This past spring, a multi-disciplinary team of researchers at the University of Iowa Department of Psychiatry guided their first human volunteer through a psychedelic session.
The team’s goal is to investigate psychedelic-assisted psychotherapy as a potential treatment for alcohol use disorder. The result of more than four years of careful planning and preparation, their ongoing psychedelics research positions the University of Iowa at the forefront of an emerging area of research.
“We’re one of only a few places in the Midwest doing this,” says Peg Nopoulos, MD, UI professor and chair of psychiatry within the Roy J. and Lucille A. Carver College of Medicine.
"As an academic medical center, we are proud to provide Iowans with an opportunity for treatment that they wouldn’t be able to get anywhere else. If we can show that this approach is beneficial, it has the potential to significantly expand treatment options for patients dealing with alcohol use disorder."
- Peg Nopoulos, MD
As the study’s principal investigator, Nopoulos believes the research she and her team are conducting has the potential to be revolutionary.
“As an academic medical center, we are proud to provide Iowans with an opportunity for treatment that they wouldn’t be able to get anywhere else,” she says. “If we can show that this approach is beneficial, it has the potential to significantly expand treatment options for patients dealing with alcohol use disorder.”
Psychedelic drugs may have potential as therapies
The term “psychedelics” refers to a broad category of hallucinogenic substances—such as Lysergic acid (LSD) and dimethyltryptamine (DMT)—that have uniquely transformative effects on the mind, perceptions, and moods of almost anyone who uses them. Psilocybin and ketamine are also psychedelics that have emerged as potentially useful treatments when combined with psychotherapy.
Although these drugs have been illegal in the United States since 1970, psychedelic medicine has experienced a renaissance in recent years as evidence has accumulated about the potential therapeutic benefits for certain neuropsychiatric conditions. Nopoulos is eager for Iowa researchers to play a leading role in determining how these substances might be used to help people safely and effectively.
“For us to better understand the potential, as well as the limitations and risks of these medicines, they must be studied in a rigorous scientific method,” she says. “We feel confident that our trial is designed in a manner that will address important questions that regulatory agencies, like the Food and Drug Administration, will need the answers to before these drugs can be approved for clinical use.”
Psilocybin is a psychedelic compound found in the psilocybe genus of fungi, also known as “magic mushrooms.” A growing body of research has shown psilocybin to be a highly effective and long-lasting treatment in a clinical environment for many conditions, from anxiety and depression to substance use disorder and post-traumatic stress disorder. One study found that 60-80% of cancer patients maintained a significantly reduced fear of death for nearly five years after receiving a single dose of psilocybin.
“Those are phenomenally promising results,” says Candida Maurer, PhD, the UI psychedelics team’s lead therapist.
Like psilocybin, ketamine has also been shown to have a positive impact on alcohol use disorder.
Rigorous clinical trial designed to investigate potential benefits of psychedelics
The UI trial will enroll individuals who have heavy alcohol consumption and who are interested in changing their drinking habits. Study participants will receive psychotherapy in combination with a single, randomized dose of either psilocybin or ketamine in a guided psychedelic session.
Randomized and controlled clinical trials are often designed to compare the drug of interest to a control substance, or placebo, such as saline and sugar that have no effect on users. The drawback of a placebo in the context of psychedelic clinical trials, is that study participants may realize they have been given the placebo when they do not experience any of the expected effects.
“Our study is one of the only ones designed to prevent this bias by comparing two drugs head-to-head: psilocybin and ketamine,” Nopoulos explains. “Each subject will indeed get a significant experience, and they will not know whether it was psilocybin or ketamine.”
The study is also “double-blind”: neither researchers nor participants will know (initially) which substance the participant has been dosed with. By comparing the two active drugs head-to-head, UI researchers hope to shed light on which is more effective at reducing long-term alcohol consumption and dependence.
The UI team’s ongoing research study is entitled “Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy (KAP) in the Treatment of Alcohol Use Disorder.”
Check if you're eligible for the study by visiting: https://redcap.link/PSIVSKET
After receiving one of the two substances in a guided session with the therapists, participants will then “integrate” their psychedelic experience in a series of follow-up psychotherapy sessions. Over the course of several weeks, the effects on participants will be measured through follow-up questionnaires and blood draws to evaluate the physical effects of drinking. In addition, subjects will undergo electroencephalograms (EEG) and brain MRI scans to study the effects of the therapy on the brain.
Once the main portion of the study is complete, participants will have the opportunity to experience a second guided psychedelic session in which they receive a dose opposite to the one they originally received. In other words, participants who originally received ketamine will be allowed to have an experience with psilocybin, and vice versa.
The UI psychedelics team is actively recruiting for this study.