Attention Deficit Hyperactivity Disorder (ADA)

April 14, 2026 updated by: Nantes University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Inclusion and 12-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Inclusion and 12-month follow-up
Addictive disorders - gambling disorder
Time Frame: Inclusion and 12-month follow-up
National Opinion research center DSM Screen for gambling problems (NODS)
Inclusion and 12-month follow-up
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
Inclusion and 12-month follow-up
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
Inclusion and 12-month follow-up
Addictive disorders - eating addiction
Time Frame: Inclusion and 12-month follow-up
Yale Food Addiction Scale (YFAS 2.0)
Inclusion and 12-month follow-up
Psychiatric disorders
Time Frame: Inclusion and 12-month follow-up
MINI-S
Inclusion and 12-month follow-up
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)
Inclusion and 12-month follow-up
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))
Inclusion and 12-month follow-up
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)
Inclusion and 12-month follow-up
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))
Inclusion and 12-month follow-up
Neuropsychological profile - planning
Time Frame: Inclusion and 12-month follow-up
Zoo test (total profile score)
Inclusion and 12-month follow-up
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)
Inclusion and 12-month follow-up
Psychopathological profile - emotional dysregulation
Time Frame: Inclusion and 12-month follow-up
Difficulties in Emotion Regulation Scale (DERS-16) (5 scores and total score)
Inclusion and 12-month follow-up
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)
Inclusion and 12-month follow-up
Psychopathological profile - self-esteem
Time Frame: Inclusion and 12-month follow-up
Rosenberg Self-Esteem Scale (RSES) (total score)
Inclusion and 12-month follow-up
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).
12-month follow-up
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
Inclusion
Sociodemographics
Time Frame: Inclusion
Age, gender, level of education, professional status, number of children
Inclusion
Type and severity of ADHD
Time Frame: Inclusion
Diagnostiscal Interview Voor Attention deficit hyperactivity disorder (DIVA-5)
Inclusion
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)
Inclusion and 12-month follow-up
Quality of life survey
Time Frame: Inclusion and 12-month follow-up
World Health Organization Quality Of Life (WHOQoL-26) (4 scores)
Inclusion and 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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