The Food and Drug Administration (FDA) in the United States has authorized an application of an investigational drug for a clinical trial to test CBD as an adjuvant treatment for opioid use disorder.
Ananda Scientific Inc., a biotech pharma business, said in January 2022 that the FDA had approved a clinical trial for Nantheia ATL5, an investigational medicine that uses CBD as an adjuvant treatment for opioid use disorder. The research will take place at the University of California, Los Angeles (UCLA) (UCLA).
Nantheia ATL5 is an oral medicine with CBD (100mg) per soft gel capsule and uses Liquid Structure technology, which was licensed from an Israeli pharmaceutical company and improves CBD’s effectiveness and stability.
Preclinical and early clinical investigations have shown that ANANDA’s Liquid Structure technology improves the efficacy and stability of CBD. According to the business, this invention could open up new opportunities for CBD treatments by reducing opioid intake in individuals who are being treated for or addicted to opioids.
In a news statement, ANANDA’s Chief Executive Officer, Sohail R. Zaidi, said, “This is the fourth IND approval for our investigational drug Nantheia product line, and it further re-enforces our vision of developing CBD as a therapeutic for several key indications.”
FDA Approves Trial To Treat Opioid Addiction With CBD
Medicine must be approved by the FDA before it can be transported or disseminated throughout the United States, according to current federal law. The FDA, on the other hand, can accept an IND application, which exempts the firm from this requirement and permits it to send the experimental drug to clinical investigators in other states in the United States.
According to the FDA, the sponsor’s major purpose during early pre-clinical research of a new medicine is to evaluate whether the product is adequately safe for initial use in people and whether the chemical has a pharmacological activity that warrants commercial development. When employed in limited, early-stage clinical studies only when a product is assessed as an ideal option for further development, the corporation can collect the data and information needed to establish the impact on humans.
Dr. Edythe London, one of the project’s primary investigators, said in a news release that the IND approval for Ananda’s clinical trial is a critical milestone for ongoing research into therapeutic alternatives for opioid use disorder and reversal of the opioid epidemic’s impacts.
What Does The Research Say?
According to the Centers for Disease Control and Prevention (CDC), nearly 841,000 people have died since 1999 from a drug overdose, and over 70% of drug overdose deaths in 2019 involved an opioid.
Pre-clinical animal studies led by Dr. Yasmin Hurd, who is the Director of the Addiction Institute at Mount Sinai and the Ward-Coleman chair of Translational Neuroscience have revealed that CBD reduces cue-induced heroin seeking behavior during drug cessation, which is linked to craving incubation.
The debate over CBD as a remedy for the opioid problem, on the other hand, is still raging. While some believe that cannabis could provide an alternative to opioids for treating chronic pain and hence minimize opioid overdoses and deaths, others believe that cannabis could help people who are addicted to opioids overcome their addiction.
The FDA issued warning letters to two companies in 2020 for selling unapproved CBD products in ways that violated the Federal Food, Drug, and Cosmetic Act (FD&C Act).
In a news release, FDA Principal Deputy Commissioner Amy Abernethy said, “The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claim .”
For the FDA, there remain many unanswered questions about the science, safety, effectiveness, and quality of unapproved CBD products. The only treatment entirely approved by the FDA in 2018 is Epidiolex, a THC-free drug with high quantities of CBD created by GW Pharmaceuticals. In patients two years of age and older, it is successful in treating two rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome.
Buying CBD For Opioid Addiction
Many businesses have invested money in researching CBD and hemp-based drugs to treat a variety of diseases, including morning sickness, in recent years. Several businesses, on the other hand, contaminate their products to save money on manufacturing costs. In exchange, they supply lower-cost products to their customers. Contaminated things can have catastrophic consequences. As a result, before purchasing any goods, it is critical to conduct extensive research on the brand.
When purchasing a brand, the following criteria must be taken into account:
- Look into whether the business provides third-party lab test results for its items.
- Check the product label to see if all of the ingredients are stated.
- Check to see whether their products contain less than 0.3% THC.
Conclusion On CBD For Opioid Addiction
HempDepotCo is one of the few CBD companies that adhere to all regulations while also providing high-quality CBD. HempDepot sells CBD from some well-known companies, as well as its CBD products.CBD Facial Serums, CBD Gummies, and Hemp Derived Flavoured Syrup are some of the most popular hemp and CBD products to deal with opioid addiction.