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

Phase 1

• Conditions: Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; ADHD

• Registration Number: EUCTR2013-002720-16-SE
• Lead Sponsor: Stockholms Läns Sjukvårdsområde (SLSO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-25
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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

No study-specific exclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>;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 Outcome Measures

Name	Time	Method
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 <br><br>;Timepoint(s) of evaluation of this end point: Visit 1 Pharmacogenetic blood sample<br><br><br>