E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Brain functioning during THC intoxication |
|
E.1.1.1 | Medical condition in easily understood language |
Brain functioning during THC intoxication |
|
E.1.1.2 | Therapeutic area | Not possible to specify |
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 |
In this study, we want to know more about the acute effects of cannabis on neurotransmitter systems. For this, we compare the effects of cannabis with the effects of placebo in 30 occasional and 20 chronic cannabis users. During and after the administration of cannabis and placebo, the acute changes in brain chemicals will be mapped by means of brain scans. |
|
E.2.2 | Secondary objectives of the trial |
Brain functioning during intoxication will be related to THC kinetics and subjective drug experience |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Occasional cannabis users: Used cannabis between 1 times a month and 1 times a week during the previous year
Chronic cannabis users: Used cannabis at least 3 times/week during the previous year
Age between 18 and 40 years
Free from psychotropic medication
Good physical health as determined by medical examination and laboratory analysis
Absence of any major medical, endocrine and neurological condition
Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2
|
|
E.4 | Principal exclusion criteria |
History of drug abuse (other than the use of cannabis) or addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
Pregnancy or lactation
Hypertension (diastolic> 90; systolic> 140)
Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
Liver dysfunction
(Serious) side effects to previous cannabis or alcohol use
History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…)
For women: no use of a reliable contraceptive
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Neurotransmission of dopamine, glutamate and GABA.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
When completed by all subjects |
|
E.5.2 | Secondary end point(s) |
THC kinetics
subjective drug experience |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
When completed by all subjects |
|
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Neurotransmission measured with MRS |
|
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 | Yes |
E.8.1.7.1 | Other trial design description |
Between group: Occasional cannabis users will be compared with chronic users |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |