This study is being done to assess the feasibility of administrating Δ9-THC and Δ8-THC isolates and simultaneously adopting several data harmonization measures to generate uniquely translatable data. This project aims to (1) evaluate the feasibility and acceptability of administering ∆9-THC and Δ8-THC isolates using standardized cannabis dosing units to quantify ∆9-THC and Δ8-THC pharmacokinetics; and (2) evaluate the feasibility and acceptability of adopting standardized impairment detection methods and driving performance definitions and measures on quantifying ∆9-THC and Δ8-THC driving impairment compared to a placebo.

Start Date01 Nov 2024

Sponsor / Collaborator

University of Wisconsin Madison

NCT05672342 / WithdrawnEarly Phase 1IIT

A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy

This clinical trial tests how well phytocannabinoids (cannabidiol [CBD] and tetrahydrocannbinol [THC]) work in reducing chronic chemotherapy-induced peripheral neuropathy (CIPN) in breast and colon cancer survivors. Neuropathy is the most common neurological symptom reported by cancer patients due to treatment. A variety of pharmacologic treatments have been evaluated to alleviate CIPN symptoms; however, no definitive treatment has been found to successfully treat all the symptoms of CIPN. Therefore, investigators continue to seek other possible treatment options including cannabis. Phytocannabinoids may be a particularly useful intervention for cancer patients given the limited effective treatments for CIPN. In addition, cannabis-based medicines have become tremendously popular as both cancer patients and clinicians are seeking therapies with fewer potential risks of dependency and other side effects. This trial is being done to provide cancer patients and clinicians with reliable information to help guide their use of phytocannabinoids to manage the tremendous distress and pain experienced by many cancer patients, which impacts their long-term quality of life.

Start Date06 Jul 2024

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06218550 / RecruitingPhase 1IIT

The Effect of Delta-8-THC vs Delta-9-THC on Simulated Driving Performance and Measures of Impairment

Delta-8-THC is an isomer of delta-9-THC that has become widely available due to the legalization of hemp and its derivatives. Very little controlled research has been conducted with delta-8-THC and some research suggests it produces similar effects to delta-9-THC, albeit at lower potency. The present study will evaluate the dose effects of delta-8-THC, compared with delta-9-THC, on simulated driving performance, field sobriety tests, cognitive performance, and biomarkers of exposure to cannabinoids. The results will inform policy and education related to impairment due to acute delta-8-THC exposure via vaporization and oral ingestion.

Start Date01 Jul 2024

Sponsor / Collaborator

The Johns Hopkins University

[+1]

100 Clinical Results associated with Delta-8-THC

100 Translational Medicine associated with Delta-8-THC

100 Patents (Medical) associated with Delta-8-THC

453

Literatures (Medical) associated with Delta-8-THC

01 Jan 2025·ADDICTIVE BEHAVIORS

Derived psychoactive cannabis product perceptions and use among a sample of US young adults

Article

Author: Cavazos-Rehg, Patricia A ; LoParco, Cassidy R ; Rossheim, Matthew E. ; Yang, Y Tony ; LoParco, Cassidy R. ; Rossheim, Matthew E ; Yang, Y. Tony ; Berg, Carla J. ; Cui, Yuxian ; McCready, Darcey M. ; Romm, Katelyn F ; Berg, Carla J ; Wang, Yan ; Romm, Katelyn F. ; McCready, Darcey M ; Cavazos-Rehg, Patricia A.

AIMS:

To characterize derived psychoactive cannabis product (DPCP) perceptions and use among US young adults.

METHODS:

We analyzed 2023 survey data among 4,031 young adults (ages 18-34), comprising ∼ 50 % reporting past-month cannabis use. Multivariable regressions examined sociodemographics, cannabis use, and DPCP risk perceptions in relation to: 1) past-month DPCP use (yes/no), 2) past-month number of DPCP use days, and 3) among those reporting no past-month DPCP use, future likelihood of DPCP use.

RESULTS:

In this sample (M_age = 26.3, 59.8 % female, 64.9 % White, 19.4 % Hispanic), DPCP awareness (67.5 %), lifetime use (41.7 %), and past-month use (24.4 %) differed by past-month cannabis use versus nonuse (87.0 % vs 48.8 %, 68.7 % vs 15.9 %, 45.6 % vs 4.2 %, respectively). Those aware learned about them mainly from friends/family (44.5 %) and believed DPCPs were required to be tested and approved to be safe (70.3 %) or were approved by the US Food and Drug Administration (59.0 %). Those who ever used DPCPs most often used delta-8 (69.7 %) and delta-9 (44.4 %) THC and for curiosity (55.5 %), belief of federal legality (34.1 %), and friends' suggestion (34.0 %). Correlates of past-month DPCP use, using more frequently, and higher likelihood of future use were: lower DPCP perceived harm and higher perceived addictiveness. Living where non-medical cannabis was illegal, higher perceived social acceptability, being Black (vs. White), and past-month cannabis use were also correlated with past-month use (but not frequency) and future likelihood of use.

CONCLUSIONS:

Efforts are needed to better understand DPCPs' risks and correct consumer misperceptions. Relatedly, DPCP regulation, including marketing and distribution, is crucial.

01 Nov 2024·Cancer Medicine

Cannabis Use Among Cancer Patients During Active Treatment: Findings From a Study at an NCI‐Designated Cancer Center

Article

Author: Penedo, Frank ; Diggs, Bria‐Necole A. ; Martinez, Claudia ; Marrakchi El Fellah, Ranya ; McCarley, Connor ; Vidot, Denise C. ; Baral, Amrit

ABSTRACT:

Objective:

This study aims to describe patterns, sources, and reasons for cannabis use among cancer patients during active treatment (+CDTX) compared to no‐use during active treatment (−CDTX).

Methods:

Data are from 385 surveys collected via REDCap during phase I of an ongoing study among adult cancer patients seen at an NCI‐designated comprehensive cancer center within the last 5 years of treatment. A harmonized survey was created with 11 other NCI centers to assess cannabis use patterns, sources, and reasons for use. Sociodemographics and cancer details were also collected via self‐report. Descriptive statistics were calculated and stratified by +/−CDTX. Chi‐squared tests were conducted to compare proportions between groups.

Results:

Among the sample [49.5 years (SD 15.9); 53.0% male; and 41.6% Hispanic/Latino], 41.0% + CDTX and 59.0% −CDTX. A majority (71.8%) of +CDTX initiated use before diagnosis versus 44.1% in −CDTX (p < 0.0001); patients diagnosed with stage 4 cancer had a statistically significant higher prevalence of +CDTX (60.0%; p = 0.003); 53.3% in radiation reported +CDTX compared to 42.8% in chemotherapy, and 36.4% in immunotherapy. Dispensaries and local dealers were the top sources of cannabis in both groups. Among +CDTX, 44.3% consumed cannabis at least once a day DTX, dominant cannabinoids used were CBD (35.2%), Delta‐8‐THC (18.3%), and CBD + THC ratio (14.1%); 12.7% were unsure what they consumed. Joints were the most common inhalation method (61.5%), and store‐bought candy was the most common edible (39.2%). Depression/mood, pain, and enjoyment were the top three reasons for +CDTX compared to enjoyment, depression/mood, and nausea/upset stomach in −CDTX (p = 0.02).

Conclusions:

Patterns, sources, and reasons for cannabis use varied between +CDTX and ‐CDTX. Future studies should examine the impacts of cannabis and specific cannabinoids on cancer treatment, drug interactions, survival outcomes, and quality of life.

01 Oct 2024·Cannabis and cannabinoid research

Pharmacological Characterization of the Endocannabinoid Sensor GRAB_eCB2.0

Article

Author: Stella, Nephi ; Bruchas, Michael R ; Dong, Ao ; Land, Benjamin B ; Sarroza, Dennis ; English, Anthony ; Singh, Simar ; Zweifel, Larry ; McGrory, Maya ; Li, Yulong

Introduction: The endocannabinoids (eCBs), 2-arachidonoylglycerol (2-AG) and arachidonoyl ethanolamine (AEA), are produced by separate enzymatic pathways, activate cannabinoid (CB) receptors with distinct pharmacological profiles, and differentially regulate pathophysiological processes. The genetically encoded sensor, GRAB_eCB2.0, detects real-time changes in eCB levels in cells in culture and preclinical model systems; however, its activation by eCB analogues produced by cells and by phyto-CBs remains uncharacterized, a current limitation when interpreting changes in its response. This information could provide additional utility for the tool in in vivo pharmacology studies of phyto-CB action. Materials and Methods: GRAB_eCB2.0 was expressed in cultured HEK293 cells. Live cell confocal microscopy and high-throughput fluorescent signal measurements. Results: 2-AG increased GRAB_eCB2.0 fluorescent signal (EC₅₀=85 nM), and the cannabinoid 1 receptor (CB₁R) antagonist, SR141716 (SR1), decreased GRAB_eCB2.0 signal (IC₅₀=3.3 nM), responses that mirror their known potencies at the CB₁R. GRAB_eCB2.0 fluorescent signal also increased in response to AEA (EC₅₀=815 nM), the eCB analogues 2-linoleoylglycerol and 2-oleoylglycerol (EC₅₀=632 and 868 nM, respectively), Δ⁹-tetrahydrocannabinol (Δ⁹-THC), and Δ⁸-THC (EC₅₀=1.6 and 2.0 μM, respectively), and the artificial CB₁R agonist, CP55,940 (CP; EC₅₀=82 nM); however their potencies were less than what has been described at CB₁R. Cannabidiol (CBD) did not affect basal GRAB_eCB2.0 fluorescent signal and yet reduced the 2-AG stimulated GRAB_eCB2.0 responses (IC₅₀=9.7 nM). Conclusions: 2-AG and SR1 modulate the GRAB_eCB2.0 fluorescent signal with EC₅₀ values that mirror their potencies at CB₁R, whereas AEA, eCB analogues, THC, and CP increase GRAB_eCB2.0 fluorescent signal with EC₅₀ values significantly lower than their potencies at CB₁R. CBD reduces the 2-AG response without affecting basal signal, suggesting that GRAB_eCB2.0 retains the negative allosteric modulator (NAM) property of CBD at CB₁R. This study describes the pharmacological profile of GRAB_eCB2.0 to improve interpretation of changes in fluorescent signal in response to a series of known eCBs and CB₁R ligands.

