PK/PD du vapotage de liquides contenant du THC par rapport au cannabis fumé
Une étude croisée randomisée au sein d'un sujet pour comparer les effets PK/PD à court terme du vapotage de liquides contenant du THC par rapport au cannabis fumé
We will conduct a randomized, within-subjects clinical study to compare short-term pharmacokinetic (PK) and pharmacodynamic (PD) effects of Δ9-tetrahydrocannabinol (THC) vaping liquids vs. smoked cannabis containing 6 equivalent standard THC units (5 mg THC=1 Standard THC Unit (STU)) in healthy community members who are current users of both products. While smoking cannabis remains the most common mode of THC use among adults and youth, alternative modes of delivery, such as Electronic Vaping Products (EVPs), are becoming increasingly popular for the delivery of cannabinoids. Declining cannabis risk perceptions, increasing normalization of cannabis, greater legal access and availability to cannabis, ease of administration, and ability to conceal vaped THC use have likely contributed to increasing prevalence of use throughout the population across all age groups. Comparing vaping THC containing liquids with smoking cannabis can serve as an important benchmark for evaluating the delivery and effects of THC vaping products and, their relative safety
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVE:
I. Compare the PK/PD profiles of delta-9 tetrahydrocannabinol (THC) from equivalent standard THC doses (30mg) administered as vaped THC liquid vs. smoked cannabis using a within-subject design.
SECONDARY OBJECTIVES:
I. Safety
PRIMARY OBJECTIVE:
I. Compare the PK/PD profiles of delta-9 tetrahydrocannabinol (THC) from equivalent standard THC doses (30mg) administered as vaped THC liquid vs. smoked cannabis using a within-subject design.
SECONDARY OBJECTIVES:
I. Safety
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Danielle Smith
- Numéro de téléphone: 8772757724
- E-mail: askroswell@roswellpark.org
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age >= 21 years of age
- Report concurrent use of commercial (medical or recreational) smoked cannabis and THC vaping cartridges for at least 3 months prior to enrollment
- Report smoking cannabis and THC- vaping liquid use at the potency level of the study product at least weekly (4x/month)
- Report of not currently trying to become pregnant (females). Women of childbearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures
- Willing to complete a THC saliva test to check for recent use (NarcoCheck Ref#:NCE-STHC-1) and semi -quantitative urinary tetrahydrocannabinol-carboxylic acid (THCA) rapid test (NarcoCheck® THC PreDosage) during baseline testing, prior to receiving any study-related products
- Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
-
• Illegal or non-prescription drug use within the past 90 days. As detected by NacroCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product
- Report 2 or more drinking occasions/week with 4 or more drinks/occasion
- Report of daily nicotine use
- Current or prior diagnosis of any psychotic disorders
- Current or prior diagnosis of chronic heart conditions
- Current or prior diagnosis of any respiratory condition
- Pregnant or currently trying to become pregnant (females)
- Detection level 4-5 (>300 ng/mL) from a semi-quantitative urinary THCA rapid test (NarcoCheck® THC PreDosage)
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Arm 1 (Vape followed by Joint)
Patients receive a vape device with THC containing liquid and consume the provided amount in up to 10 minutes. 7 to 14 days later patients receive a cannabis joint and smoke the provided joint in up to 10 minutes. Patients also undergo blood sample collection throughout the study. |
Consume THC via vape defice
Autres noms:
Given via joint
Autres noms:
|
|
Expérimental: Arm II (Joint followed by Vape)
Patients receive a cannabis joint and smoke the provided joint in up to 10 minutes. 7 to 14 days later patients receive a vape device with THC containing liquid and consume the provided amount in up to 10 minutes. Patients also undergo blood sample collection throughout the study. |
Consume THC via joint
Autres noms:
Given via vape device
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peak Plasma Concentration (Cmax)
Délai: From baseline to 360 minutes after consuming product
|
Blood samples will be collected for plasma levels of THC. All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex |
From baseline to 360 minutes after consuming product
|
|
Area under the plasma concentration time curve from 0-360 minutes ((AUC^0-360)
Délai: From baseline to 360 minutes after consuming product
|
Blood samples will be collected for plasma levels of THC. All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex. |
From baseline to 360 minutes after consuming product
|
|
Time to maximum concentration of THC in plasma (Tmax)
Délai: From baseline to 360 minutes after consuming product
|
Blood samples will be collected for plasma levels of THC.All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex. |
From baseline to 360 minutes after consuming product
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of adverse events
Délai: Up to 360 minutes after consuming product
|
Number of subjects who experienced an adverse event during the study . |
Up to 360 minutes after consuming product
|
|
Puffing behaviors
Délai: Through study completion, an average of 14 days
|
Measure changes in subject puffing behavior by mean number of puffs and duration |
Through study completion, an average of 14 days
|
|
Short term effects of THC
Délai: Through Study completion, an average of 14 days
|
The Drug Effect Questionnaire (DEQ) rates sixteen component items using a visual analog scale (0-100) to examine drug effects pre- and post-use. |
Through Study completion, an average of 14 days
|
|
Cognitive Performance as assessed by the Digit Symbol Substitution Task (DSST)
Délai: Through study completion, an average of 14 days
|
computerized sensitive and valid assessment of cognitive dysfunction that correlates with real-world functional ability to complete daily tasks. The outcome is the total number of correct responses. |
Through study completion, an average of 14 days
|
|
Paced Auditory Serial Addition Task (PASET)
Délai: Through study completion , an average of 14 days
|
a validated measure used to assess attention, concentration, working memory, and information processing. |
Through study completion , an average of 14 days
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Danielle Smith, Roswell Park Comprehensive Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- I 3409223
- R01DA057228 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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