Dr. Doug Burgess has been treating substance use disorders for more than 20 years. He’s the medical director of addiction services at University Health in Kansas City.
He said he’s pretty much seen and treated it all — stimulant use disorder, alcohol use disorder, opioid use disorder. But then about 18 months ago, he started to see patients trickle in that has developed use disorders with 7-OH, which is short for 7-hydroxymitragynine.
“So, 7-OH is related to kratom, but is definitely different,” Burgess said. “The way I explain it to people… it's like the difference between having a cup of coffee and having caffeine that's concentrated into a pill form and very, very potent.”
“I do not think we can talk about regulation without also talking about access to treatment. This is a disease. People need help. If we don't offer treatment and access to care, then we're going to be creating big problems.”Dr. Doug Burgess, Medical Director of Addiction Services at University Health in Kansas City.
Kratom is a tree found in Southeast Asia that has a long history of medicinal use. Its leaves are often chewed on and brewed into a tea, which can produce a stimulant or opioid-like sedative effect, depending on the dose.
Burgess said there’s 40 or more active compounds in the plant. 7-OH is just one of those compounds and naturally occurs in very low concentrations in kratom. It acts on the same part of the brain as opioids, such as morphine, heroin or fentanyl.
But, in the last few years, products began to appear at gas stations, in head shop and online that contained a much more potent synthetic form of 7-OH.
“It's estimated that it's probably 14 times stronger than morphine, and it's also metabolized and broken down into other compounds that might be even stronger than morphine,” Burgess said. “So, when people think about this, like, it's available over the counter, and they think it's harmless, and they think if you can buy it at a gas station, you know what's the harm? Really quickly, they figure out that there's significant downsides.”
Burgess said that at this point he is regularly treating patients with 7-OH physical dependencies. Many of whom didn’t know what 7-OH was when they began using the substance.
“I have one person that I treat … she was going through perimenopausal symptoms, and people [said], ‘7-OH, it works great. It'll help you with your sleep. It'll help you with your anxiety,'” Burgess said. “That's someone who was completely naive and was absolutely harmed because someone she trusted told her … ‘Hey this is an over-the-counter supplement.'”
Luckily, Burgess said that 7-OH dependency does seem to respond to the treatments available for other opioid use disorders, and there’s no indication that naloxone, a medication that reverses opioid overdoses, wouldn’t be effective in the case of a 7-OH overdose.
But he does note that an overdose from 7-OH may not look the same as other opioid overdoses because it is often being used in tandem with other drugs, such as alcohol, and it isn’t available in a “pure form,” meaning it could be mixed with substances that impact other parts of the brain.
“There's [not] anything good about opioids, in general, but one thing that's nice about opioids … like fentanyl, heroin, morphine, prescription opioids: they're very clean in terms of they only act on the opioid receptors,” Burgess said. “With products like kratom and some of the other things that may be mixed in with 7-OH, they hit a lot of different receptors in the brain, and so some of the withdrawal that people experience when they're stopping these substances can look different.”
Burgess said there should be better regulation of these compounds, and he suggested it might be best if they are taken off the shelves. But he’s still worried about what options individuals who have developed 7-OH dependencies will be left with if that happens.
“I do not think we can talk about regulation without also talking about access to treatment,” Burgess said. “This is a disease. People need help. If we don't offer treatment and access to care, then we're going to be creating big problems.”
A rapidly changing legal status
Steven Hofer, the Special Agent in charge of the Drug Enforcement Agency’s St. Louis division, said the development of 7-OH is representative of the recent illicit drug market, which has focused more on the production of synthetic opioids.
“Substances that come from natural plants, heroin and cocaine … it all requires a few things. One is it requires a growing season,” Hofer said. “Synthetics that are made, the only hurdle when it comes to how much you can make is the purchase, of how much of the chemicals can I buy and get my hands on.”
He said synthetic opioids have also become more popular due to cheaper material costs, a higher potential profit margin and a higher potency. Hofer added that because it takes such a small amount of the drug to have the desired effect, it is also more efficient to smuggle into the country.
“So, you're talking about making a lethal dose of any of these synthetics for literally pennies, probably less than five cents, but can charge probably anywhere from on the cheap end, $5. Some places, maybe $30 per. So that's a lot of money to make,” Hofer said.
He added that because of the lack of regulation, no one can be sure what they are actually purchasing and ingesting with 7-OH.
"The millions of Americans who consume prescription pills, they know exactly what they're getting, and it's safe as long as it's followed by the directions," Hofer said. "The problem with a substance like 7-OH that is purchased at, for example, a gas station or from a friend — how can anybody be certain of what it is exactly that they are consuming? It would be, in my opinion, the same as playing Russian roulette."
"I think the best thing ... would be to, if they want, to contact their local police department or contact their local DEA office to ask if they know of an area drop-off location or when the next opportunity for that may may come be."Steven Hofer, Special Agent in Charge of the Drug Enforcement Administration’s St. Louis Field Division
This is the same class of drugs as heroin, LSD and marijuana. These drugs are considered highly addictive, have no accepted medical use and carry hefty felony penalties.
“This is about public safety. This is DEA stepping in along with our partners at FDA and HHS to help educate Americans and have everybody recognize that exposure to 7-OH could potentially be not just very dangerous, but deadly,” Hofer said.
On August 25, the U.S. Department of Justice announced that the three 7-OH related synthetic compounds were now schedule 1, but there was no mention of 7-OH itself being banned at certain thresholds.
According to a Missouri Department of Health & Human Services spokesperson, once the federal government makes a new rule, each state then has to develop and adopt its own emergency rules.
They said it is likely the state will be announcing rules of its own in the near future, which could potentially be broader than the federal regulations.
What will enforcement look like?
Until now, there has been little regulation and oversight of 7-OH and its related compounds, which individuals could legally purchase.
And the uncertainty about the current legal status of various compounds has left many stores and individuals confused about what is legal to purchase, sell and/or possess.
“I think unfortunately the DEA tends to act first by placing it in the schedule because then they have authority, you know, full legal authority over the substance, and the details, the practical details, tend to follow sometimes. And I think we're in that in between, said Kelly Gillespie, the Director of the Health Law Center at St. Louis University.
"The emergency scheduling action subjects the manufacture, distribution and possession of these substances to the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances."Press Release: Justice Department Announces Emergency Scheduling of Three Potent Opioid Compounds
She said, at this point, she’s not seen any guidance from the federal government about how to safely and legally dispose of the compounds if and when they become illegal be that amnesty boxes or drug take backs events.
“Certainly people are going to need some options,” Gillespie said. “But I don't think any plans have rolled out for that, as far as I'm aware.
Hofer suggested contacting local law enforcement agencies if a compound in your possession is moved to schedule 1. He also recommended making use of the next DEA National Take Back Day on October 24 or searching the DEA’s website for a local year-round drop-off location.
Gillespie said the changing legal landscape could put stores at risk of theft and individuals at risk of legal penalty if they do not stay on top of the legal changes. For example, she said, it could be possible for someone who legally purchased one of the now-schedule 1 products just weeks ago to be pulled over and receive a felony possession charge.
She said she hopes that law enforcement and prosecutors would have some grace and understanding amidst the changes, but, at the end of the day, that’s a “matter of prosecutorial discretion.”
Gillespie said, for now, as new rules around 7-OH and related compounds are being finalized and announced by both the federal and state government, people should store any 7-OH products in a secure location and wait for clearer guidance on whether it needs to be disposed of and how to do so safely and legally.
