A Phase I Trial to Determine the Pharmacokinetics, Psychotropic Effects, and Safety Profile of a Novel Nanoparticle-Based Cannabinoid Spray for Oromucosal Delivery

Lorenzl, Stefan; Gottwald, Franz; Nistler, Angelika; Brehm, Laura; Grötsch, Renate; Haber, Georg; Bremm, Christian; Weck, Christiane; Trummer, Carina; Brand, W.

doi:10.1159/000521352

Cited by 3 publications

(3 citation statements)

References 22 publications

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“…Those works included participants in the following age ranges: 14–15 (1, 0.6%), 16–17 (1, 1.3%), 18–19 (25, 16.1%), 20–29 (79, 51%), 30–39 (19, 12.3%), 40–49 (10, 6.5%), 50–59 (9, 5.8%), and 60–69 (10, 6.5%). In addition, 37 publications 16 , 32 – 35 , 37 – 63 , 65 , 66 , 68 – 70 reported age ranges including 907 participants. The minimum age considered was 15 and maximum was 79 years old.…”

Section: Resultsmentioning

confidence: 99%

Measuring the diversity gap of cannabis clinical trial participants compared to people who report using cannabis

Barkholtz

Bates

2023

Sci Rep

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Little is known about the demographics of people who use cannabis, including how use trends within population subgroups have evolved over time. It is therefore challenging to know if the demographics of participants enrolled in cannabis clinical trials are representative of those who use cannabis. To fill this knowledge gap, data from the National Survey on Drug Use and Health (NSDUH) on “past-month” cannabis use across various population subgroups in the United States was examined from 2002 to 2021. The most notable increases in “past-month” cannabis use prevalence occurred in those aged 65 and older (2,066.1%) and 50–64-year-olds (472.4%). In 2021, people reporting “past-month” cannabis use were 56.6% male and 43.4% female. Distribution across self-reported race and ethnicity was 64.1% White, 14.3% Black, 14.1% Hispanic, and 3.1% more than one race. And many ages were represented as 24.4% were 26–34, 24.1% were 35–49, 22.4% were 18–25, and 17.6% were 50–64 years old. To understand if these population subgroups are represented in cannabis clinical trials, participant demographics were extracted from peer-reviewed clinical trials reporting on pharmacokinetic and/or pharmacodynamic models of cannabis or cannabinoids. Literature was grouped by publication year (2000–2014 and 2015–2022) and participant prior exposure to cannabis. Results identified that cannabis clinical trial participants are skewed toward overrepresentation by White males in their 20s and 30s. This represents structural discrimination in the research landscape that perpetuates social and health inequities.

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Section: Resultsmentioning

confidence: 99%

Measuring the diversity gap of cannabis clinical trial participants compared to people who report using cannabis

Barkholtz

Bates

2023

Sci Rep

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“…C. sativa L. usually forms alkyl cannabinoids, which by their structure represent a monoterpene–isoprene (C 10 ) moiety and a pentyl (C 5 ) side chain. The ring structure of cannabinoids is derived from geranyl pyrophosphate (ElSohly et al., 2017; Lorenzl et al., 2022). Cannabinoids can be extracted from botanical agents, mainly C. sativa L. and C. indica L. They can also be isolated from endocannabinoids formed in a living organism's brain or peripheral tissues.…”

