Brain activation while using cannabis

Phase 1

• Conditions: Brain functioning during THC intoxication; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2014-002977-12-NL
• Lead Sponsor: Maastriccht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified