Back to resultsPharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation (CANNMED)
Primary Purpose
Cannabis Use, Healthy Subjects
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Cannabis decoction
Cannabis oil
Vaporized cannabis
Sponsored by
About this trial
This is an interventional basic science trial for Cannabis Use focused on measuring medical cannabis, pharmacokinetics, acute effects, cannabis decoction, cannabis oil, vaporized cannabis, oral cannabis
Eligibility 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.
Sites / Locations
- Germans Trias i Pujol Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Oral formulation: Cannabis decoction
Oral formulation: Cannabis oil
Vaporized formulation: Cannabis vaporized
Arm Description
From a standardized preparation cannabis Cannabis FM2 (THC) (~ 6%) and (CBD) (~ 8%) ,cannabis decoction will be prepared at the moment by putting female inflorescences in cold water brought to a boil, boiling for 15 minutes and using 500 mg of medicinal cannabis for 500 ml of water.
From a standardized preparation cannabis Cannabis FM2 (THC) (~ 6%) and (CBD) (~ 8%), cannabis oil is prepared the day before the experimental session with 500 mg of female inflorescences in 5 ml of olive oil from the European Pharmacopoeia, heating in a water bath (approximately 98 ° C) for 120 minutes and cooling the oil samples. at room temperature.
From a standardized preparation cannabis Cannabis FM2 (THC) (~ 6%) and (CBD) (~ 8%), 100 mg of Cannabis inflorescences of FM2 standardized cannabis were administered through Volcano vaporizer .
Outcomes
Primary Outcome Measures
Maximum serum concentration (Cmax) of THC
Calculation of maximum concentration (ng/mL) in samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Maximum serum concentration (Cmax) of THCA
Calculation of maximum concentration (ng/mL) in samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Maximum serum concentration (Cmax) of CBD
Calculation of maximum concentration (ng/mL) in samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Maximum serum concentration (Cmax) of CBDA
Calculation of maximum concentration (ng/mL) in samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Time to reach maximum serum concentration (Tmax) of THC
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time to reach maximum serum concentration (Tmax) of THCA
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time to reach maximum serum concentration (Tmax) of THC metabolites
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time to reach maximum serum concentration (Tmax) of CBD
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time to reach maximum serum concentration (Tmax) of CBDA
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Area under the concentration-time curve (AUC 0-24 h) of THC in serum concentrations
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Area under the concentration-time curve (AUC 0-24 h) of THCA in serum concentrations
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Area under the concentration-time curve (AUC 0-24 h) of CBD in serum concentrations
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Area under the concentration-time curve (AUC 0-24 h) of CBDA in serum concentrations
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Secondary Outcome Measures
Maximum oral fluid concentration (Cmax) of THC
Calculation of maximum concentration (ng/mL) oral fluid samples collected with a Salivette device at the same time points as serum. Ora liquid is collected 15 min before administration (time zero), at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after the oral formulation of cannabis (decoction or oil) and in the case of vaporized cannabis at 15 minutes before zero time (administration), at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours
Maximum oral fluid concentration (Cmax) of THCA
Calculation of maximum concentration (ng/mL) oral fluid samples collected with a Salivette device at the same time points as serum. Ora liquid is collected 15 min before administration (time zero), at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after the oral formulation of cannabis (decoction or oil) and in the case of vaporized cannabis at 15 minutes before zero time (administration), at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours
Maximum oral fluid concentration (Cmax) of CBD
Calculation of maximum concentration (ng/mL) oral fluid samples collected with a Salivette device at the same time points as serum. Ora liquid is collected 15 min before administration (time zero), at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after the oral formulation of cannabis (decoction or oil) and in the case of vaporized cannabis at 15 minutes before zero time (administration), at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours
Maximum oral fluid concentration (Cmax) of CBDA
Calculation of maximum concentration (ng/mL) oral fluid samples collected with a Salivette device at the same time points as serum. Ora liquid is collected 15 min before administration (time zero), at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after the oral formulation of cannabis (decoction or oil) and in the case of vaporized cannabis at 15 minutes before zero time (administration), at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours
Time to reach maximum oral fluid concentration (Tmax) of THC
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Time to reach maximum oral fluid concentration (Tmax) of THCA
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Time to reach maximum oral fluid concentration (Tmax) of CBD
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Time to reach maximum oral fluid concentration (Tmax) of CBDA
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Area under the concentration-time curve (AUC 0-24h) of THC oral fluid concentrations
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 hours
Area under the concentration-time curve (AUC 0-24h) of THCA oral fluid concentrations
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 hours
Area under the concentration-time curve (AUC 0-24h) of CBD oral fluid concentrations
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 hours
Area under the concentration-time curve (AUC 0-24h) of CBDA oral fluid concentrations
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 hours
Total amount cannabis metabolites (THC-carboxy and THC-glucoronides, excreted in 24 h urine samples.
