Cannabis UsePhase 1CANNMEDNCT04841993
Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation
A Phase 1 study testing Cannabis decoction, Cannabis oil and Vaporized cannabis in people with Cannabis Use and Healthy Subjects, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Healthy Subjects
- What is being tested?
- Cannabis decoction, Cannabis oil and Vaporized cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 10 Dec 2018to 28 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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…).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation in Healthy Adult Recreational Cannabis Users
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
Read the 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
- Conditions
- Cannabis Use, Healthy Subjects
- Being tested
- Cannabis decoction, Cannabis oil, Vaporized cannabis
- Keywords
- medical cannabis, pharmacokinetics, acute effects, cannabis decoction, cannabis oil, vaporized cannabis, oral cannabis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis decoctionDrug
Also called Cannabis tea
A single 100 mL dose of cannabis decoction is administered containing 1.8 mg THC and 2.7 mg CBD.
Cannabis oilDrug
A single administration of 15 drops (045 mL) of cannabis oil containing 1.8 mg THC and 3.8 mg CBD.
Vaporized cannabisDrug
Also called Inhaled cannabis
100mg of vaporized cannabis is administered by Volcano vaporizer, wich containing 0.6-2 mg THC and 0.8-3 mg CBD
| Study group | Role | What they receive |
|---|---|---|
| Oral formulation: Cannabis decoction | Experimental | 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. Receives: Drug: Cannabis decoction |
| Oral formulation: Cannabis oil | Experimental | 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. Receives: Drug: Cannabis oil |
| Vaporized formulation: Cannabis vaporized | Experimental | 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 . Receives: Drug: Vaporized cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
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.
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
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.
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
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.
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Time to reach maximum serum concentration (Tmax) of THC
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Time to reach maximum serum concentration (Tmax) of THCA
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Time to reach maximum serum concentration (Tmax) of THC metabolites
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Time to reach maximum serum concentration (Tmax) of CBD
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Time to reach maximum serum concentration (Tmax) of CBDA
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
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.
Measured: From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
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.
Measured: From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
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.
Measured: From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
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.
Measured: From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
Secondary outcomes (23)
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
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Time to reach maximum oral fluid concentration (Tmax) of THC
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Time to reach maximum oral fluid concentration (Tmax) of THCA
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Time to reach maximum oral fluid concentration (Tmax) of CBD
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Time to reach maximum oral fluid concentration (Tmax) of CBDA
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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.
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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
Measured: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
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.
.
Measured: Differences from baseline to 24 hours
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).
Measured: Differences from baseline to 24 hours
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).
Measured: Differences from baseline to 24 hours
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.
Measured: Differences from baseline to 24 hours
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.
Measured: Differences from baseline to 24 hours
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.
Measured: Differences from baseline to 24 hours
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.
Measured: Differences from baseline to 24 hours
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.
Measured: Differences from baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start10 Dec 2018
- Primary completion18 Dec 2019
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol, Istituto Superiore di Sanità
- Responsible party
- Sponsor
- Investigators
- Magi Farré, MD, PhD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841993
- Sponsor's protocol ID
- HUGTP/CANNMED/1
- Acronym
- CANNMED
- Status last verified
- Apr 2021
- First submitted
- 3 Mar 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33451073Perez-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.
PubMed 33322849Pichini 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.
PubMed 33298281Perez-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.
