Medical Cannabis and Cannabinoids最新文献

Introduction: Dronabinol is approved in the USA for chemotherapy-induced nausea as well as vomiting and HIV-induced anorexia, while cannabidiol is primarily approved for childhood epileptic disorders Lennox-Gastaut and Dravet syndrome. The use pattern for these prescription cannabinoids in the USA is unknown. This study examined Medicaid claims for two FDA-approved prescription cannabinoids, dronabinol and cannabidiol, approved in 1985 and 2018, respectively, from 2016-2020 to better understand the pharmacoepidemiologic trends and distribution of these drugs in US Medicaid amidst the increasing use of non-pharmaceutical formulations of cannabis.

Methods: The longitudinal study analyzed Medicaid prescription claims that were calculated by extracting the prescriptions on a state level from 2016 to 2020 for two cannabinoids, dronabinol and cannabidiol, where outcomes over each year were calculated. Outcomes were (1) the number of prescriptions for each state corrected for the number of Medicaid enrollees and (2) dronabinol and cannabidiol spending. Spending refers to the amount reimbursed by the state Medicaid program.

Results: Dronabinol prescriptions per state decreased by 25.3% from 2016 to 2020, while cannabidiol prescriptions increased by 16,272.99% from 2018 to 2020. The spending on these drugs parallels that of their prescription trend with a 66.3% decrease in reimbursement for dronabinol ($5.7 million in 2020), whereas cannabidiol increased by +26,582.0% ($233.3 million in 2020). Dronabinol prescriptions, when corrected for the number of enrollees, in Connecticut were 136.4 times larger than in New Mexico, and seventeen states had zero prescriptions. Idaho's prescriptions of cannabidiol (27.8/10,000 enrollees) were significantly elevated relative to the national average and were 15.4-fold higher than Washington, DC (1.8/10K enrollees).

Conclusions: The prescriptions of pharmaceutical-grade tetrahydrocannabinol decreased while those of cannabidiol increased. This study also identified pronounced state-level variation in cannabinoid prescribing to Medicaid patients. State formularies and prescription drug list variation may contribute to the drug reimbursements in Medicaid, though further research is needed to identify the health policy or pharmacoeconomic origins of these disparities.

Introduction: Previous research indicated that cannabidiol (CBD) may result in low levels of male total testosterone (TT), elevations in liver tests (LTs), and daytime drowsiness (DD). We investigated the prevalences of TT and LT in a large adult sample self-administering CBD and determined the effect self-dosing of CBD has on the severity of DD.

Methods: Adult participants (18-75 years of age) who self-dose CBD orally for a minimum of 30 days were recruited for this decentralized observational study from companies that offer CBD products. Participants were sent their usual CBD regimen. A clinical study platform was used on a phone app to obtain consent and collect study data. Data included demographic information, reasons for self-dosing, dosage, current medications and dosage, medical history, adverse effects, effects on DD, and efficacy. After 30 days, LT and TT were obtained and follow-up LT was offered to participants who demonstrated elevated values of alanine transaminase (ALT).

Results: A total of 28,121 individuals were contacted, 1,475 met the criteria and were enrolled, and 1,061 (female: 65.2%, male: 34.8%) completed the study. Most of the participants used full-spectrum CBD oil or CBD isolate with the mean ± SD daily dose of CBD for all users of 55.4 ± 37.8 mg. CBD use was associated with a significant decrease in DD and a decrease in the prevalence of low TT in males >40 years of age. The prevalences of elevations in ALT and aspartate aminotransferase were not significantly different from those of the general adult population, and the prevalences of elevated levels of alkaline phosphatase and bilirubin were less than those of a healthy adult population. There was no relationship between LT and CBD dose.

Conclusions: In this large-sample study, self-dosing CBD was not associated with an increased prevalence of elevation of LT or low levels of TT in men. Furthermore, CBD administration decreased DD and was associated with a lower prevalence of low testosterone levels in older men as compared to age-adjusted population norms.

Non-prescription cannabidiol (CBD) and medical marijuana (cannabis) currently do not have US Food and Drug Administration (FDA)-approved prescribing information nor a dedicated resource to evaluate potential cannabinoid drug-drug interactions with other medications. The CANNabinoid Drug Interaction Review (CANN-DIR™) is a free web-based platform that has been developed to screen for potential drug-drug interactions from the perspective of how a cannabinoid delta-9-tetrahydrocannabinol (THC), CBD, or a combination of THC/CBD may affect the metabolism of another prescribed medication. CANN-DIR™ is based on FDA-approved prescribing information for the prescription cannabinoids (dronabinol, nabilone, nabiximols, and prescription CBD) and other FDA-approved prescribing information for medications sharing similar metabolic enzymes (e.g., the FDA "Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers"). The Summary of Product Characteristics (SmPC) was the source of drug-drug interaction information for the combined ∆⁹-THC & CBD product nabiximols (Sativex^®). CANN-DIR™ provides an expeditious review of cannabinoid drug-drug interaction information, and also a platform from which the patient and health care provider can print out the search results to either initiate a conversation, or for the health care provider to provide a written information sheet to supplement their verbal discussion. Additionally, to more effectively reach a global audience, the end user of CANN-DIR™ has the ability to currently navigate and print results in any of the following ten languages: Chinese, English, French, German, Nepali, Polish, Russian, Spanish, Swedish, and Vietnamese.

Introduction: Anal fissure (AF) is a common anorectal disease. Although several pharmacological treatments are available, many patients still require surgical interventions. In this study, we aimed to evaluate the efficacy of an ointment based on a multifunctional blend of herbal ingredients including hemp (ProctoFiz) for chronic AF.

Methods: A single-arm, questionnaire-based prospective study was conducted in a large tertiary center to evaluate the outcomes of patients suffering from chronic AF treated with topical ProctoFiz.

Results: Ninety-two patients were included in the study, 54 (58.7%) were females with a median age of 39 (range 17-78). 32 patients (34.7%) suffered from recurrent AF before enrolling in the study, and 5 patients (5.4%) underwent previous surgical interventions for AF. Three patients (3.2%) were lost to follow-up, leaving 89 patients for analysis. Eighty patients (89.9%) reported significant improvement of symptoms after 1 week using ProctoFiz, and 79 patients reported continued improvement after 1 month of treatment. The mean pain Visual Analog Score (VAS) declined by 6.6 points (8.9 vs. 2.3; 95% CI: 7.20 to -5.99, p < 0.0001) following 1 week of treatment, with continuous improvement to a mean of 0.64 after 1 month. Negative impact on quality of life significantly decreased from a mean of 8.8 to 0.38 following a month of treatment (p < 0.0001), with significant reduction in the number of patients suffering from bleeding following bowel movements (64.1-2.5%; p = 0.0001).

Conclusion: Hemp-based topical treatment of AF is feasible and significantly improves AF-correlated symptoms.

Multilocular pain syndromes with advanced chronification lead to a significant reduction in the quality of life of patients. The administration of cannabis is currently being discussed in the context of therapy-resistant pain and increasing opiate abuse. In this case study, possible side effects from the administration of a cannabis extract tetrahydrocannabinol:cannabidiol are examined. Furthermore, the effect on pain intensity and sleep quality is recorded. Due to numerous comorbidities in the patient, interactions with other medications are documented.

This work is a literature review, presenting the current state of the use of cannabinoids on neurodegenerative diseases. The emphasis is on Parkinson's (PD) and Alzheimer's (AD) diseases, the two most prevalent neurological diseases. The review goes from Cannabis sativa and its hundreds of bioactive compounds to Δ⁹-tetrahydrocannabinol (THC) and mainly cannabidiol (CBD) and their interactions with the endocannabinoid receptors (CB1 and CB2). CBD molecular targets were also focused on to explain its neuroprotective action mechanism on neurodegenerative diseases. Although THC is the main psychoactive component of C. sativa, and it may induce transient psychosis-like symptoms, growing evidence suggests that CBD may have protective effects against the psychotomimetic effects of THC and therapeutic properties. Furthermore, a great number of recent works on the neuroprotective and anti-inflammatory CBD effects and its molecular targets are also reviewed. We analyzed CBD actions in preclinical and in clinical trials, conducted with PD and AD patients. Although the data on preclinical assays are more convincing, the same is not true with the clinical data. Despite the consensus among researchers on the potential of CBD as a neuroprotective agent, larger and well-designed randomized clinical trials will be necessary to gather conclusive results concerning the use of CBD as a therapeutic strategy for the treatment of diseases such as PD and AD.

Introduction: Cannabidiol (CBD) is a widely utilized nonpsychoactive cannabinoid available as an over-the-counter supplement, a component of medical cannabis, and a prescriptive treatment of childhood epilepsies. In vitro studies suggest CBD may inhibit a number of drug-metabolizing enzymes, including carboxylesterase 1 (CES1). The aim of this study was to evaluate effect of CBD on the disposition of the CES1 substrate methylphenidate (MPH).

Methods: In a randomized, placebo-controlled, crossover study, 12 subjects ingested 750 mg of CBD solution, or alternatively, a placebo solution twice daily for a 3-day run-in period followed by an additional CBD dose (or placebo) and a single 10 mg dose of MPH and completed serial blood sampling for pharmacokinetic analysis. MPH and CBD concentrations were measured by liquid chromatography with tandem mass spectrometry.

Results: The C_max (mean ± CV) for the CBD group and placebo group was 13.5 ± 43.7% ng/mL and 12.2 ± 36.4% ng/mL, respectively. AUC_inf (ng/mL*h) for the CBD group and placebo group was 70.7 ± 32.5% and 63.6 ± 25.4%, respectively. The CBD AUC_0-8h (mean ± CV) was 1,542.2 ± 32% ng/mL*h, and C_max was 389.2 ± 39% ng/mL. When compared to MPH only, the geometric mean ratio (CBD/control, 90% CI) for AUC_inf and C_max with CBD co-administration was 1.09 (0.89, 1.32) and 1.08 (0.85, 1.37), respectively.

Discussion/conclusion: Although the upper bound of bioequivalence was not met, the mean estimates of AUC and C_max ratios were generally small and unlikely to be of clinical significance.