Urine was collected 15 minutes before administration (time zero) and then between 0-2 h, 2-4 h, 6 h-8 h, 8-10 h, and 10-24 h after administration of oral and vaporized formulations.
Total concentration of THC present in sweat after oral and vaporized cannabis administration.
Concentration in ng/patch. Samples were collected with dermal patches (5 x 5 cm areas) applied to the back and removed at different intervals such as: 0-2 h, 2-4 h, 4-6 h, 6-8 h, 8-10 h, 10-12 h and 12-24 h
Total concentration of CBD present in sweat after oral and vaporized cannabis administration.
Concentration in ng/patch. Samples were collected with dermal patches (5 x 5 cm areas) applied to the back and removed at different intervals such as: 0-2 h, 2-4 h, 4-6 h, 6-8 h, 8-10 h, 10-12 h and 12-24 h
Change in blood pressure: Emax (peak/maximum effects) in blood pressure
Non-invasive systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) were repeatedly recorded at baseline (45 and 15 min) prior to decoction or oil administration, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration. In case o vaporized cannabis were recorded at baseline (45 and 15 min) before and 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after administration.
Blood pressure measured in mmHg.
.
Change in Heart rate: Emax (peak/maximum effects) in Heart rate
Heart rate were repeatedly recorded at baseline (45 and 15 min) prior to decoction or oil administration, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration. In case of vaporized cannabis were recorded at baseline (45 and 15 min) before and 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after administration .
Heart rate measured in beats per minute (bpm).
Change in oral temperature: Emax (peak/maximum effects) in oral temperature
Oral temperature were repeatedly recorded at baseline (45 and 15 min) prior to decoction or oil administration, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration. In case o vaporized cannabis were recorded at baseline (45 and 15 min) before and 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after administration .
Oral temperature measured in Celsius degrees (ºC).
Change in Intensity of effects: Emax (peak/maximum effects) in Intensity of effects
Intensity of effects will be measured using a visual analog scale (0-100 mm) at baseline and 0.30, 1, 1.30, 2, 3, 4, 6,8, 10 and 24 h after oral cannabis administration, and at baseline ,10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after vaporized cannabis administration.
Higher mm means more intensity of effects.
Change in High feeling: Emax (peak/maximum effects) in High feeling
High will be measured using a visual analog scale 0-100 mm) at baseline and 0.30, 1, 1.30, 2, 3, 4, 6,8, 10 and 24 h after oral cannabis administration , and at baseline ,10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after vaporized cannabis administration.
Higher mm means more high feeling.
Change in Hunger: Emax (peak/maximum effects) in Hunger
Hunger will be measured using a visual analog scale (0-100 mm) at baseline and 0.30, 1, 1.30, 2, 3, 4, 6,8, 10 and 24 h after oral cannabis administration , and at baseline ,10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after vaporized cannabis administration.
Higher mm means more hunger.
Change in Drowsines: Emax (peak/maximum effects) in Drowsiness
Drowsiness will be measured using a visual analog scale (0-100 mm) at baseline and 0.30, 1, 1.30, 2, 3, 4, 6,8, 10 and 24 h after oral cannabis administration , and at baseline ,10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after vaporized cannabis administration.
Higher mm means more drowsiness.
Change in global drug effects: Emax (peak/maximum effects) in global drug effects
Global drug effects will be measured using the short form (49 items) of the Addiction Research Center Inventory (ARCI) . This is a true/false response questionnaire with 49 items. The global results include five subscales (sedation, euphoria, dysphoria, intellectual efficiency and amphetamine-like effects.
It is administered at baseline and 0.30, 1, 1.30, 2, 3, 4, 6,8, 10 and 24 h after oral cannabis administration , and at baseline, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after vaporized cannabis administration.
Scores range usually from a total of 12 to 57 points. More points mean more effects.
Full Information
NCT ID
NCT04841993
First Posted
March 3, 2021
Last Updated
April 9, 2021
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundació Institut Germans Trias i Pujol, Istituto Superiore di Sanità
1. Study Identification
Unique Protocol Identification Number
NCT04841993
Brief Title
Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation
Acronym
CANNMED
Official Title
Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation in Healthy Adult Recreational Cannabis Users
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundació Institut Germans Trias i Pujol, Istituto Superiore di Sanità
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed Description
Medical cannabis" encompasses the use of cannabis and cannabinoids for therapeutic purposes. Includes drugs approved by regulatory agencies and pharmaceutical products. Recently, many countries have authorized the use of cannabis flower cups with a standardized amount of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) and their acidic precursors (Δ-9-tetrahydrocannabinolic acid A [THCA] and cannabidiol acid [ CBDA]) for the treatment of different diseases. In Italy since January 2017 there has been for sale a standardized cannabis preparation produced by the Military Pharmaceutical Institute of Florence. This medicinal variety of cannabis sativa, known as FM2 has a variable THC and CBD percentage of between 5-8% and 7-12% respectively. To date, there are no studies on the pharmacokinetics of THC, CBD and other minor cannabinoids in conventional and unconventional biological matrices after oral administration of cannabis tea, cannabis oil and vaporized with the same medicinal preparation (FM2). The main objective is to know the concentrations of THC, CBD and metabolites, and other cannabinoids in blood, urine, oral fluid and sweat after the experimental administration of a standardized cannabis preparation orally (two formulations: cannabis tea and cannabis oil) and vaporized. In addition, the acute pharmacological effects and tolerability will be evaluated. Healthy recreational cannabis users with experience in oral use of cannabis will participate
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Healthy Subjects
Keywords
medical cannabis, pharmacokinetics, acute effects, cannabis decoction, cannabis oil, vaporized cannabis, oral cannabis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The study was unicentric, open-label, not randomized, not placebo controlled ,single blind. The study included three substudies (one for each formulation administration). The first one for decoction administration, the second one for oil administration, and finally, an experimental session was held for the administration of the standardized vaporized cannabis preparation. Each subject will participate in one experimental session. One treatment condition per subject (of two possible oral formulations and one inhaled / vaporized formulation of vaporized cannabis. Once the experimental session is over, the subjects have the possibility of being able to participate in the same study after a minimum washout period of 3 weeks.
Masking
Participant
Masking Description
Participant were aware of the cannabis preparation but not of the administered doses
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral formulation: Cannabis decoction
Arm Type
Experimental
Arm Description
From a standardized preparation cannabis Cannabis FM2 (THC) (~ 6%) and (CBD) (~ 8%) ,cannabis decoction will be prepared at the moment by putting female inflorescences in cold water brought to a boil, boiling for 15 minutes and using 500 mg of medicinal cannabis for 500 ml of water.
Arm Title
Oral formulation: Cannabis oil
Arm Type
Experimental
Arm Description
From a standardized preparation cannabis Cannabis FM2 (THC) (~ 6%) and (CBD) (~ 8%), cannabis oil is prepared the day before the experimental session with 500 mg of female inflorescences in 5 ml of olive oil from the European Pharmacopoeia, heating in a water bath (approximately 98 ° C) for 120 minutes and cooling the oil samples. at room temperature.