PubMed 33155722
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation in Healthy Adult Recreational Cannabis Users
- ClinicalTrials.gov ID
- NCT04841993
- Acronym / sponsor ID
- CANNMED / HUGTP/CANNMED/1
- Conditions
- Cannabis Use, Healthy Subjects
- Keywords
- medical cannabis, pharmacokinetics, acute effects, cannabis decoction, cannabis oil, vaporized cannabis, oral cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol, Istituto Superiore di Sanità
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral formulation: Cannabis decoction | Experimental | Drug: Cannabis decoctionFrom 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. |
| Oral formulation: Cannabis oil | Experimental | Drug: Cannabis oilFrom 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. |
| Vaporized formulation: Cannabis vaporized | Experimental | Drug: Vaporized cannabisFrom 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 . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis decoctionAlso: Cannabis teaA single 100 mL dose of cannabis decoction is administered containing 1.8 mg THC and 2.7 mg CBD. | Drug | Oral formulation: Cannabis decoction |
| Cannabis oilA single administration of 15 drops (045 mL) of cannabis oil containing 1.8 mg THC and 3.8 mg CBD. | Drug | Oral formulation: Cannabis oil |
| Vaporized cannabisAlso: Inhaled cannabis100mg of vaporized cannabis is administered by Volcano vaporizer, wich containing 0.6-2 mg THC and 0.8-3 mg CBD | Drug | Vaporized formulation: Cannabis vaporized |
Primary outcome
Maximum serum concentration (Cmax) of THC
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
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
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
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
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
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
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
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 frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time to reach maximum serum concentration (Tmax) of THCA
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time to reach maximum serum concentration (Tmax) of THC metabolites
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time to reach maximum serum concentration (Tmax) of CBD
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations.
Time to reach maximum serum concentration (Tmax) of CBDA
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.
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
Time frame: From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
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
Time frame: From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
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
Time frame: From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
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
Time frame: From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis )
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.
23 secondary outcomes
Maximum oral fluid concentration (Cmax) of THC
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Maximum oral fluid concentration (Cmax) of THCA
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Maximum oral fluid concentration (Cmax) of CBD
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Maximum oral fluid concentration (Cmax) of CBDA
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Time to reach maximum oral fluid concentration (Tmax) of THC
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Time to reach maximum oral fluid concentration (Tmax) of THCA
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Time to reach maximum oral fluid concentration (Tmax) of CBD
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Time to reach maximum oral fluid concentration (Tmax) of CBDA
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Area under the concentration-time curve (AUC 0-24h) of THC oral fluid concentrations
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Area under the concentration-time curve (AUC 0-24h) of THCA oral fluid concentrations
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Area under the concentration-time curve (AUC 0-24h) of CBD oral fluid concentrations
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Area under the concentration-time curve (AUC 0-24h) of CBDA oral fluid concentrations
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Total amount cannabis metabolites (THC-carboxy and THC-glucoronides, excreted in 24 h urine samples.
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Total concentration of THC present in sweat after oral and vaporized cannabis administration.
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Total concentration of CBD present in sweat after oral and vaporized cannabis administration.
Time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration
Change in blood pressure: Emax (peak/maximum effects) in blood pressure
Time frame: Differences from baseline to 24 hours
Change in Heart rate: Emax (peak/maximum effects) in Heart rate
Time frame: Differences from baseline to 24 hours
Change in oral temperature: Emax (peak/maximum effects) in oral temperature
Time frame: Differences from baseline to 24 hours
Change in Intensity of effects: Emax (peak/maximum effects) in Intensity of effects
Time frame: Differences from baseline to 24 hours
Change in High feeling: Emax (peak/maximum effects) in High feeling
Time frame: Differences from baseline to 24 hours
Change in Hunger: Emax (peak/maximum effects) in Hunger
Time frame: Differences from baseline to 24 hours
Change in Drowsines: Emax (peak/maximum effects) in Drowsiness
Time frame: Differences from baseline to 24 hours
Change in global drug effects: Emax (peak/maximum effects) in global drug effects
Time frame: Differences from baseline to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Results publication: PubMed 33451073Busardo 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 publication: PubMed 33322849Perez-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 publication: PubMed 33298281Pichini 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 publication: PubMed 33155722Perez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magi Farré, MD, PhD principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis decoction, Cannabis oil and Vaporized cannabis in people with Cannabis Use and Healthy Subjects, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum serum concentration (Cmax) of THC (time frame: From baseline to 24 hours after decoction, oil or vaporized cannabis administration.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841993, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.