EMPHAS I Evaluation of Methylphenidate in adults with ADHD and Substance Use Disorder

EMPHAS I Evaluation of Methylphenidate (MPH) in adults with ADHD and SUD - clinical pharmacology study A Cross-sectional, Open-label, Non-randomized Single-Center Study on Adults with ADHD and Substance Use Disorder (SUD) Treated with Methylphenidate in Routine Clinical Practice. - EMPHAS I

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002720-16-SE

Enrollment

200

Registered

2014-06-25

Start date

2014-10-08

Completion date

Unknown

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Interventions

Pharmaceutical Form: Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Adults (18-64 years) treated with MPH, with a minimum duration of 14 days at Beroendecentrum Stockholm. •Diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, DSM-IV or DSM-5. •Diagnosed with at least one non-nicotine substance use disorder according to the Diagnostic and Statistical Manual of Mental Diseases, DSM-IV or DSM-5. •Signed informed consent form indicating that they understood the purpose of and procedures required for the study and are willing to participate in the study •Patient is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: No study-specific exclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: To characterize the impact of genetic, environmental (e.g. smoking, concomitant use of drugs, narcotics, alcohol) and other factors such as gender, age, body weight and types of addiction on the inter- and intra-individual variability of plasma concentrations of MPH, its enantiomers and metabolites, and on dose requirement in adults with ADHD and comorbid SUD.;Secondary Objective: To explore the potential of a metabolomics approach using high resolution mass spectrometry (LC-HRMS) for simultaneous analysis of multiple drugs, metabolites and biomarkers in plasma. ;Primary end point(s): •Plasma concentrations of MPH, its enantiomers, metabolites and concomitant drugs;Timepoint(s) of evaluation of this end point: 2 bloodsamples will be collected Visit 1 to Visit 4 (one-two weeks interval)	—

Measure

Time frame

Main Objective: To characterize the impact of genetic, environmental (e.g. smoking, concomitant use of drugs, narcotics, alcohol) and other factors such as gender, age, body weight and types of addiction on the inter- and intra-individual variability of plasma concentrations of MPH, its enantiomers and metabolites, and on dose requirement in adults with ADHD and comorbid SUD.;Secondary Objective: To explore the potential of a metabolomics approach using high resolution mass spectrometry (LC-HRMS) for simultaneous analysis of multiple drugs, metabolites and biomarkers in plasma. ;Primary end point(s): •Plasma concentrations of MPH, its enantiomers, metabolites and concomitant drugs;Timepoint(s) of evaluation of this end point: 2 bloodsamples will be collected Visit 1 to Visit 4 (one-two weeks interval)

—

Secondary

Measure	Time frame
Secondary end point(s): •Genetic polymorphisms of candidate genes hypothesized to influence MPH effects for ADHD in adults with SUD and ADHD, treated with MPH ;Timepoint(s) of evaluation of this end point: Visit 1 Pharmacogenetic blood sample	—

Countries

Sweden

Contacts

Public ContactClinical Trials Information

Stockholms Läns Landsting, Beroendecentrum Stockholm

infoberoendecentrum@sll.se4608123 400 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026