E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
It is not really a medical condition that is being investigated.
The present research proposal has been designed 1) to assess creativity during cocaine intoxication, and 2) to define the potentially different effect of cocaine on divergent and convergent thinking in cocaine users |
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E.1.1.1 | Medical condition in easily understood language |
It is not really a medical condition that is being investigated.
We try to investigate the effect of cocaine on creativity when people are under the influence of cocaine. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Psychological processes [F02] |
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 |
The present research proposal has been designed 1) to assess creativity during cocaine intoxication, and 2) to define the potentially different effect of cocaine on divergent and convergent thinking in cocaine users |
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E.2.2 | Secondary objectives of the trial |
We want to investigate the link between cocaine administration and fear recognition. We expect to find impairment of fear recognition after acute cocaine administration compared to placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- subjects must have used cocaine on at least 12 separate occasions during the past two years;
- good physical and mental health as determined by medical history and medical, ECG and laboratory examination;
- body weight between 80 and 130% of the ideal bodyweight as defined in the Metropolitan Life Insurance tables;
- use of appropriate contraception,
- written informed consent;
- age 18-40
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E.4 | Principal exclusion criteria |
- pregnancy or lactation;
- cardiovascular abnormalities as assessed by standard ECG;
- excessive drinking;
- hypertension;
- history of psychiatric and neurological disorders
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E.5 End points |
E.5.1 | Primary end point(s) |
The study will comprise measures of divergent and convergent thinking, fear recognition, drug concentrations, hormones, questionnaires, heart rate and blood pressure.
Primary endpoints will be measures of divergent and convergent thinking. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Each test day (gather the information); at the end of the study, merge all this information and do analyses |
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E.5.2 | Secondary end point(s) |
The study will comprise measures of divergent and convergent thinking, fear recognition, drug concentrations, hormones, questionnaires, heart rate and blood pressure. Secondary endpoints will be questionnaires and fear recognition parameters. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Each test day (gather the information); at the end of the study, merge all this information and do analyses |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
The influence of cocaine on creativity |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | 2 |
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 | 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
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Study termination is defined as a permanent discontinuation of the study due to unanticipated concerns of safety to the subjects or otherwise LVLS. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |