Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation

• Status: Completed
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of the study are 1) to know the concentrations of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) and other cannabinoids in blood, urine, oral fluid and sweat after the experimental administration of a standardized cannabis preparation orally (decoction and oil) and vaporized 2) to evaluate the pharmacological acute effects and tolerability

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Fundació Institut Germans Trias i Pujol; Istituto Superiore di Sanità

Criteria

Inclusion Criteria:

• Understanding and accepting the study procedures and signing the informed consent.

• Male and females healthy volunteers (18-45 years old.

• History and physical examination showing no organic or psychiatric disorders.

• The EKG and the blood chemistry and hematology at inclusion must be within the limits of normality. Minor or specific variations of the limits of normality are admitted if, in the opinion of the Principal Investigator, taking into account the state of science, they do not have clinical significance, do not pose a risk to the subjects and do not interfere with the evaluation of the product. These variations and their non-relevance will be specifically justified in writing.

• Body weight between 50-90 kilograms. Lower or higher weights are allowed, in the opinion of the Principal Investigator or the collaborators designated by him and that do not pose a risk to the subjects and do not interfere with the objectives of the study.

• BMI between 19-27 kg / m². Lower or higher BMIs are admitted, which in the opinion of the Principal Investigator or the collaborators designated by him that do not pose a risk to the subjects and do not interfere with the objectives of the study.

• Women with a menstrual cycle that lasts between 26-32 days and is regular.

• Subjects with social or recreational consumption of cannabis in the last 12 months and consumption of oral cannabis at least once in their life (eg cake, cookies, oils, infusion…).

Exclusion Criteria:

• Not meeting the inclusion criteria.

• History or clinical evidence of gastrointestinal, liver, kidney or other disorders that may involve an alteration in the absorption, distribution, metabolism or excretion of the drug, or that are suggestive of gastrointestinal irritation by drugs.

• Current or previous history of Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) substance use disorder (except nicotine and mild cannabis use disorder or DSM-IV for substance use disorder or abuse).

• Having donated blood in the previous 8 weeks, or having participated in clinical trials with drugs or nutraceuticals in the previous 12 weeks, except for having previously participated in this same study, in which a 3-week washout period is sufficient.

• Having suffered any organic disease or major surgery in the three months prior to the start of the study.

• Subjects who are intolerant or have had serious adverse reactions to cannabis.

• Having taken medication regularly in the month prior to the study sessions, with the exception of vitamins, herbal remedies or dietary supplements that, in the opinion of the Principal Investigator or the collaborators designated by him, do not pose a risk to the subjects and do not interfere with the objectives of the study. Treatment with single doses of symptomatic medication in the week prior to the study sessions will not be grounds for exclusion if it is assumed that it has been completely eliminated on the day of the experimental session.

• Smokers of more than 15 cigarettes a day.

• Subjects who are uncapable of understanding the nature of the trial and the procedures they are required to follow.

• Subjects with positive serology for hepatitis B, C or HIV.

• Women who are pregnant or breastfeeding, or who use hormonal contraceptives or do not use reliable contraceptive measures during the study (such as abstinence, intrauterine devices, barrier methods or with a vasectomized partner).

• Women with amenorrhea or severe premenstrual syndrome.