Adding cognitive training to methylphenidate for adults with ADHD and addiction

MEthylphenidate in ADHD - Addiction(s) Comorbidity: Value of Adding a Cognitive Remediation Program to Improve Short- and Medium-term Therapeutic Response

This study tests whether adding a cognitive training program to methylphenidate helps adults with ADHD and addiction improve day-to-day functioning.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 248 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 6 sites (Brest, Brittany Region and 5 other locations)
• Trial ID: NCT06906328 on ClinicalTrials.gov

What this trial studies

Adults diagnosed with ADHD and at least one addictive disorder who are appropriate for methylphenidate receive standard MPH treatment and are assigned to either an intensive cognitive remediation program using PRESCO® or a control program using AUDITICO®. The intervention combines repeated cognitive exercises targeting deficient functions with training in compensatory strategies. Functional outcomes are measured at the end of treatment and in the medium term using clinical and objective assessments. The multicenter study is conducted at several French hospital sites and requires in-person participation for the training sessions and assessments.

Who should consider this trial

Good fit: Adults (18+) with ADHD confirmed by DIVA-5, an indication for methylphenidate, at least one addictive disorder, and French social security coverage are the intended participants.

Not a fit: People who are pregnant or breastfeeding, deprived of liberty or under compulsory psychiatric care, have severe cognitive or French language barriers, or are enrolled in another conflicting interventional study are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, adding cognitive remediation could yield better and more durable improvements in daily functioning than medication alone for adults with ADHD and addiction.

How similar studies have performed: Cognitive training has shown benefits mainly in children with ADHD, but evidence in adults—especially those with comorbid addiction—is limited and the approach remains relatively untested in this population.

Eligibility criteria

Inclusion Criteria:

* Age over 18;
* Diagnosis of ADHD confirmed by DIVA-5 interview following a specialized ADHD-addiction(s) consultation;
* Indication for MPH treatment according to European recommendations (J. J. S. Kooij et al., 2019) and absence of contraindications (particularly cardiological);
* Presence of at least one comorbid addictive disorder (SUD and/or BA);
* Having given their consent to take part in the study;
* Being affiliated to the French social security system or benefiting from such a system.

Exclusion Criteria:

* Presence of disorders of the higher functions or difficulties in reading or writing the French language making it impossible to collect data;
* Pregnant or breast-feeding woman;
* Person deprived of liberty;
* Person under compulsory psychiatric care;
* Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical outcome;
* Guardianship or safeguard of justice.
* Patients who consumned psychoactive substances within 12 hours prior to their visit.

Where this trial is running

Brest, Brittany Region and 5 other locations

• CHRU Brest — Brest, Brittany Region, France (Not_yet_recruiting)
• EPSM du Finistère Sud — Quimper, Brittany Region, France (Not_yet_recruiting)
• EPSM Georges Daumézon (Fleury-les-Aubrais, Loiret) — Fleury-les-Aubrais, Centre-Val de Loire, France (Not_yet_recruiting)
• CHRU de Tours — Tours, Centre-Val de Loire, France (Not_yet_recruiting)
• CH Georges Daumézon - Bouguenais — Bouguenais, Loire-Atlantique, France (Not_yet_recruiting)
• CHU Nantes — Nantes, France (Recruiting)

Study contacts

• Study coordinator: Clémence Dr Cabelguen, MD-Phd

Conditions ADHD-add; Methylphenidate; Cognitive remediation; Functional improvement