Brain functioning during THC intoxication
Conditions
Interventions
Trade Name: Bedrobinol
Pharmaceutical Form: Inhalation vapour
Pharmaceutical form of the placebo: Inhalation vapour
Route of administration of the placebo: Inhalation use
Sponsors
Maastriccht University
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Brain functioning during intoxication will be related to THC kinetics and subjective drug experience;Primary end point(s): Neurotransmission of dopamine, glutamate and GABA. ;Timepoint(s) of evaluation of this end point: When completed by all subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): THC kinetics subjective drug experience;Timepoint(s) of evaluation of this end point: When completed by all subjects | — |
Countries
Netherlands
Contacts
Public ContactE.L. Theunissen
Maastricht University
Outcome results
None listed