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| Name | Class |
|---|---|
| FundaciĂł Institut Germans Trias i Pujol | OTHER |
| Istituto Superiore di SanitĂ | OTHER |
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The purposes of the study are 1) to know the concentrations of Î9-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
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 Î9-tetrahydrocannabinol (THC), cannabidiol (CBD) and their acidic precursors (Î-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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis decoction | Drug | A single 100 mL dose of cannabis decoction is administered containing 1.8 mg THC and 2.7 mg CBD. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | From baseline to 24 hours after decoction, oil or vaporized cannabis administration. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magi Farré, MD, PhD | Germans Trias i Pujol Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias i Pujol Hospital | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33451073 | Result | 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. | |
| 33322849 |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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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.
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Participant were aware of the cannabis preparation but not of the administered doses
| Cannabis oil | Drug | A single administration of 15 drops (045 mL) of cannabis oil containing 1.8 mg THC and 3.8 mg CBD. |
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| Vaporized cannabis | Drug | 100mg of vaporized cannabis is administered by Volcano vaporizer, wich containing 0.6-2 mg THC and 0.8-3 mg CBD |
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| Time to reach maximum serum concentration (Tmax) of THC | Time to reach maximun concentration after decoction, oil or vaporized cannabis formulations. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From baseline to 24 hours after administration ( decoction, oil or vaporized cannabis ) |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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. . | 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). | 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 (ÂșC). | 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. | 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. | 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. | 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. | 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. | Differences from baseline to 24 hours |
| 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. |
| 33298281 | Result | 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. |
| 33155722 | Result | 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. |