New Drug May Treat Patients Who Get Too High

A new drug, ANEB-001, is being developed by Anebulo Pharmaceuticals to treat Acute Cannabinoid Intoxication (ACI), a condition that can occur when large quantities of THC are consumed, leading to symptoms such as anxiety, paranoia, and panic attacks. ANEB-001 is a THC antagonist that binds to the brain's CB1 receptors without activating them, thereby inhibiting the effects of THC. Currently in Phase 2 clinical trials, ANEB-001 has shown promising results, with subjects experiencing significantly lower levels of intoxication. If approved, the drug could be available in U.S. emergency rooms by 2025, potentially reducing the number of costly ER visits related to ACI.
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While cannabis has been shown to offer multiple therapeutic benefits, one drawback is its potential to induce anxiety and paranoia in some users. When unpleasant symptoms occur due to consuming large quantities of THC, it is referred to as Acute Cannabinoid Intoxication (ACI), and it can lead to people seeking emergency medical treatment.

Now, a new drug is in development by Anebulo Pharmaceuticals that may treat ACI by inhibiting the effects of THC. In this article, CannaMD explores how the new medication, called ANEB-001, works and what it could mean for the future of cannabis-related hospital visits.

How Can A Drug Prevent Getting Too High?

As cannabis legalization continues to spread across the United States, more people are using marijuana for both medicinal and recreational purposes. With this increase in use, there has also been an uptick in ER visits related to ACI.

Patients who present with ACI are typically first-time consumers, children who mistakenly ingested THC edibles, or experienced cannabis users who accidentally consumed more THC than their ideal dose. Symptoms of ACI can include anxiety, paranoia, panic attacks, and a host of uncomfortable physical symptoms. These effects are caused by too many THC molecules in the bloodstream binding to cannabinoid receptors in the brain (called CB1 receptors), leading to an over-activation of the endocannabinoid system that can last several hours until the body fully metabolizes the THC.

ACI is rarely life-threatening, and the symptoms will resolve over time without medical intervention. However, the experience can be both incredibly distressing and costly for anyone who finds themselves in the ER due to these symptoms. Fortunately, ANEB-001 offers a potential solution to this problem.

ANEB-001 is a THC antagonist, meaning it works by binding to the brain’s CB1 receptors without activating them. This prevents THC from binding to the sites and, as a result, helps to reduce or eliminate the negative effects of too much THC in the bloodstream.

Ongoing Clinical Trials

ANEB-001 is currently in Phase 2 clinical trials, conducted by the Center for Human Drug Research in the Netherlands. In Phase 1 of the trials, subjects consumed 10.5 mg of THC and received either a 50 mg dose of ANEB-001, a 100 mg dose of ANEB-001, or a placebo, prior to undergoing several tests that measured cognitive function and levels of intoxication.

The results showed that subjects who received ANEB-001 experienced significantly lower levels of intoxication than those who received the placebo.

During Phase 2, researchers will double the dose of THC to 21 mg and lower the dosage of ANEB-001 to 10 and 30 mg. While only two cohorts have completed testing so far, the results show that ANEB-001 is effective at lower doses and with mild side effects. Researchers are optimistic about the drug’s efficacy and state:

Based on blinded safety data, adverse events in Cohorts 1 and 2 were mild and transient, except for two cases of moderate dizziness in Cohort 1 likely attributable to THC.

This phase is still underway, and researchers plan to enroll at least six cohorts of up to 15 subjects each before moving to the next phase of clinical trials.

Next Steps

Findings from the first two phases of the clinical trials report that ANEB-001 typically works to reduce the effects of a subject’s THC-induced high within one hour. Phase 3 of the trials will test the drug an hour after THC consumption to more accurately simulate a real-world scenario.

After clinical trials are complete, Anebulo Pharmaceuticals will seek FDA approval for ANEB-001, with the aim of distributing the anti-high drug to emergency rooms in the United States by 2025. If the drug is approved, it could be a valuable tool in preventing lengthy and costly ER visits for ACI patients by reducing their symptoms rapidly with one simple medication.

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Updated: May 29, 2024

Article Written By:

Nikole Beach

Nikole Beach is a freelance health writer with a Bachelor of Science in biology from Oregon State University. As an advocate for natural, science-backed medicine, Nikole has a passion for spreading awareness by breaking down complex ideas for everyone to understand and enjoy. Her favorite area of cannabis research involves the use of marijuana to treat anxiety disorders.


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