Arm Title
Vaporized formulation: Cannabis vaporized
Arm Type
Experimental
Arm Description
From a standardized preparation cannabis Cannabis FM2 (THC) (~ 6%) and (CBD) (~ 8%), 100 mg of Cannabis inflorescences of FM2 standardized cannabis were administered through Volcano vaporizer .
Intervention Type
Drug
Intervention Name(s)
Cannabis decoction
Other Intervention Name(s)
Cannabis tea
Intervention Description
A single 100 mL dose of cannabis decoction is administered containing 1.8 mg THC and 2.7 mg CBD.
Intervention Type
Drug
Intervention Name(s)
Cannabis oil
Intervention Description
A single administration of 15 drops (045 mL) of cannabis oil containing 1.8 mg THC and 3.8 mg CBD.
Intervention Type
Drug
Intervention Name(s)
Vaporized cannabis
Other Intervention Name(s)
Inhaled cannabis
Intervention Description
100mg of vaporized cannabis is administered by Volcano vaporizer, wich containing 0.6-2 mg THC and 0.8-3 mg CBD
Primary Outcome Measure Information:
Title
Maximum serum concentration (Cmax) of THC
Description
Calculation of maximum concentration (ng/mL) in samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Title
Maximum serum concentration (Cmax) of THCA
Description
Calculation of maximum concentration (ng/mL) in samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Title
Maximum serum concentration (Cmax) of CBD
Description
Calculation of maximum concentration (ng/mL) in samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Title
Maximum serum concentration (Cmax) of CBDA
Description
Calculation of maximum concentration (ng/mL) in samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Title
Time to reach maximum serum concentration (Tmax) of THC
Description
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Title
Time to reach maximum serum concentration (Tmax) of THCA
Description
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Title
Time to reach maximum serum concentration (Tmax) of THC metabolites
Description
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Title
Time to reach maximum serum concentration (Tmax) of CBD
Description
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Title
Time to reach maximum serum concentration (Tmax) of CBDA
Description
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Title
Area under the concentration-time curve (AUC 0-24 h) of THC in serum concentrations
Description
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Time Frame
From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
Title
Area under the concentration-time curve (AUC 0-24 h) of THCA in serum concentrations
Description
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Time Frame
From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
Title
Area under the concentration-time curve (AUC 0-24 h) of CBD in serum concentrations
Description
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Time Frame
From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
Title
Area under the concentration-time curve (AUC 0-24 h) of CBDA in serum concentrations
Description
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours.
Time Frame
From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
Secondary Outcome Measure Information:
Title
Maximum oral fluid concentration (Cmax) of THC
Description
Calculation of maximum concentration (ng/mL) oral fluid samples collected with a Salivette device at the same time points as serum. Ora liquid is collected 15 min before administration (time zero), at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after the oral formulation of cannabis (decoction or oil) and in the case of vaporized cannabis at 15 minutes before zero time (administration), at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Maximum oral fluid concentration (Cmax) of THCA
Description
Calculation of maximum concentration (ng/mL) oral fluid samples collected with a Salivette device at the same time points as serum. Ora liquid is collected 15 min before administration (time zero), at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after the oral formulation of cannabis (decoction or oil) and in the case of vaporized cannabis at 15 minutes before zero time (administration), at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Maximum oral fluid concentration (Cmax) of CBD
Description
Calculation of maximum concentration (ng/mL) oral fluid samples collected with a Salivette device at the same time points as serum. Ora liquid is collected 15 min before administration (time zero), at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after the oral formulation of cannabis (decoction or oil) and in the case of vaporized cannabis at 15 minutes before zero time (administration), at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Maximum oral fluid concentration (Cmax) of CBDA
Description
Calculation of maximum concentration (ng/mL) oral fluid samples collected with a Salivette device at the same time points as serum. Ora liquid is collected 15 min before administration (time zero), at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after the oral formulation of cannabis (decoction or oil) and in the case of vaporized cannabis at 15 minutes before zero time (administration), at 10, 20, 40, 1, 1.5,2,3,4,6,8 and 24 hours