Section: Cannabinoidsmentioning

confidence: 99%

Are cannabidiol (CBD) levels in consumer food products well tested?—A review

Siddiqui,

Fidan,

Stankov

et al. 2023

Food Frontiers

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There are differing views on cannabis and phytocannabinoid usage in diverse domains of application. This review explores the advantages and drawbacks of using cannabis and phytocannabinoids, including their effects on human health, in addition to highlighting the need for precise and repeatable analytical methods for quantifying controlled phytocannabinoids in consumer cannabidiol (CBD) products and foods. The composition and characteristics of the phytochemicals found in cannabis, the advantages and disadvantages of controlled and uncontrolled phytocannabinoids, and the need for regulation and standardization in the use of cannabis and products containing phytocannabinoids are all covered in this review of the pertinent literature. Cannabinoids used illegally can have negative consequences, but controlled phytocannabinoids found in consumer CBD products are relatively safe and unlikely to cause any adverse effects. It is necessary to restrict the amount of CBD in foods and consumer products in order to ensure safety. To measure the amount of restricted phytocannabinoids in these products, accurate analytical techniques are also required. In order to increase the use of cannabis among consumers, more research is needed to improve our understanding of the bioavailability and metabolic pathways of these compounds. Furthermore, consumers want clear and uniform federal rules governing the amount of CBD in food products in order to ensure correct dosing. To promote safe and responsible use, cannabis and phytocannabinoids must be carefully considered, regulated, and standardized. It is necessary for consumers to have clear, consistent standards governing the percentage of CBD in their food products. As a result, they would know the exact amount of CBD in their products.

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“…Medicinal cannabis has a favorable safety and tolerability profile, but there remains still a paucity of data, particularly in terms of chronic exposure. A phase I, open-label clinical trial in healthy male subjects was conducted to assess the pharmacokinetic and safety profile of an oromucosal cannabinoid spray (AP701) containing a lipid-based nanoparticular drug formulation standardized to THC (for details see [136]; this issue).…”

Section: Smart Lipids (Nano-carrier)mentioning

confidence: 99%

Chronic Pain and the Endocannabinoid System: Smart Lipids – A Novel Therapeutic Option?

Zieglgänsberger

Brenneisen

Berthele³

et al. 2022

Med Cannabis Cannabinoids

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The development of a high-end cannabinoid-based therapy is the result of intense translational research, aiming to convert recent discoveries in the laboratory into better treatments for patients. Novel compounds and new regimes for drug treatment are emerging. Given that previously unreported signaling mechanisms for cannabinoids have been uncovered, clinical studies detailing their high therapeutic potential are mandatory. The advent of novel genomic, optogenetic, and viral tracing and imaging techniques will help to further detail therapeutically relevant functional and structural features. An evolutionarily highly conserved group of neuromodulatory lipids, their receptors, and anabolic and catabolic enzymes are involved in a remarkable variety of physiological and pathological processes and has been termed the endocannabinoid system (ECS). A large body of data has emerged in recent years, pointing to a crucial role of this system in the regulation of the behavioral domains of acquired fear, anxiety, and stress-coping. Besides neurons, also glia cells and components of the immune system can differentially fine-tune patterns of neuronal activity. Dysregulation of ECS signaling can lead to a lowering of stress resilience and increased incidence of psychiatric disorders. Chronic pain may be understood as a disease process evoked by fear-conditioned nociceptive input and appears as the dark side of neuronal plasticity. By taking a toll on every part of your life, this abnormal persistent memory of an aversive state can be more damaging than its initial experience. All strategies for the treatment of chronic pain conditions must consider stress-related comorbid conditions since cognitive factors such as beliefs, expectations, and prior experience (memory of pain) are key modulators of the perception of pain. The anxiolytic and anti-stress effects of medical cannabinoids can substantially modulate the efficacy and tolerability of therapeutic interventions and will help to pave the way to a successful multimodal therapy. Why some individuals are more susceptible to the effects of stress remains to be uncovered. The development of personalized prevention or treatment strategies for anxiety and depression related to chronic pain must also consider gender differences. An emotional basis of chronic pain opens a new horizon of opportunities for developing treatment strategies beyond the repeated sole use of acutely acting analgesics. A phase I trial to determine the pharmacokinetics, psychotropic effects, and safety profile of a novel nanoparticle-based cannabinoid spray for oromucosal delivery highlights a remarkable innovation in galenic technology and urges clinical studies further detailing the huge therapeutic potential of medical cannabis (Lorenzl et al.; this issue).

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A Phase I Trial to Determine the Pharmacokinetics, Psychotropic Effects, and Safety Profile of a Novel Nanoparticle-Based Cannabinoid Spray for Oromucosal Delivery

Cited by 3 publications

References 22 publications

Measuring the diversity gap of cannabis clinical trial participants compared to people who report using cannabis

Measuring the diversity gap of cannabis clinical trial participants compared to people who report using cannabis

Are cannabidiol (CBD) levels in consumer food products well tested?—A review

Chronic Pain and the Endocannabinoid System: Smart Lipids – A Novel Therapeutic Option?

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