E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This research project will be performed with healthy volunteers in order to determine whether THC modulates activity in functional brain systems. |
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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 | 10007171 |
E.1.2 | Term | Cannabis abuse |
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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 whether THC modulates activity in functional brain systems. We test this by assessing the acute effects of THC on the reward system, the working memory system and the associative memory system. |
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E.2.2 | Secondary objectives of the trial |
• To determine the acute behavioral and physiological effects induced by THC. • To investigate the relationship between plasma THC, activational pattern and behavioral data using PK/PD modeling. • To investigate functional and effective connectivity between brain regions activated by THC.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• History of mild cannabis use for at least one year (<1/week and ≥ 4/year) • History without psychotic experiences after cannabis use • Age between 18 and 45 years • Right-handedness, assessed with the Edinburgh Handedness Inventory (Oldfield, 1971 • Written informed consent of the subject
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E.4 | Principal exclusion criteria |
• Any clinical significant abnormality of any clinical laboratory test, including urinary drug screening • Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests (see paragraph 8.3.1) • History of clinically significant psychiatric or neurological illness • History of clinically significant psychiatric or neurological illness in first- or second-degree relatives • History of alcohol and/or drug abuse (DSM-IV criteria) • Body Mass Index (B.M.I.) between 18 and 28 kg/m2 • Paranoid ideation or psychoticism on SCL-90 • Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug • The use of any medication within three weeks prior to the start of the study, except for paracetamol • Positive HIV or Hepatitis B/C test • Blood donation within 3 months before the start of the study • Claustrophobia • Metal objects in or around the body (braces, pacemaker, metal fragments)
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E.5 End points |
E.5.1 | Primary end point(s) |
The investigator can decide to withdraw a subject from the study. This can be due to medical reasons, for example when serious side effects occur, or when subjects need procedures that are not allowed in the protocol. In case of repeated withdrawal of subjects for urgent medical reasons, the investigator will decide to end the study prematurely. |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | 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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |