Pacific Neuroscience Institute Launches New Psychedelic-Assisted Clinical Trial
by Zara Jethani
Nature-themed visual experience and psilocybin therapy used for treatment of alcohol use disorder
SANTA MONICA, Calif., March 18, 2021— Pacific Neuroscience Institute (PNI) has launched its first psychedelic-assisted clinical trial and begun participant enrollment.
The Visual Healing® study is a collaboration among PNI, award-winning filmmaker Louie Schwartzberg, and the Usona Institute, and tests a strategy incorporating a nature-themed immersive video experience into psilocybin-assisted therapy for patients with alcohol use disorder.
Since the late 1990s there has been renewed interest in psychedelic-assisted therapies to treat mental health conditions including addiction, anxiety, depression and PTSD.
The Treatment & Research In Psychedelics (TRIP) program at Pacific Neuroscience Institute is exploring how altered states of consciousness elicited by psychedelics can be harnessed to change behavior and improve brain health. TRIP program director and addiction medicine specialist, Keith Heinzerling, MD, is the principal investigator of the study.
“Psilocybin-assisted therapy shows promise for treating alcohol use disorder, but early studies suggest that patients with alcohol problems may be less likely to achieve a mystical experience with a standard psilocybin dose,” said Dr. Heinzerling.
“Feeling more connected with nature is a common element of a psychedelic mystical experience. Our pilot study will test whether adding Louie’s beautiful nature-themed Visual Healing® videos to the start of the psychedelic session, during the so-called ascent as the medicine begins to take effect, may facilitate reaching a peak or mystical experience. Results of the study may help us refine interventions that optimize the impact of psilocybin without having to increase the dose and will increase our understanding of the potential beneficial role of nature-connectedness in psychedelic therapies.”
This phase 2 study assesses feasibility, safety and efficacy of incorporating Visual Healing®, to optimize set and setting in psilocybin-assisted therapy for alcohol use disorder. All participants will receive two doses of 25 mg psilocybin therapy separated by four weeks. The 20 participants will be randomized into two cohorts – a Visual Healing® cohort and a standard Set and Setting arm. Psilocybin, the active ingredient in magic mushrooms, is provided as capsules by Usona Institute and considered non-addictive.
The Importance of Set and Setting
“We know from multiple psilocybin-assisted therapy clinical trials that participants who achieve a mystical experience are more likely to have a long-term change in behavior, which is why the mindset of the patient and the setting of the journey is so critical to consider,” said Daniel Kelly, MD, PNI director and founder, and co-investigator of the study. “The novel Visual Healing® approach we are taking along with the pre-journey counseling aim to optimize set and setting and maximize the chance of a mystical experience to ultimately help participants stop drinking.”
Preparation sessions are followed 1-2 weeks later by a supervised 4–5-hour psilocybin journey in the peaceful setting of the PNI TRIP room, with follow-up integration sessions. These sessions are crucial, allowing participants to address and, hopefully, resolve longstanding alcohol use-related issues.
“We are thrilled to be launching this first psilocybin-assisted therapy clinical trial at PNI and have other trials in development for patients with depression and grief that we hope will start later this year,” said Dr. Kelly. “As we embark on this important work, we are grateful to our supporters, including the Annenberg Foundation, which provided us critical seed funding to create TRIP, and our collaborators Louie Schwartzberg and Usona Institute.”
About Dr. Keith Heinzerling
Dr. Keith Heinzerling practices internal medicine and is an addiction medicine specialist at the Pacific Brain Health Center, Pacific Neuroscience Institute. His clinical and research focuses are on the treatment of alcohol, drug and substance use problems, with anti-addiction medications. As director of the TRIP program, he is involved in the development of psychedelic-assisted therapies for those suffering with addiction, depression, anxiety, and PTSD.
About Dr. Daniel Kelly
Dr. Daniel Kelly, a board-certified neurosurgeon, is the Director and one of the founders of the Pacific Neuroscience Institute, Director of the Pacific Brain Tumor Center and Pacific Pituitary Disorders Center, and is Professor of Neurosurgery at Saint John’s Cancer Institute at Providence Saint John’s Health Center. Considered to be one of the top neurosurgeons in the US, he is a multiple recipient of the Patients’ Choice Award, and has been awarded the Southern California SuperDoctors distinction 15 years in a row.
About the Author
Zara is the marketing director at Pacific Neuroscience Institute. Her background is in molecular genetics research and healthcare marketing. In addition, she is a graphic designer with more than 20 years experience in the healthcare, education and entertainment industries.
Last updated: March 25th, 2021