The U.S. Food and Drug Administration (FDA) has given approval for an investigational new drug (IND) application for a clinical trial to evaluate the viability of CBD for opioid use disorder.
Opioid use disorder affects over 16 million people worldwide. Over 2.1 million are in the United States alone. And there are over 120,000 deaths worldwide annually attributed to opioids. There are as many patients using opioids regularly as there are patients diagnosed with obsessive-compulsive disorder, psoriatic arthritis, and epilepsy in the United States.
Furthermore, from 2002 to 2017, there was a 22-fold increase in the total number of deaths involving fentanyl and other synthetic opioids, and more than a 7-fold increase in the number of deaths involving heroin. Emergency department visits for suspected opioid overdoses rose by 30 percent in the U.S. from July 2016 to Sept. 2017.
The opioid crisis was declared a nationwide Public Health Emergency on Oct. 27, 2017. And since that time it hasn’t seemed to get any better.
And a new clinical trial will determine if CBD may be helpful in the fight against this crisis.
What is OUD?
Opioids are a broad group of pain-relieving drugs that work by interacting with opioid receptors in your cells. When used carefully, under doctor supervision, opioid medications can safely help control acute pain. There are risks, though, when the medications are used incorrectly. Unfortunately, the careful management and control of these drugs is not always successful. People can quickly become addicted to these drugs.
Opioid use disorder (OUD) is characterized by the chronic use of opioids that causes clinically significant distress or impairment. It consists of an overpowering desire to use opioids even when they are no longer needed. Increased opioid tolerance and withdrawal symptoms are 2 other characteristics.
Opioid use disorder includes dependence and addiction with addiction representing the most severe form of the disorder.
Opioid use disorder is one of the most challenging forms of addiction facing the American healthcare system. This disease is typically treated with opioid replacement therapy using buprenorphine or methadone.
So, can CBD play a role in reducing the risk and helping people with OUD?
CBD for Opioid Use Disorder?
Thanks to its reported value as a natural pain reliever, CBD has long been suggested as a potential alternative to opioids.
- 46% who previously used opioids had given them up and switched to CBD
- 43% who previously used any prescription drugs had given them up and switched to CBD
- 74% said CBD was extremely effective or very effective in treating their medical conditions compared to other pharmaceuticals
And more recent research backs up those consumer reports. In 2019, the American Journal of Psychiatry released a groundbreaking study on using CBD to treat opioid addiction. And the results were very promising. Participants experienced significant reduction (2-3 fold) in cravings compared to those given the placebo.
But it goes even further than that.
Biotech pharma company Ananda Scientific Inc. announced earlier this month that the FDA has approved its application for a clinical trial evaluating Nantheia ATL5, an investigational drug using CBD as an adjunctive treatment for opioid use disorder. The study will be conducted at the University of California, Los Angeles (UCLA).
According to the company, this innovation may create new potential for CBD therapeutics, as it may have the ability to reduce opioid intake in patients being treated or addicted to opioids.
In a press statement, Dr. Edythe London, one of the principal investigators that have led the trial, said that this approval is a crucial milestone for the ongoing research into therapeutic benefit of CBD for opioid use disorder and reversal of the effects of the opioid epidemic in the United States, and worldwide.
Stay tuned for more on this developing story.