There’s been a steady surge of interest in how and why psychedelics work to potentially cure addiction, especially alcohol addiction, also called alcohol use disorder (AUD). It is becoming one of the more interesting developments that mainstream medicine is watching, as more and more evidence becomes available.
In fact, it was LSD that was the original psychedelic substance researchers hoped to use to treat AUD, with some clinical success between 1966 and 1970. But as with much of the current psychedelics clinical trials, there is more to learn about which psychedelic is best, and how it works, for treating AUD.
New NYU Studies
According to a new study by the NYU Grossman School of Medicine, psilocybin may play a crucial role in treating AUD. In the study, 93 men and women with alcohol dependence were given two doses of psilocybin—83 percent reduced their heavy drinking within an 8-month period. The study concluded that psilocybin administered in combination with psychotherapy “produced robust decreases in the percentage of heavy drinking days over and above those produced by active placebo and psychotherapy,” and the results “provided support for further study of psilocybin-assisted treatment for AUD.” Researchers also said that this AUD research may prove useful in treating other addictions such as cigarette smoking and abuse of cocaine and opioids.
Michael Bogenschutz, director of the New York University (NYU) Langone Center for Psychedelic Medicine and senior author on the study, said that NYU would launch a multisite trial with more than 200 participants starting early next year and, depending on the results, planned to eventually submit the treatment to the Food and Drug Administration (FDA) for approval. NYU also filed a provisional patent application based on the work, he added in an interview for Stat News.
AUD is one of the most prevalent mental disorders globally. According to the 2019 National Institute on Alcohol Abuse and Alcoholism (NIAAA), 14.5 million people ages 12 and older had AUD. Worldwide, alcohol use has increased over the past three decades and is expected to continue to do so, both in its prevalence and level of use.
According to the NIAAA, the latest science shows that AUD can cause lasting changes in the brain. And there are only four well-known pharmacological treatments approved for AUD—Disulfiram, Acamprosate, Naltrexone, and Nalmefene—each chalking up only modest success.
So the race is on now to find the best psychedelic for treating AUD, in what could be one of the more lucrative specialized psychedelic drug markets yet.
Awakn Life Sciences
Awakn Life Sciences Corp. (NEO: AWKN)(OTCQB: AWKNF), a biotechnology company researching, developing, and commercializing psychedelic therapeutics to treat addiction with a focus on AUD, says that treating alcoholism is a multi-billion-dollar industry that “lacks efficacy and innovation.”
The company has two AUD programs: ketamine-assisted therapy, and MDMA-assisted therapy. They recently secured funding from Innovate UK, the British government’s innovation agency, to identify the quickest and most cost-effective route to market in both the UK and the U.S. for their ketamine-assisted therapy for treating AUD.
Awakn’s lead clinical development program on the biotech research and development side of the business is proprietary ketamine-assisted therapy for alcohol use disorder. Awakn has a Phase IIb clinical trial already completed.
The focus on ketamine is because it’s an anesthetic, so it naturally dulls any sense of anxiety. And the ketamine experience is only 90 minutes long, unlike MDMA or LSD where treatments can go on for hours.
“What’s really important to notice is that people actually coming into our trial were sober 2 percent of the time,” co-founder and CEO of Awakn, Anthony Tennyson, told Psychedealia. “So they were sober seven days a year. And we got them to the equivalent of 320 days a year sobriety,” he said. “If you think of the positive impact on the liver, kidneys—everything, all bodily systems—that is significant.”
Awakn is treating people in three clinics that they own and operate with the therapeutic approach developed in their Phase IIb trial. “What we’re now doing is also out-licensing that to other people’s clinics to empower them to provide hope for individuals, families, and communities who are suffering with addiction, and for which the current treatments are just not working.”
What Awakn’s researchers are finding out about AUD and other types of addictions is that there are three levels to the human brain—a lower-level function, a mid-level function, and an upper-level function, Tennyson said.
Lower-level functions are learning memory and reward prediction. Mid-level functions are marked by attributions for the importance someone puts on previous experiences or predicted future experiences. Upper-level functions are the mind and the cognitive control in a balanced brain. “The analogy I use is that the upper-level functions as software, and lower and middle are where the hardware is in a balanced brain or a non-addicted brain. The software maintains control over the hardware. What happens with repeated exposure to addictive substances, and also what our team has discovered that applies to other addictive behaviors like gambling or pornography, is that the upper-level software loses control over this hardware.”
For example, with alcohol addiction, the site of a bar triggers the memory that has been learned about a predicted future reward in the opioid receptor in the alcoholic’s brain. Alcohol interacts with that triggering and gives the alcoholic pleasure.
Awakn uses psychedelics to disrupt the connections between those brain circuits and the operations within those circuits, to sort of “take those parts of the brain offline.” In the space that disruption provides, psychotherapy is used to enable people to forgive themselves, but also develop much more dynamic and better coping mechanisms to fight off and fight against the urges to relapse.
The Awakn treatment has a three-step protocol: a prep session, a ketamine session, and an integration session. “The prep session is about bringing the issues to the surface, such as what life experience, what trauma, what decisions did you go through for you to end up where you are today,” he said.
Memories are brought out by a qualified psychotherapist, then those memories are disrupted during the ketamine experience. “As they (the memories) are laid back down, they are laid back down in a fragmented way, and they become less impactful and potentially less triggering for you. Ketamine kicks the brain into a state of neurogenesis, so there are new neural connections forming.”
Awakn is also working with MDMA in conjunction with psychotherapy for addiction treatment. “MDMA switches off the fight-or-flight mechanism,” he said. “So if a childhood trauma or an adolescent trauma contributed to you being addicted, you can access those traumatic memories without the body clamming up and you walk out the door. It enables you to forgive yourself, to like yourself, but also most importantly, to potentially forgive whoever inflicted the trauma on you.”
So far, according to an article published in Addiction Biology journal, the data collected from various studies about AUD demonstrates that these psychedelics—ketamine, psilocybin, and MDMA, plus ayahuasca and mescaline—are in fact good candidates for treating excessive alcohol consumption and that it’s important to note that no study showed an increase in alcohol consumption as a consequence of psychedelic use. “This is contrary to the effect shown by other psychoactive substances such as nicotine, cocaine, amphetamine, cannabinoids, morphine, or caffeine, which have been shown to increase alcohol consumption,” the article added, concluding that data from these studies presented some “methodological concerns” that make it difficult to draw definitive conclusions, including lack of control over the administered dose.