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NCT Number: NCT06232226

Attention Deficit Hyperactivity Disorder

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Disorders Behavior Hyperactive Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital, Nantes, Loire-Atlantique, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

  1. 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)

Secondary outcomes

  1. Type and severity of ADHD

    Time frame: Inclusion

    Diagnostiscal Interview Voor Attention deficit hyperactivity disorder (DIVA-5)

  2. Symptoms of ADHD

    Time frame: Inclusion and 12-month follow-up

    Adult ADHD Self-Report Scale Symptom Checklist (ASRS-1.1) (inattention and hyperactivity/impulsivity scores)

  3. Addictive disorders - substance use disorders (including tobacco, alcohol and other substances)

    Time frame: Inclusion and 12-month follow-up

    Mini International Neuropsychiatric Interview- Simplified for Diagnostic and Statistical Manual (DSM)-5 (MINI-S)

  4. Addictive disorders - gambling disorder

    Time frame: Inclusion and 12-month follow-up

    National Opinion research center DSM Screen for gambling problems (NODS)

  5. Addictive disorders - sex addiction

    Time frame: Inclusion and 12-month follow-up

    Structured interview adapted from the NODS to explore the diagnostic criteria proposed by Carnes et al in 2012

  6. Addictive disorders - gambling disorder

    Time frame: Inclusion and 12-month follow-up

    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

  7. Addictive disorders - eating addiction

    Time frame: Inclusion and 12-month follow-up

    Yale Food Addiction Scale (YFAS 2.0)

  8. Psychiatric disorders

    Time frame: Inclusion and 12-month follow-up

    MINI-S

  9. Neuropsychological profile - selective attention

    Time frame: Inclusion and 12-month follow-up

    D2-R test (CCT standard score, E% standard score and CC standard score)

  10. Neuropsychological profile - short-term and working memory

    Time frame: Inclusion and 12-month follow-up

    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))

  11. Neuropsychological profile - inhibition

    Time frame: Inclusion and 12-month follow-up

    Stroop test (standardized execution times (naming condition, interference condition), standardized numbers of uncorrected errors (naming condition, interference condition), and standardized interference score)

  12. Neuropsychological profile - spontaneous flexibility

    Time frame: Inclusion and 12-month follow-up

    Verbal fluency test (standardized scores for the number of words cited and the number of errors, in both conditions (literal and categorical))

  13. Neuropsychological profile - planning

    Time frame: Inclusion and 12-month follow-up

    Zoo test (total profile score)

  14. Psychopathological profile - impulsivity

    Time frame: Inclusion and 12-month follow-up

    Urgency, Premeditation (lack of), Perseverance (lack of), Sensation seeking impulsivity behavior scale (UPPS-P) (5 scores)

  15. Psychopathological profile - emotional dysregulation

    Time frame: Inclusion and 12-month follow-up

    Difficulties in Emotion Regulation Scale (DERS-16) (5 scores and total score)

  16. Psychopathological profile - sensorial profile

    Time frame: Inclusion and 12-month follow-up

    Sensory profile of Winnie Dunn - adult version (category and raw scores in the 4 quadrants)

  17. Psychopathological profile - self-esteem

    Time frame: Inclusion and 12-month follow-up

    Rosenberg Self-Esteem Scale (RSES) (total score)

  18. Quality of life survey

    Time frame: Inclusion and 12-month follow-up

    World Health Organization Quality Of Life (WHOQoL-26) (4 scores)

  19. Care received

    Time frame: 12-month follow-up

    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).

  20. Personal and family medical history

    Time frame: Inclusion

    List of somatic, psychiatric and addictive disorders for personal history, list of psychiatric and addictive disorders for family history

  21. Sociodemographics

    Time frame: Inclusion

    Age, gender, level of education, professional status, number of children

Study contacts

Contact information is provided by the study sponsor or research team.

Clémence CABELGUEN, PH

CONTACT

[email protected]

33 2 40 84 61 16

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Addictions and Attention Deficit Disorder With or Without Hyperactivity

Acronym: ADA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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