Clinical trials for psilocybin and other research in cancer
Learn about the foundational clinical trials and newer research exploring the power of psilocybin for cancer patients.
Sachi's take After a long “dark period,” clinical trials are back underway, investigating psychedelics and their potential for patients with cancer. At Sachi, we believe the landmark studies from the early 2000s, the follow-on studies, and current trials will lead to eventual FDA approvals, so that PAT is available to anyone facing this disease, as a patient, survivor, or supporter. New trials start every year—we will update this page with the information as much as possible.The landmark studiesPsilocybin research resumed in the early 2000’s At Johns Hopkins University, Roland Griffiths, a Dr. Griffiths, a highly respected psychopharmacologist who was not previously associated with the psychedelic movement, received permission to research the effects of psilocybin in healthy individuals. This research, which began in the early 2000s, effectively broke a 30-year research drought on psychedelics. Griffiths’ study was one of the first modern scientific investigations into the potential benefits of psychedelics in a controlled setting. For example, this was the first study to use a double-blind format, which was not common in the 1960s and 1970s. Healthy individuals were given either psilocybin or methylphenidate (Ritalin), a stimulant that could create a novel experience, making it a clever control. Despite this active placebo, the results for psilocybin were still statistically significant. This rigorous design set a new standard for modern psychedelic research. The study was published in 2006 and is sometimes referred to as the “mystical experience study.” The complete publication can be found here. Further studies continued follow-up with the same patients, with results that reinforced the important impact of psilocybin on their lives in a follow-up publication in 2008.“2/3 of trial participants reported it as one of the most spiritually significant experiences of their lives.”Mystical-type experiences occasioned by psilocybin mediate the attribution of personal meaning and spiritual significance 14 months later

Psilocybin research FOCUSED ON CANCER in the early 2000’s The first FDA-approved study for psilocybin with advanced-stage cancer patients was granted to Dr. Charles Grob at UCLA. This was a pilot study limited to 12 patients, to test the safety and feasibility of psilocybin. Participants received a smaller dose than previous studies (0.2 mg/kg patient weight), and the control received a non-psychoactive compound (niacin). This phase 1 study was a pioneering step in the use of psychedelic-assisted therapy to treat the psychological distress of patients with late-stage cancer.“Although past researchers reported more pronounced therapeutic effects with a higher-dose model, even the lower dose of psilocybin used in the current study gave some indication of therapeutic benefit in quantitative psychological evaluations.”Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer

