E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Patients who fulfil DSMIV/5 criteria for amphetamine dependence |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To better understand the effect and the mechanism of MPH in this population we aim to study the medication effect on impulse inhibition and other executive functioning –some of the core deficits in both ADHD and in SUD.
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E.2.2 | Secondary objectives of the trial |
In order to study the dose response relationship for MPH, plasma concentrations will be monitored.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or a non-pregnant/non-nursing female between 18 and 55 years of age • Fulfills DSM-IV/DSM-5 criteria for amphetamine dependence * Fulfills DSM-IV/DSM-5 criteria for ADHD • Minimum 7 maximum 90 amphetamine-free days before inclusion • IQ estimate > 75 • Signed informed consent • Be willing to comply with study protocol
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E.4 | Principal exclusion criteria |
• Current use of any psychoactive medication • Fulfills DSM-IV diagnosis of any other substance dependence disorder (except nicotine) the past 6 month period before inclusion • Fulfills DSM-IV/DSM-5 diagnosis of any major psychiatric illness e.g. schizophrenia, bipolar disorder, and major depression • Tourette’s syndrome • Presence of any serious somatic disorder (e.g. heart condition, stroke) • Use of any illegal drugs for the last 7 days. • Presence of drug of abuse in urine at inclusion
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E.5 End points |
E.5.1 | Primary end point(s) |
• Effect of 180 mg of methylphenidate on impulsivity compared to no medication at baseline: measured as Stop Signal Reaction Time and Spatial Working Memory in CANTAB. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Effect of 180mg of methylphenidate on impulsivity, processing speed and attention compared to baseline: measured with cognitive tests in CANTAB and with AQT • Effect of 72 mg on impulsivity, spatial working memory, processing speed and attention compared to baseline: measured with cognitive tests in CANTAB and with AQT. • ADHD symptoms measured with self-rating scale ASRS/ CAARS • Hyperactivity measured with Qb+ Test • Craving measured with VAS-scale • Adverse Events (questionnaire) • Depression measured with Montgomery- Asberg Depression Rating Scale (MADRS) • Psychiatric symptoms measured by Outcome Questionnaire 45 • Life time alcohol and amphetamine use measured by adapted Life time drinking history (LDH) • Comparison of results in CANTAB between individuals with ADHD+ SUD and with ADHD - SUD at 72 mg |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |