Patients suffering from the co-occurrence of ADHD and addiction(s)All eligible patients over 18 years, presenting both a diagnosis of ADHD and a diagnosis of at least one addictive disorder (SUD, AUD (Alcohol Use Disorder) and/ or behavioral addiction), starting care in one of the three participating centers, and meeting the indication for treatment with MPH according to European recommendations (J. J. S. Kooij et al., 2019) | Other | Neuropsychological assessment |
Primary outcome
Functional impairment
Time frame: Inclusion and 12-month follow-up
Weiss Functional Impairment Rating Scale (WFIRS-S) (scores of the 7 domains and total score)
21 secondary outcomes
Type and severity of ADHD
Time frame: Inclusion
Symptoms of ADHD
Time frame: Inclusion and 12-month follow-up
Addictive disorders - substance use disorders (including tobacco, alcohol and other substances)
Time frame: Inclusion and 12-month follow-up
Addictive disorders - gambling disorder
Time frame: Inclusion and 12-month follow-up
Addictive disorders - sex addiction
Time frame: Inclusion and 12-month follow-up
Addictive disorders - gambling disorder
Time frame: Inclusion and 12-month follow-up
Addictive disorders - eating addiction
Time frame: Inclusion and 12-month follow-up
Psychiatric disorders
Time frame: Inclusion and 12-month follow-up
Neuropsychological profile - selective attention
Time frame: Inclusion and 12-month follow-up
Neuropsychological profile - short-term and working memory
Time frame: Inclusion and 12-month follow-up
Neuropsychological profile - inhibition
Time frame: Inclusion and 12-month follow-up
Neuropsychological profile - spontaneous flexibility
Time frame: Inclusion and 12-month follow-up
Neuropsychological profile - planning
Time frame: Inclusion and 12-month follow-up
Psychopathological profile - impulsivity
Time frame: Inclusion and 12-month follow-up
Psychopathological profile - emotional dysregulation
Time frame: Inclusion and 12-month follow-up
Psychopathological profile - sensorial profile
Time frame: Inclusion and 12-month follow-up
Psychopathological profile - self-esteem
Time frame: Inclusion and 12-month follow-up
Quality of life survey
Time frame: Inclusion and 12-month follow-up
Care received
Time frame: 12-month follow-up
Personal and family medical history
Time frame: Inclusion
Sociodemographics
Time frame: Inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients suffering from the co-occurrence of ADHD and addiction(s) in people with Attention Deficit Hyperactivity Disorder and Behavior Hyperactive, run by Nantes University Hospital 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clémence CABELGUEN, PH (33 2 40 84 61 16, clemence.cabelguen@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional impairment (time frame: Inclusion and 12-month follow-up). 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 17 Apr 2026.