OBJECTIVE: To evaluate the transfer of delta-9- tetrahydrocannabinol and its metabolites into human breast milk after maternal inhalation of 0.1 g cannabis containing 23.18% delta-9-tetrahydrocannabinol. METHODS: In this pilot pharmacokinetic study, breast milk samples were collected from mothers who regularly consumed cannabis, were 2–5 months postpartum, and exclusively breastfeeding their infants. Women were anonymously recruited for the study. After discontinuing cannabis for at least 24 hours, they were directed to obtain a baseline breast milk sample, then smoke a preweighed, analyzed, standardized strain of cannabis from one preselected dispensary, and collect breast milk samples at specific time points: 20 minutes and 1, 2, and...

Abstract Purpose: Cannabichromene (CBC) is a phytocannabinoid commonly found in cannabis, yet its acute post-dose pharma- cokinetics (PK) have not been examined in humans. This is a secondary data analysis from a trial investigating Spectrum Yellow oil, an oral cannabis product used for medical purposes that contained 20 mg cannabidiol (CBD), 0.9 mg Δ9- tetrahydrocannabinol (THC), and 1.1 mg CBC, per 1 mL of oil. Methods: Participants (N = 43) were randomized to one of 5 groups: 120 mg CBD, 5.4 mg THC, and 6.6 mg CBC daily; 240 mg CBD, 10.8 mg THC, and 13.2 mg CBC daily; 360 mg CBD, 16.2 mg...

Objective: To determine the safety and tolerability of escalating doses of three cannabis oil formulations, containing predominantly CBD, THC, or CBD and THC (1.5:1) vs. placebo in dogs. Design: Randomized, placebo-controlled, blinded, parallel study. Animals: Twenty healthy Beagle dogs (10 males, 10 females). Methods: Dogs were randomly assigned to one of five treatment groups (n = 4 dogs per group balanced by sex): CBD-predominant oil, THC-predominant oil, CBD/THC-predominant oil (1.5:1), sunflower oil placebo, medium-chain triglyceride oil placebo. Up to 10 escalating doses of the oils were planned for administration via oral gavage, with at least 3 days separating doses. Clinical observations, physical examinations, complete blood counts, clinical chemistry, and...

Abstract Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, decision- making surrounding appropriate dosing of cannabis used for medical purposes is limited. This multiple-dose study evaluated the safety, tolerability, PK and PD of Spectrum Yellow oil [20 mg/mL cannabidiol (CBD)/<1mg/mL ∆9-tetrahydrocannabinol (THC)]. Participants (n=43) were randomized to one of five groups: 120 mg CBD and 5.4 mg THC daily, 240 mg CBD and 10.8 mg THC daily, 360 mg CBD and 16.2 mg THC daily, 480 mg CBD and 21.6 mg THC daily or placebo. Study medication was administered every 12 h for 7 consecutive days. Treatment-emergent adverse events (TEAEs);...

Abstract Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, informed physician and patient decision-making surrounding appropriate dosing of cannabis for medical purposes is limited. This Phase 1, multiple-dose study evaluated the safety, tolerability, PK and PD of Spectrum Red softgels (2.5mg ∆9-tetrahydrocannabinol (THC) and <0.25mg cannabidiol (CBD)). Participants (n = 41) were randomized to one of five groups: 5 mg THC and 0.06 mg CBD daily (Treatment A), 10 mg THC and 0.12 mg CBD daily (Treatment B), 15 mg THC and 0.18 mg CBD daily (Treatment C), 20 mg THC and 0.24 mg CBD daily (Treatment D) or placebo....

Introduction Cannabinoid preparations are available across the globe as regulatory agency-approved medicines, through medical cannabis programs, and as hemp-derived products. Many regions, including most provinces in Canada, have designated cannabis businesses as ‘‘essential’’ services during the coronavirus disease 2019 (COVID-19) pandemic, and sales of cannabis remain strong in an otherwise economically challenging time. In light of the potential increased use of cannabis and a recent surge in research to rapidly identify medications to treat COVID-19, it is critical to delineate possible pharmacokinetic (PK) and pharmacodynamic (PD) drug–drug interactions (DDIs) between cannabinoids and such experimental medications. Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are lipophilic, highly protein...

Abstract Objectives: The aim of this study was to determine the safety and tolerability of escalating doses of orally delivered cannabis oils predominant in cannabidiol (CBD), tetrahydrocannabinol (THC), or both CBD and THC in healthy cats. Methods: In this placebo-controlled, blinded study, 20 healthy adult cats were randomized to one of five treatment groups (n = 4 per group): two placebo groups (sunflower oil [SF] or medium-chain triglyceride oil [MCT]), or three plant-derived cannabinoid oil groups (CBD in MCT, THC in MCT or CBD/THC [1.5:1] in SF). Up to 11 escalating doses of each formulation were delivered orally via syringe to fasted subjects, with...

Abstract Introduction: Despite increasing demand for data, little is known about the authorization patterns, safety, and effectiveness of medical cannabis products. Materials and Methods: We conducted a 2 year observational study of adult patients who were legally authorized a medical cannabis product from a single licensed producer; we captured and analyzed authorized cannabis use patterns by cannabinoid profile (tetrahydrocannabinol [THC]-dominant; cannabidiol [CBD]-dominant; and balanced (THC:CBD) and clinical outcomes using standardized outcome measures every 3 months for 12 months at a network of medical cannabis clinics in Quebec, Canada. Results: We recruited 585 patients (average age 56.5 years), of whom 61% identified as female and...

Abstract Introduction: Legalization of medicinal cannabis around the world has led to an increase in the use of commercial cannabis-based products in the community. These cannabis-based products are being used in combination with conventional drugs to treat a variety of health conditions. Moreover, recreational cannabis-based products may be used in combination with other drugs. In this setting, there is increased potential for drug–drug inter- actions (DDIs) involving commercial cannabis-based products. Since DDIs can lead to serious adverse events, drug regulatory bodies require that every investigational drug be evaluated for DDI potential at metabolic enzymes and transporters. However, this seldom occurs for cannabis-based products due...

Abstract Introduction: Clinical trials remain the gold standard for evaluating efficacy, but there is increasing interest in using real-world evidence (RWE) to inform health care decision making. The aims of this observational study were to describe patterns of medical cannabis use, associated changes in symptom severity over time, and to evaluate change in cannabis dose over time for pain-related symptoms. Methods: Data were collected by Strainprint, an application that is HIPAA, PIPEDA, and PHIPA compliant. A total of 629 participants recorded data between May 2017 and August 2019. A total of 65 symptoms were grouped as Pain, Mental Health, Physical Symptoms, Seizures, Headaches/Migraines, and...