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Time to reach maximum oral fluid concentration (Tmax) of THC
Description
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Time to reach maximum oral fluid concentration (Tmax) of THCA
Description
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Time to reach maximum oral fluid concentration (Tmax) of CBD
Description
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Time to reach maximum oral fluid concentration (Tmax) of CBDA
Description
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Area under the concentration-time curve (AUC 0-24h) of THC oral fluid concentrations
Description
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 hours
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Area under the concentration-time curve (AUC 0-24h) of THCA oral fluid concentrations
Description
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 hours
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Area under the concentration-time curve (AUC 0-24h) of CBD oral fluid concentrations
Description
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 hours
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Area under the concentration-time curve (AUC 0-24h) of CBDA oral fluid concentrations
Description
Calculation of AUC with samples collected from 15 min prior to administration (time zero) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after oral cannabis formulation ( decoction or oil). In the case of vaporized cannabis, serum samples are collected 15 minutes before, at time zero (administration), and at 10, 20, 40, 1, 1.5,2,3,4,6,8 hours
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Total amount cannabis metabolites (THC-carboxy and THC-glucoronides, excreted in 24 h urine samples.
Description
Urine was collected 15 minutes before administration (time zero) and then between 0-2 h, 2-4 h, 6 h-8 h, 8-10 h, and 10-24 h after administration of oral and vaporized formulations.
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Total concentration of THC present in sweat after oral and vaporized cannabis administration.
Description
Concentration in ng/patch. Samples were collected with dermal patches (5 x 5 cm areas) applied to the back and removed at different intervals such as: 0-2 h, 2-4 h, 4-6 h, 6-8 h, 8-10 h, 10-12 h and 12-24 h
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Total concentration of CBD present in sweat after oral and vaporized cannabis administration.
Description
Concentration in ng/patch. Samples were collected with dermal patches (5 x 5 cm areas) applied to the back and removed at different intervals such as: 0-2 h, 2-4 h, 4-6 h, 6-8 h, 8-10 h, 10-12 h and 12-24 h
Time Frame
From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Title
Change in blood pressure: Emax (peak/maximum effects) in blood pressure
Description
Non-invasive systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) were repeatedly recorded at baseline (45 and 15 min) prior to decoction or oil administration, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration. In case o vaporized cannabis were recorded at baseline (45 and 15 min) before and 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after administration.
Blood pressure measured in mmHg.
.
Time Frame
Differences from baseline to 24 hours
Title
Change in Heart rate: Emax (peak/maximum effects) in Heart rate
Description
Heart rate were repeatedly recorded at baseline (45 and 15 min) prior to decoction or oil administration, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration. In case of vaporized cannabis were recorded at baseline (45 and 15 min) before and 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after administration .
Heart rate measured in beats per minute (bpm).
Time Frame
Differences from baseline to 24 hours
Title
Change in oral temperature: Emax (peak/maximum effects) in oral temperature
Description
Oral temperature were repeatedly recorded at baseline (45 and 15 min) prior to decoction or oil administration, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration. In case o vaporized cannabis were recorded at baseline (45 and 15 min) before and 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after administration .
Oral temperature measured in Celsius degrees (ºC).
Time Frame
Differences from baseline to 24 hours
Title
Change in Intensity of effects: Emax (peak/maximum effects) in Intensity of effects
Description
Intensity of effects will be measured using a visual analog scale (0-100 mm) at baseline and 0.30, 1, 1.30, 2, 3, 4, 6,8, 10 and 24 h after oral cannabis administration, and at baseline ,10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after vaporized cannabis administration.
Higher mm means more intensity of effects.
Time Frame
Differences from baseline to 24 hours
Title
Change in High feeling: Emax (peak/maximum effects) in High feeling
Description
High will be measured using a visual analog scale 0-100 mm) at baseline and 0.30, 1, 1.30, 2, 3, 4, 6,8, 10 and 24 h after oral cannabis administration , and at baseline ,10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after vaporized cannabis administration.