Landmark Trials involving psychedelics in cancer: 2010’s breakthroughs Two separate trials conducted by Johns Hopkins University and NYU Langone Health, published in 2016, are widely recognized as the most important studies in the use of psilocybin for alleviating the psychological, emotional, and existential distress for cancer patients.Recruitment for the 2016 Johns Hopkins psilocybin study began around 2014, focusing on cancer patients experiencing significant anxiety or depression due to their diagnoses. The FDA-approved study upheld rigorous safety and ethical standards throughout the research. The study included 51 participants and was designed as a double-blind, randomized, placebo-controlled trial. Participants received either a high dose of psilocybin or a placebo (a small dose of psilocybin), with the sessions guided by trained facilitators to ensure safety and support.
  • About 80% of participants showed clinically significant decreases in depression and anxiety six months post-treatment, with around 60% achieving symptom remission.
  • About 80% of participants rated the experience to be among the top 5 most personally and spiritually significant of their lives.
Roland Griffith’s TED talk
An interesting feature of the Johns Hopkins study was the inclusion of community observers. These observers, who were part of the participants’ social circles, provided external assessments that complemented the self-reports and clinical evaluations conducted by the study staff. This multifaceted approach ensured a comprehensive understanding of the psilocybin’s effects on the moods, attitudes, and behaviors of study participants over time.The NYU Langone study, led by Dr. Stephen Ross, began recruitment at the same time. This study included 29 participants and followed a similar design with a double-blind, placebo-controlled approach. Participants were provided with psychotherapy sessions in conjunction with either psilocybin or an active placebo (niacin). The goal was to assess the efficacy of psilocybin in reducing anxiety and depression in cancer patients.
  • Approximately 60–80% of participants showed sustained improvement in anxiety and depression, with a similar range for symptom remission at the six-month mark.
Sachi's take These landmark studies set the groundwork and established the rigorous, peer-reviewed evidence needed to bring psychedelic-assisted therapy into the discussion for cancer patients. Both Johns Hopkins and NYU studies published in 2016 shared similar methodologies and objectives, but were conducted independently and without direct collaboration. With two powerful academic names producing similar data, the outcomes and results are powerful. The involvement of prestigious institutions, meticulous study designs, and the significant, lasting improvements reported by participants underscored the landmark nature of these trials and their profound impact on the field of psychedelic-assisted therapy.In addition to positive short-term effects for study participants, we are especially excited about their durability. Positive effects persisted for many months after the treatment, highlighting the potential of psilocybin to bring about lasting positive changes in mood, perspective, and emotional resilience. Note: to ensure consistency, most clinical trials in cancer use a synthesized version of psilocybin in their protocols. Patients in these trials are not eating normal “magic mushrooms.” Synthetic psilocybin is usually consumed in a capsule pill form with a specific milligram weight of the psilocybin ingredient, ensuring consistency of dosage. There are multiple versions of synthetic psilocybin, coming from groups like Usona, Filament Health, Compass, etc. It is assumed that natural psilocybin would have the same biological and biochemical effects as the synthetic version in these trials.
Recent studies exploring group therapy models Recent studies have extended previous research to investigate psilocybin and PAT to help cancer patients in group therapy sessions, reducing the number of therapists needed for the dosing session. These studies hope to prove that group PAT can provide the same, if not better, emotional and psychological relief as individual therapy, making the treatment more widely accessible and cost-efficient.In 2023, researchers from the University of Utah published results of one of these studies. The results showed significant reductions in depression and anxiety in patients with cancer, similar to previous studies, but now with the group format.
HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer Also 2023, using a similar group model, researchers at a community center in Maryland conducted a study that employed group therapy during the preparation and integration phases of psilocybin-assisted therapy. This approach also reduced the total number of therapy hours needed per participant while maintaining significant reductions in depression for people with advanced-stage cancer.Assessment of Psilocybin Therapy for Patients With Cancer and Major Depression Disorder Both studies demonstrated the potential for group-based PAT as an effective and resource-efficient model to treat psychological distress in cancer patients.
Sachi's take While the foundational, landmark studies showed the promise of psilocybin and PAT for cancer patients, recent studies are focused on cost and access. With the current shortage of psychiatric and psychological healthcare practitioners across the US, the potential for group sessions (through any or all stages of PAT) is important in order to ensure accessibility and affordability for all people facing cancer.
Current trials and research for psychedelics in cancer Researchers across the nation have started studies with larger participant groups and more diverse populations, including recruiting in locations such as Georgia, Nebraska, Texas, Utah, and Colorado. Some studies are focused on specific types of cancer (the Nebraska study is focused on pancreatobiliary cancer), while others are included in broader studies involving multiple academic research centers.The largest of these studies was launched by NYU Langone Health and The University of Colorado in collaboration with the National Cancer Institute (NCI). This study aims to enroll 200 to 300 cancer participants with symptoms of depression and anxiety from both New York and Colorado. Although the trial begins with a double-blind, placebo-controlled design, participants who do not achieve remission of symptoms in the initial phase may be given the opportunity to receive psilocybin (through a post-trial open-label phase). This means that even the control group who received a placebo will have the chance to receive the active psychedelic dosage treatment.Psilocybin-Assisted Psychotherapy for the Treatment of Psychiatric and Existential Distress in Patients with Advanced Cancer
Sachi's take The NCI coordinates the US National Cancer Program as part of the National Institute of Health (NIH). NCI’s support of the NYU Langone study further reinforces the validity and broad appeal for research into psilocybin and other psychedelics in the cancer space. The results of this study will hopefully result in even greater acceptance and adoption by the medical community.
Sachi's takeIn just over 20 years, the scientific community has amassed tremendous evidence supporting psilocybin and PAT for cancer patients. We are most encouraged by the following:Psychedelic-assisted therapy offers a potential new path for treatment for patients facing cancer. For those who may have tried traditional methods of therapy or psychiatric prescription drugs, PAT offers hope and a different approach for the mental battle with cancer. Each person’s journey through cancer is unique. However they choose to face this disease, psychedelics can be helpful for the mental and emotional issues that may arise. While most of the clinical trials have focused on patients with late stage cancer, we believe that PAT can help anyone: patient, survivor, or supporter, who is affected by a cancer diagnosis. The personal anecdotes from study participants are powerful—their testimonials consistently point to psilocybin helping them conquer fear, face cancer, and understanding how to live in the best way possible.
  • “I am not afraid of death”
  • “Choosing to live now”
  • “There is a natural flow of life—I am part of that flow”
  • “Death is a natural part of life, and it need not be feared”
  • “Less anxiety about my body and my sickness coming back”
  • “Connectedness and unity with the universe and cosmos”
  • “I was everything... I was all this—this was me”
Psilocybin helps patients get in touch with core beliefs and roadblocks.
  • “One therapeutic function of psilocybin may be to assist participants in achieving insight into the cause of their distress, which is supplemented by our supportive and integrative psychotherapy treatment model” (from the NYU follow-on study)
  • “My team and I hypothesize that psychedelic sessions might have an advantage over traditional prescription antidepressants for patients with cancer-related depression or anxiety because it may help them deal with their underlying trauma” (from the University of Connecticut study) 
PAT can give individuals a sense of community and shared experience. Anyone who has faced cancer has felt the sense of isolation and loneliness in the face of this disease. The integrative, post-dosing sessions can help create connectedness and community with people going through similar emotions and feelings. Some of the recent studies using group therapy have reported that the groups stay together for support and community long after the trial has ended.

Continue learning from Sachi

The PAT experience: What to expect
The primary protocols for research of psilocybin in cancer
MENTIONED STUDIES AND RESEARCH

John Hopkins Study published in 2016 in the Journal of Psychopharmacology
Great episode from the Found My Fitness podcast featuring Dr. Griffiths discussing his research (also available in various podcast formats)
For a great summary presentation about the numerous Johns Hopkins studies of psilocybin for cancer, you can hear from Dr. Roland Griffiths in his 2016 TED talk
You can read the results of the NYU Langone study published in 2016 in the Journal of Psychopharmacology
Watch a presentation from Dr. Jeffrey Guss about the NYU Langone study
You can also read the publication about long-term follow-up from study patients, published in 2020
The information on this site is for educational purposes only and is not intended as medical advice. Psychedelics may or may not be legal in your jurisdiction. Consult a lawyer if you have questions about the law, and consult your care team before making any decisions about your health. Legal notice.
Note: There are several psychedelics under investigation for treatment of the mental and emotional symptoms of cancer. While we focus almost exclusively on psilocybin, we will include breaking information from trusted sources about others (MDMA, Ketamine, etc.).