E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ADHD with and without substance use disorder (SUD) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064104 |
E.1.2 | Term | ADHD |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009815 |
E.1.2 | Term | Cocaine addiction |
|
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 determine why methylphenidate is not successful in cocaine-dependent ADHD patients, using SPECT to comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male, age 18-60 years; 2. Current DSM-IV diagnosis of adult ADHD for all participants; 3. For the ADHD+SUD group: Current DSM-IV diagnosis of cocaine dependence, but abstinent from cocaine use for at least 1 week; 4. Able to provide written informed consent and to comply with all study procedures; 5. Negative urine analyses for MPH, amphetamines and cocaine.
|
|
E.4 | Principal exclusion criteria |
1. Currently dependent on any substance other than cocaine or nicotine; 2. History of severe depression, i.e. depression necessitating hospitalization, a history of 2 or more recurrent episodes of depression or previous suicide attempts; 3. Severe neurological or psychiatric disorders or diseases (e.g., psychosis, bipolar depression, Parkinson’s disease, or dementia) that require psychotropic medications; 4. Serious medical illnesses that would make participation hazardous, such as cardiovascular disease or ECG abnormalities; 5. Known hypersensitivity or allergy to MPH; 6. Under therapy with drug known to influence binding to DATs, including antipsychotics, MPH, bupropion, and dexamphetamine within 30 days prior to randomization; 7. Received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment; 8. Clinically significant abnormal laboratory values (≥3x normal) as measured by the treatment center; 9. Any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication. 10. Hypersensitivity to Iodine
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
To determine why methylphenidate is not successful in cocaine-dependent ADHD patients |
|
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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
study population ADHD without cocaine dependence |
|
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
| |
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 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |