Cannabis sativa L. and Its Extracts: Regulation of Cannabidiol in the European Union and United Kingdom.

The lawful sale of Cannabis sativa L. and its extracts including Cannabidiol is not harmonized under European Union law. Such products have in the most part been classified as novel foods and thus illegal for sale in Europe without prior authorization. The regulation of such substances not only spans EU and Member State food laws but also international conventions on illicit drug and psychoactive substances. An understanding of the laws governing the sale of these compounds can help business and academia better understand the challenges consumers may face in selecting products lawfully placed on the market, whilst identifying the unique challenges imposed from the marketing of Cannabis-based foods.

The impacts of potency, warning messages, and price on preferences for Cannabis flower products.

BACKGROUND: Recreational cannabis has been legalized in 11 states and Washington DC in the US. However, little is known about individual preferences for legal cannabis products. This study estimated the impacts of tetrahydrocannabinol (THC), cannabidiol (CBD), warning messages, and price on preferences for cannabis flowers. METHODS: A cross-sectional online survey with discrete choice experiments was implemented in October 2017. A sample of 2400 adults aged 21 years or older were recruited from 6 US states with recreational cannabis legalization, consisting of 1200 past-year nonusers and 1200 past-year users. Each respondent was randomly assigned to 12 discrete choice scenarios, each asking them to choose from an opt-out option and 3 cannabis flower products with varying levels in THC, CBD, warning messages, and price. The impacts of product attributes on individual choices were analyzed with nested logit regressions. RESULTS: Both cannabis nonusers and users preferred higher CBD and lower price. Users also preferred higher THC. The results on warning messages were mixed: graphic warning on drugged driving and text warning message had positive impacts on nonusers' and users' preferences for cannabis flowers, respectively, whereas FDA disapproval disclaimer had negative impacts on nonusers' preferences. Heterogeneities in preferences were revealed among nonusers by former use status and among users by reason of use. Particularly, medical cannabis users were not as responsive to THC as recreational cannabis users or dual users were. Regarding relative importance of the attributes, all respondents but medical cannabis users perceived price as the most important attribute (relative importance 51-64%), whereas medical cannabis users perceived CBD as the most important attribute (relative importance 47%). CONCLUSION: The findings indicated that product characteristics may have influences on US adults' choices of legal cannabis flower products and may deserve consideration for cannabis regulatory framework.

Cannabis use in Europe: Current trends and public health concerns.

In this contribution, I summarize recent trends of cannabis use in Europe and their public health implications. The first trend refers to an increase of treatment demand for cannabis problems by 76% while prevalence of cannabis use remained largely stable in the same period, based on available data. There are good reasons to assume that this trend reflects increases in the prevalence of cannabis use disorders, however, data to support this claim are not available. Potential drivers for a rising prevalence of cannabis use disorders comprise changes in consumption patterns and increasing levels of THC in available cannabis products. While an increasing prevalence of cannabis use disorders seem likely, the estimates of the Global Burden of Disease studies suggest the opposite. The second trend refers to an emerging market for cannabidiol (CBD) products in European countries, where regulations on CBD are lacking. Given the lack of data on users of CBD products, it can hardly be assessed if current abstainers will initiate using other cannabis products after trying CBD products for medicinal or recreational purposes. However, regulations should be implemented and enforced in order to make CBD products safer for consumers, for instance by ensuring reliable potency levels and by reducing the presence of toxic substances through quality control measures. In summary, a substantial transition of the epidemiology of cannabis use is under way, accompanied by changes in potency, treatment demand and new products. In order to assess the public health implications of this transition, data on population exposure of specific cannabinoids are required.

Oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: a study protocol for a pilot and definitive randomised double-blind placebo-controlled trial (CannabisCINV).

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) remains an important issue for patients receiving chemotherapy despite guideline-consistent antiemetic therapy. Trials using delta-9-tetrahydrocannabinol-rich (THC) products demonstrate limited antiemetic effect, significant adverse events and flawed study design. Trials using cannabidiol-rich (CBD) products demonstrate improved efficacy and psychological adverse event profile. No definitive trials have been conducted to support the use of cannabinoids for this indication, nor has the potential economic impact of incorporating such regimens into the Australian healthcare system been established. CannabisCINV aims to assess the efficacy, safety and cost-effectiveness of adding TN-TC11M, an oral THC/CBD extract to guideline-consistent antiemetics in the secondary prevention of CINV. METHODS AND ANALYSIS: The current multicentre, 1:1 randomised cross-over, placebo-controlled pilot study will recruit 80 adult patients with any malignancy, experiencing CINV during moderate to highly emetogenic chemotherapy despite guideline-consistent antiemetics. Patients receive oral TN-TC11M (THC 2.5mg/CBD 2.5 mg) capsules or placebo capsules three times a day on day -1 to day 5 of cycle A of chemotherapy, followed by the alternative drug regimen during cycle B of chemotherapy and the preferred drug regimen during cycle C. The primary endpoint is the proportion of subjects attaining a complete response to CINV. Secondary and tertiary endpoints include regimen tolerability, impact on quality of life and health system resource use. The primary assessment tool is patient diaries, which are filled from day -1 to day 5. A subsequent randomised placebo-controlled parallel phase III trial will recruit a further 250 patients. ETHICS AND DISSEMINATION: The protocol was approved by ethics review committees for all participating sites. Results will be disseminated in peer-reviewed journals and at scientific conferences. DRUG SUPPLY: Tilray. PROTOCOL VERSION: 2.0, 9 June 2017. TRIAL REGISTRATION NUMBER: ANZCTR12616001036404; Pre-results.

What's new in multiple sclerosis spasticity research? Poster session highlights.

Each year at the Multiple Sclerosis Experts Summit, relevant research in the field of multiple sclerosis spasticity is featured in poster sessions. The main studies presented at this year's meeting are summarized herein.

A cost-effectiveness model for the use of a cannabis-derived oromucosal spray for the treatment of spasticity in multiple sclerosis.

BACKGROUND: Severity of spasticity in multiple sclerosis (MS) directly correlates with the level and cost of care required. This study assessed whether a tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray for treatment of moderate-severe MS spasticity is a cost-effective use of healthcare resources in Wales. METHODS: A Markov model was developed to compare THC/CBD plus standard of care (SoC) treatments with SoC alone. RESULTS: At 30 years, total incremental cost for THC/CBD plus SoC treatment was estimated at £3,836/patient (ICER: £10,891/quality-adjusted life year [QALY]). Hospital admission costs had the greatest effect on the base case ICER. Inclusion of carer cost led to incremental cost of -£33,609/patient (ICER: -£95,423/QALY). CONCLUSIONS: The THC/CBD spray was found to be cost-effective for the treatment of spasticity in MS, and dominant, if home carer costs were included. Use of THC/CBD has the potential to generate cost savings by significantly improving the symptoms of moderate to severe MS spasticity.