A biotech firm is testing a new drug which can act as an “antidote” for people who experience extreme paranoia or anxiety after getting too high.
This new experimental drug, known as ANEB-001, is a small-molecule cannabis antagonist that can quickly reverse the psychoactive effects of THC intoxication. Texas-based Anebulo Pharmaceuticals licensed this novel compound from another biotech firm and is hoping to market it as a treatment for acute cannabinoid intoxication (ACI). This official terminology refers to paranoia, nausea, anxiety, panic, psychosis, and other symptoms that can result from consuming too much THC.
“With no FDA approved therapeutic, ACI often requires lengthy emergency department stays with expensive follow-on interventions for neuropsychiatric complications such as anxiety and acute psychosis,” Anebulo CEO Simon Allen said in a statement. “We believe ANEB-001 will play a critical role in reducing the burden of ACI for the patient and the healthcare system.”
According to a study cited by Anebulo, there were an estimated 1.7 million cannabis-related emergency room visits in the US in 2019, up from around 450,000 in 2006. The company also predicts that this number will grow by 15% annually now that more states are legalizing weed. A more recent study suggested that cases of extreme cannabis-induced psychosis are actually exceedingly rare, though, only occurring in less than half of 1% of adult users.
Regardless of their prevalence, extreme levels of THC intoxication can be traumatic for inexperienced users, children, and people suffering from underlying mental health issues. For this reason, many physicians have expressed the desire for a cannabis antagonist that can quickly and safely provide immediate relief to someone undergoing an ACI crisis.
To investigate the safety and efficacy of their new product, Anebulo commissioned the Centre for Human Drug Research in the Netherlands to conduct a two-part Phase II clinical trial. In Part A of this experiment, researchers gave 60 healthy cannabis users an oral dose of 10.5mg of THC. The subjects were divided into three groups, who received either 100mg of ANEB-001, 50mg of the medicine, or a placebo.
Researchers monitored subjects' vital signs and asked them to self-report how high they felt, using a standard psychological assessment scale. Three-quarters of the subjects who received the placebo said that they felt high after taking THC, compared to 10% who took the 50mg dose of the “antidote” and 30% who received the 100mg dose. Subjects who took the new drug also showed milder central nervous system effects than those who received the placebo, including lower heart rates, decreased body sway, and increased awareness.
Based on these promising results, researchers conducted an additional experiment to explore whether a smaller dose of ANEB-001 could counteract a higher dose of THC. In this experiment, three groups of subjects were given 21mg of THC, twice the dose delivered in Part A. An hour later, subjects received either 30mg or 10mg of ANEB-001, or a placebo.
Again, subjects who received the placebo were more likely to report “feeling high” than the experimental groups. These smaller doses were also associated with a significant reduction in body sway and an increase in overall awareness compared to the placebo. Researchers did not observe a significant reduction in heart rate at these lower dosages, however.
“These new Part B data showed that 10mg of ANEB-001 reversed key symptoms of ACI, comparing favorably to our Part A data showing similar effects with 50mg and 100mg,” Allen said in a press release. “The 10mg data is even more impressive considering we doubled the THC challenge to 21mg in that cohort.”
While Anebulo is working to bring their new product to market, other researchers are testing a similar drug that can stop an acid trip in its tracks. Canadian biotech company MindMed is currently partnering with the University Hospital Basel in Switzerland to develop a “neutralizer” that can quickly counteract the long-lasting psychoactive effects of LSD.
For lower-tech options, the Arizona-based company Undoo claims its olivetol capsules can take off the edge from an anxious cannabis experience.
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