News (Medical) associated with Delta-8-THC

07 May 2024

·www.sciencedaily.com

New study finds increase in exposures to synthetic tetrahydrocannabinols among young children, teens, and adults

A sharp rise in exposures to synthetic cannabis products among youth -- some leading to hospitalization -- highlights the need for increased education around the dangers of exposure and increased focus on safe storage and packaging. A sharp rise in exposures to synthetic cannabis products among youth -- some leading to hospitalization -- highlights the need for increased education around the dangers of exposure and increased focus on safe storage and packaging, according to pediatricians and researchers at Nationwide Children's Hospital and the Central Ohio Poison Center. A new study conducted by researchers at the Center for Injury Research and Policy of the Abigail Wexner Research Institute at Nationwide Children's Hospital and the Central Ohio Poison Center examined trends in calls to poison centers across the country for exposures to different types of tetrahydrocannabinol (THC): delta-8 THC, delta-10 THC and THC-O acetate. These products are often referred to as "diet weed" or "hemp products," which leads to a misperception that they are safer alternatives to the more regulated and more abundant delta-9 THC. The study, published in Clinical Toxicology, found increases in the number of exposures in multiple age groups, with unintentional ingestions by young children being especially concerning. "Many people don't realize how toxic these products can be, especially to young children. One in four children needed to be hospitalized after exposure," said Hannah Hays, MD, co-author of the study, medical director of the Central Ohio Poison Center and faculty of the Center for Injury Research and Policy at Nationwide Children's. "If someone vapes, smokes, eats edibles or drinks infused beverages with delta-8, delta-10 THC or THC-O, all of those products should be stored up, away, and out of sight and reach of children, preferably in a locked container. These products should never be used in front of kids who might mistake them for food or drinks that they are allowed to have." Data Highlights According to the study: Safe Storage Pediatricians and other health care providers should continue to counsel patients and their families about the potential dangers of these products and the importance of safe storage practices, experts recommend: Safe packaging Study investigators also highlight inconsistent regulations of these products from state to state. Because the United States Food and Drug Administration currently does not regulate manufacturing of these products, contaminants such as heavy metals, solvents or pesticides may be found in them and may not be listed on product packaging. In addition, in many states, these products may not have the packaging or labeling requirements that delta-9 THC products have. While at least 14 states have banned or regulated the sale of these products, they are still available to the public online and in locations like gas stations and small convenience stores. In many places, there may be little to no regulation, with retailers often setting their own minimum purchasing age. "The current patchwork of state regulations has led to an environment that allows for easily available products that may have unlisted contaminants, inaccurate labels and packaging that can be appealing to children" said Christopher Gaw, MD, co-author of the study, pediatric emergency medicine physician and faculty member of the Center for Injury Research and Policy at Nationwide Children's. "We need clearer regulation of these products with better oversight and enforcement."

02 May 2024

·www.prnewswire.com

3CHI Demonstrates Safety and Potential Benefits of Delta 8 THC in Comprehensive Study