Higher mm means more high feeling.
Time Frame
Differences from baseline to 24 hours
Title
Change in Hunger: Emax (peak/maximum effects) in Hunger
Description
Hunger will be measured using a visual analog scale (0-100 mm) at baseline and 0.30, 1, 1.30, 2, 3, 4, 6,8, 10 and 24 h after oral cannabis administration , and at baseline ,10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after vaporized cannabis administration.
Higher mm means more hunger.
Time Frame
Differences from baseline to 24 hours
Title
Change in Drowsines: Emax (peak/maximum effects) in Drowsiness
Description
Drowsiness will be measured using a visual analog scale (0-100 mm) at baseline and 0.30, 1, 1.30, 2, 3, 4, 6,8, 10 and 24 h after oral cannabis administration , and at baseline ,10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after vaporized cannabis administration.
Higher mm means more drowsiness.
Time Frame
Differences from baseline to 24 hours
Title
Change in global drug effects: Emax (peak/maximum effects) in global drug effects
Description
Global drug effects will be measured using the short form (49 items) of the Addiction Research Center Inventory (ARCI) . This is a true/false response questionnaire with 49 items. The global results include five subscales (sedation, euphoria, dysphoria, intellectual efficiency and amphetamine-like effects.
It is administered at baseline and 0.30, 1, 1.30, 2, 3, 4, 6,8, 10 and 24 h after oral cannabis administration , and at baseline, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8, and 24 h after vaporized cannabis administration.
Scores range usually from a total of 12 to 57 points. More points mean more effects.
Time Frame
Differences from baseline to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magi Farré, MD, PhD
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germans Trias i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33451073
Citation
Busardo FP, Perez-Acevedo AP, Pacifici R, Mannocchi G, Gottardi M, Papaseit E, Perez-Mana C, Martin S, Poyatos L, Pichini S, Farre M. Disposition of Phytocannabinoids, Their Acidic Precursors and Their Metabolites in Biological Matrices of Healthy Individuals Treated with Vaporized Medical Cannabis. Pharmaceuticals (Basel). 2021 Jan 13;14(1):59. doi: 10.3390/ph14010059.
Results Reference
result
PubMed Identifier
33322849
Citation
Perez-Acevedo AP, Busardo FP, Pacifici R, Mannocchi G, Gottardi M, Poyatos L, Papaseit E, Perez-Mana C, Martin S, Di Trana A, Pichini S, Farre M. Disposition of Cannabidiol Metabolites in Serum and Urine from Healthy Individuals Treated with Pharmaceutical Preparations of Medical Cannabis. Pharmaceuticals (Basel). 2020 Dec 12;13(12):459. doi: 10.3390/ph13120459.
Results Reference
result
PubMed Identifier
33298281
Citation
Pichini S, Malaca S, Gottardi M, Perez-Acevedo AP, Papaseit E, Perez-Mana C, Farre M, Pacifici R, Tagliabracci A, Mannocchi G, Busardo FP. UHPLC-MS/MS analysis of cannabidiol metabolites in serum and urine samples. Application to an individual treated with medical cannabis. Talanta. 2021 Feb 1;223(Pt 2):121772. doi: 10.1016/j.talanta.2020.121772. Epub 2020 Oct 14.
Results Reference
result
PubMed Identifier
33155722
Citation
Perez-Acevedo AP, Pacifici R, Mannocchi G, Gottardi M, Poyatos L, Papaseit E, Perez-Mana C, Martin S, Busardo FP, Pichini S, Farre M. Disposition of cannabinoids and their metabolites in serum, oral fluid, sweat patch and urine from healthy individuals treated with pharmaceutical preparations of medical cannabis. Phytother Res. 2021 Mar;35(3):1646-1657. doi: 10.1002/ptr.6931. Epub 2020 Nov 6.
Results Reference
result
Learn more about this trial
Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation
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