Attention Deficit Hyperactivity Disorder (ADA)

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.

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit Hyperactivity Disorder; Behavior Disorders; Behavior Hyperactive
• Intervention / Treatment: Other: Patients suffering from the co-occurrence of ADHD and addiction(s)

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clémence CABELGUEN, PH; Phone Number: 33 2 40 84 61 16; Email: clemence.cabelguen@chu-nantes.fr

Study Locations

• France
  • Brest, France, 29000
    • Recruiting
    • CHRU de Brest
    • Contact: Morgane Guillou-Landreat, PH; Email: morgane.guillou@chu-brest.fr
  • Tours, France, 37000
    • Recruiting
    • CHRU de TOURS
    • Contact: Paul Brunault, PH; Email: paul.brunault@univ-tours.fr
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Recruiting
      • Nantes University Hospital
      • Contact: Clémence CABELGUEN, PH; Phone Number: 33 2 40 84 61 16; Email: clemence.cabelguen@chu-nantes.fr
      • Contact: Gaelle CHALLET; Phone Number: 33 2 53 48 25 32; Email: gaelle.challet@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Neuropsychological assessment; Determination of the neuropsychological profile

Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional impairment	Weiss Functional Impairment Rating Scale (WFIRS-S) (scores of the 7 domains and total score)	Inclusion and 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of ADHD	Adult ADHD Self-Report Scale Symptom Checklist (ASRS-1.1) (inattention and hyperactivity/impulsivity scores)	Inclusion and 12-month follow-up
Addictive disorders - gambling disorder	National Opinion research center DSM Screen for gambling problems (NODS)	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	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	Inclusion and 12-month follow-up
Addictive disorders - eating addiction	Yale Food Addiction Scale (YFAS 2.0)	Inclusion and 12-month follow-up
Psychiatric disorders	MINI-S	Inclusion and 12-month follow-up
Neuropsychological profile - selective attention	D2-R test (CCT standard score, E% standard score and CC standard score)	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))	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)	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))	Inclusion and 12-month follow-up
Neuropsychological profile - planning	Zoo test (total profile score)	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)	Inclusion and 12-month follow-up
Psychopathological profile - emotional dysregulation	Difficulties in Emotion Regulation Scale (DERS-16) (5 scores and total score)	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)	Inclusion and 12-month follow-up
Psychopathological profile - self-esteem	Rosenberg Self-Esteem Scale (RSES) (total score)	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).	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	Inclusion
Sociodemographics	Age, gender, level of education, professional status, number of children	Inclusion
Type and severity of ADHD	Diagnostiscal Interview Voor Attention deficit hyperactivity disorder (DIVA-5)	Inclusion
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)	Inclusion and 12-month follow-up
Quality of life survey	World Health Organization Quality Of Life (WHOQoL-26) (4 scores)	Inclusion and 12-month follow-up

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Neuropsychology; Methylphenidate; Symptoms; Atomoxetine; Functional impairment; Attention Deficit Disorder with Hyperactivity; Addictive disorders
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mental Disorders; Attention Deficit Disorder with Hyperactivity; Spasm
• Other Study ID Numbers: RC23_0074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No