INDIANAPOLIS, May 2, 2024 /PRNewswire/ -- 3CHI is proud to announce the successful conclusion of a detailed tolerability and safety assessment of its Platinum Delta 8 THC oil, conducted in collaboration with Hera Biolabs. This pivotal study further confirms the safety of Delta 8 THC and showcases 3CHI's continued pioneering scientific research within the cannabinoid sector. This is the first in a series of tests that 3CHI is conducting to evaluate and further prove the safety and efficacy of its products. Continue Reading In this detailed study, Sprague Dawley rats were administered various doses of 3CHI's 99% pure Platinum Delta 8 THC oil, with quantities adjusted to reflect human equivalents for an average 70 kg individual, ranging from 10 mg to 500 mg. Throughout the entire study, the rats displayed no significant adverse effects, thus confirming the product's safety at all administered doses. Importantly, the study also observed promising beneficial effects that will be explored in future clinical trials. 3CHI Demonstrates Safety and Potential Benefits of Delta 8 THC in Comprehensive Study Post this Justin Journay, CEO of 3CHI, stated, "This study bolsters the safety profile of our Delta 8 THC and illustrates that the criticisms leveled against delta 8 THC products and the broader hemp industry lack scientific basis and are primarily fueled by competitors' profit-driven motives—many of whom are now, hypocritically, selling hemp products." He further noted, "Marijuana companies and their affiliated testing labs are a primary source of much of the misinformation found in the hemp industry. They simply don't have the competency to keep up with the rapid scientific advancements of the hemp industry and have fallen back on fearmongering and demonstrably false prohibitionist tactics in order to protect falling market share." This study provides strong validation for the safety of 3CHI's Platinum Delta 8 THC oil, reinforcing its reliable safety profile even when used beyond recommended dosages. 3CHI continues to set the standard in the industry, emphasizing safety, transparency, and scientific integrity. Our proactive approach to research and unwavering commitment to quality set us apart in the dynamic cannabis market. For additional information or to learn more about 3CHI's dedication to continuous quality and innovation, please visit our website: . Contact: [email protected] SOURCE 3Chi

Clinical ResultClinical Study

23 Apr 2024

·www.biospace.com

Scientists Develop Proprietary Technology, Addressing Issues on the Rise with Unregulated CBD and Delta-8-THC based Products

Greenville, SC, April 23, 2024 – Products containing cannabidiol (CBD) and other legal hemp-derived THC alternatives have become increasingly popular and are appearing in stores and online throughout the United States. Given the prohibited status of Delta-9-THC in 22 states, usage of Delta-8-THC in particular, and CBD have become prevalent in the marketplace due to their similar but less psychoactive biological effects. These products are highly unregulated and have led to concerns regarding cannabinoid composition and overall safety. Additionally, usage of these products has made drug testing complicated to interpret because the chemical structures are similar and cannot be differentiated by standard drug testing methods. Luxor Scientific, LLC and Clearwater BioTech, LLC are working together to tackle these concerns with hemp-derived cannabinoid products. Luxor Scientific, LLC, a full-service medical and research laboratory, has designed the CannabisConfirm™ panel, a first of its kind urine testing method to provide evidence for employers and healthcare providers as to whether an individual has consumed Delta-9-THC, Delta-8-THC, CBD and/or other cannabinoids. Compared to traditional laboratory practices, CannabisConfirm™ gives practitioners and employers the ability to identify legal versus illicit cannabis use. It is critical for healthcare providers and employers alike to be able to ensure that toxicology tests accurately represent a patient or prospective employee’s use of cannabis products. Sister company, Clearwater BioTech is an environmental and product testing laboratory that provides testing for all sectors of the cannabis and natural products market. Commercially available Delta-8 products are created in labs from CBD using a broad mixture of chemicals, such as pesticides, petroleum, and unknown ingredients. As Delta-8 products land on the shelves of local gas stations and convenience stores, it is important to validate the claims made to customers about the content and safety of products that they are consuming. Farmers, product formulators, consumers, retailers, and regulators work with Clearwater Biotech to ensure the composition and safety of cannabinoid products as well as their adherence to local and national regulations. “We are proud to bring our technology to the forefront of ensuring the safety of our community,” said Dr. Marion Snyder, PhD, Chief Science Officer and founding partner of Luxor Scientific and Clearwater Biotech. “With the increase in use of cannabis products, our scientists have developed methods that not only confirm the safety and contents of cannabis products, but the proper and informed use of these products as well.” About Luxor Scientific: Delivering better information faster, Luxor Scientific is a CAP Accredited Laboratory. With an in-house research and development team and leading scientists, Luxor serves hospitals & nursing facilities, clinics, medical practitioners, laboratories & universities, and commercial & governmental organizations with cutting edge diagnostic testing solutions for improved patient outcomes. For more information about Luxor Scientific, please visit . About Clearwater BioTech: Clearwater BioTech is a Cannabis, Psychedelics, & Environmental Testing Laboratory headquartered in Greenville, SC which has been servicing South Carolina’s hemp program since it’s initiation in 2018. It provides laboratory and related services to farmers, handlers and processors while being committed to delivering the highest value to the industry in terms of science, service and cost. For more information, please visit .

100 Deals associated with Delta-8-THC

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Indication	Highest Phase	Country/Location	Organization	Date
Nausea	Phase 2	-	Teva Pharmaceutical Industries Ltd.	-
Vomiting	Phase 2	-	Teva Pharmaceutical Industries Ltd.	-

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