Summary:
Neuroscientists at the University of California, San Francisco (UCSF) are launching CANOPY, a global observational study designed to monitor up to 3,000 individuals taking psychedelics in real-world environments. Led by Dr. Robin Carhart-Harris, the initiative moves beyond artificial laboratory settings to evaluate naturalistic use across homes, ceremonies, and retreats.
Backed by up to $8.5 million in total ARPA-H funding across three translational UCSF projects, CANOPY combines longitudinal remote psychological tracking with in-person neuroimaging, EEG, biomaterial sampling, and wearable biometric monitoring to determine how set, setting, and biology shape therapeutic versus adverse outcomes.
Key Facts:
- Real-World Observational Scope: CANOPY will track up to 3,000 adults worldwide who are already planning to take psychedelics in naturalistic settings (homes, retreats, clinics), following psychological and behavioral trajectories for up to six months post-experience.
- Federal ARPA-H Backing: The project is supported by the Advanced Research Projects Agency for Health (ARPA-H) as part of an $8.5 million multi-project initiative at UCSF, which also funds clinical trials exploring mindset/environment interactions and preclinical Alzheimer’s biomarkers in older adults.
- Deep Multimodal Phenotyping: A subset of participants will travel to UCSF for high-resolution fMRI brain scans, 64-channel EEG, salivary and blood biomarker sampling, and continuous wearable physiological tracking.
Source: UC San Francisco / ARPA-H
Over the past decade, the resurgence of psychedelic medicine has yielded promising clinical trial data for treatment-resistant depression, post-traumatic stress disorder, and substance use disorders. Yet, the vast majority of human psychedelic use takes place far beyond the sterile walls of university medical centers, unfolding instead in private residences, underground therapeutic circles, ceremonial retreats, and festival environments.
Because clinical trials enforce rigid inclusion criteria, standardized dosing, and artificial hospital-room aesthetics, they leave a critical scientific blind spot: how do variable naturalistic settings, individual biological baselines, and subjective intentions influence long-term mental health outcomes?
To bridge this gap between clinical efficacy and real-world effectiveness, neuroscientists at the University of California, San Francisco (UCSF) have initiated CANOPY, a large-scale global observational study.
Funded by the federal Advanced Research Projects Agency for Health (ARPA-H)—an agency within the U.S. Department of Health and Human Services tasked with driving high-impact biomedical breakthroughs—the study will follow up to 3,000 people across the globe to map what psychedelics do to human brains, bodies, and long-term well-being.
Bringing Scientific Rigor to Naturalistic Use
CANOPY is led by Dr. Robin Carhart-Harris, PhD, the Ralph Metzner Distinguished Professor of Neurology and Psychiatry at UCSF and a pioneering figure in human psychedelic neuroimaging.
Unlike conventional clinical trials, the researchers do not supply, administer, or recommend any controlled substances. Instead, the study utilizes an observational, citizen-science design, enrolling individuals who have already made independent plans to consume psychedelic compounds.
The study encompasses a broad pharmacological spectrum, tracking users of classical 5-HT2A agonists (psilocybin, LSD, ayahuasca, mescaline), atypical entheogens (ibogaine), empathogens (MDMA), and dissociative anesthetics (ketamine).
“Psychedelics are widely used outside research labs, yet much of what we know about their effects comes from carefully controlled research settings,” said Carhart-Harris. “CANOPY gives us an opportunity to bring scientific rigor to these experiences at a scale we haven’t had before — to understand not just whether psychedelics can be beneficial, but for whom, under what circumstances, and why.”
Multi-Tiered Longitudinal and Biometric Tracking
The vast majority of participants will engage with the study remotely through decentralized digital platforms, completing validated psychological inventories before their planned session, during the immediate integration period, and longitudinally for up to six months afterward.
For participants able to travel to UCSF’s Neurosciences building in San Francisco, CANOPY incorporates deep biological phenotyping:
- Functional Neuroimaging & Electrophysiology: Participants undergo functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) before and after planned sessions to measure changes in functional connectivity, neural entropy, and resting-state network modularity.
- Biomarkers & Epigenetics: Collection of blood and saliva samples to track neurotrophic factors (such as BDNF), inflammatory cytokines, neuroendocrine cortisol levels, and epigenetic alterations.
- Continuous Wearable Biometrics: Deployment of wearable biosensors to continuously monitor heart rate variability (HRV), peripheral autonomic arousal, and sleep architecture before, during, and after ingestion.
By combining granular physiological telemetry with longitudinal psychological endpoints, the team aims to parse out why identical doses can trigger transformative emotional healing in one individual and acute psychological distress or enduring anxiety in another.
Part of an $8.5 Million ARPA-H Initiative
CANOPY represents one branch of a tri-part, $8.5 million psychedelic research initiative awarded to UCSF by ARPA-H.
The broader initiative includes two parallel clinical projects:
- Set and Setting Mechanics ($4 Million): Co-led by Carhart-Harris and Dr. Jennifer Mitchell, PhD, professor of neurology and psychiatry at UCSF, this trial systematically deconstructs how specific environmental cues, therapeutic framing, and participant mindset alter neural and psychological responses.
- Preclinical Alzheimer’s and Geriatric Well-Being ($3.1 Million): Co-led by Dr. Mitchell and Dr. Lorenzo Pasquini, PhD, assistant professor of neurology, this investigation evaluates the safety, efficacy, and neuroplastic benefits of psychedelic interventions in older adults exhibiting subjective cognitive decline, low emotional well-being, and verified plasma biomarkers of preclinical Alzheimer’s disease.
Informing Future Policy and Harm Reduction
As state, federal, and international jurisdictions reconsider the legal and therapeutic status of entheogens, real-world epidemiological safety data is urgently needed.
By analyzing the complex interactions among pharmacology, psychological vulnerability, social support, and somatic health across thousands of diverse naturalistic sessions, CANOPY will establish an open evidentiary baseline. The findings will assist clinicians in refining patient stratification criteria, guide harm-reduction protocols for non-clinical users, and direct the development of next-generation psychiatric trials.
Questions and Answers
What is the primary goal of UCSF’s CANOPY study?
CANOPY is an observational study tracking up to 3,000 adults worldwide who are already planning to take psychedelics in real-world settings (such as homes, retreats, or private ceremonies). The goal is to understand how these substances alter the brain, body, and long-term mental health outside of artificial laboratory environments.
Do UCSF researchers provide participants with psychedelics?
No. Researchers do not provide, prescribe, or encourage the acquisition of psychedelics. CANOPY is an observational, non-interventional trial enrolling people who have already scheduled their own personal sessions. The core study is conducted remotely via digital assessments.
What biological measurements are being collected?
In addition to remote surveys tracking mood and well-being for six months, a subset of participants visiting UCSF will undergo structural and functional MRI, EEG recordings, blood and saliva biomarker analysis, and continuous biometric monitoring using wearable health sensors.
Editorial Notes:
- This article was edited by a Neuroscience News editor.
- Journal paper will be reviewed in full upon release.
- Additional context added by our staff.
About this psychopharmacology Research:
- Media Contact: Victoria Colliver
- Source: UCSF
- Image Credit: Image credited to Neuroscience News
