Psychedelic Clinical Trials
Leading you Through the Psychedelic Clinical Research Journey
Altasciences is a pioneer in psychedelic drug evaluation, leading the way as the first early-phase CRO in North America to provide comprehensive solutions for this groundbreaking area of research. We aim to bring life-changing treatments to underserved populations by efficiently advancing therapies for complex, treatment-resistant conditions such as:
- Addiction
- Anxiety
- Major depressive disorder
- Post-traumatic stress disorder
- End-of-life care
- Alcohol use disorder
With years of expertise in this field, Altasciences is the ideal partner for your program—let our knowledge and experience be your asset.
Altasciences’ Excellence in Psychedelic Drug Development
Since the inception of this novel field of development, Altasciences has demonstrated focused commitment and expertise.
Our experience in psychedelic drug development includes:
- Completed preclinical IND-enabling programs for multiple molecules, resulting in successful filings and program advancement.
- Conducted a Thorough QT (TQT) study in healthy participants to assess cardiac impacts of psychedelics, ensuring calm and careful management for reliable data collection.
- Delivered a range of preclinical and clinical programs, both completed and ongoing, with more planned for the future.
Our ability to successfully conduct a TQT study with a psychedelic drug is a testimony to the skill of our teams, the excellence of our facilitation, and our careful attention to set and setting, including minimizing clinic activity inside the dedicated psychedelic drug development section of our clinics. Our experience, resources, and diligent commitment to the field ensure that we are the logical choice for your early-phase psychedelic drug development.
Turnkey Solution
- In-house scientific and regulatory guidance to assist you in navigating the complexities of this research within North America.
- Qualified, trained, and experienced medical professionals providing safety oversight and facilitation.
- Preclinical IND-enabling program experience with multiple molecules, resulting in successful filings and program advancement.
- Protocol design in accordance with regulatory guidelines.
- Bioanalytical capabilities to fully support program development from preclinical through Phase III patient trials, with full FDA Schedule I licensing in place.
- Clinical Conduct:
- Purpose-built clinical units accommodating all the specialized needs of psychedelic drugs.
- A comprehensive facilitation program supports participants throughout the process, enabling the efficient conduct of required first-in-human (FIH) and clinical pharmacology trials.
- Best-in-class timelines for first-in-human (FIH), Thorough QT (TQT), food-effect (FE), relative bioavailability (RelBA), and drug-drug interaction (DDI) enrollment, while supporting the unique safety and operational requirements of this drug class.
- Robust site network for trials requiring patients.
- In-house psychiatric and neuroscience team.
- Our expert pharmacodynamic teams develop measurement approaches to analyze subjective effects and generate a holistic, multi-dimensional data set that provides a thorough understanding of the compound’s effects. We also have the regulatory expertise to design, deliver, and analyze program results.
A Deeper Dive Into Our Psychedelic Clinical Trial Expertise
WATCH OUR WEBINAR—The Many Facets of Early Phase Evaluation of Psychedelics in Psychiatry
The following topics are covered:
- Regulatory requirements for developing a CNS-active drug and how they apply to psychedelic clinical trials
- Importance of abuse potential evaluation and the drug scheduling process
- Required preclinical and clinical studies and timelines
- Strategies for early data collection to inform abuse potential, safety, and proof of concept (efficacy)
- Intricacies of handling a Schedule I substance in drug trials
Speakers
Dr. Beatrice Setnik, Chief Scientific Officer at Altasciences
Beatrice has been working in clinical drug development and abuse potential assessment since 2005. She is the Chief Scientific Officer at Altasciences and an Adjunct Professor at the University of Toronto (Department of Pharmacology and Toxicology). Beatrice earned her doctorate degree in Pharmacology and the Collaborative Program in Neuroscience from the University of Toronto. She has published numerous research articles in internationally recognized peer-reviewed journals and is a recognized expert in the field of human abuse and physical dependence potential evaluation.
Dr. Sharon Cheetham, Director, In vivo Pharmacology at Sygnature Discovery
Sharon is a Director of In Vivo Pharmacology at Sygnature Discovery. She is a visiting Professor at the University of Nottingham, an external examiner at the University of Bath and a Fellow of the British Pharmacological Society. Sharon started her scientific career at the Institute of Psychiatry, University of London, working in the field of epilepsy with Professor Brian Meldrum. She went on to St George’s Hospital Medical School to study with Professor Roger Horton. Sharon transitioned from academia to industry by joining the CNS group at Boots Pharmaceuticals in 1988, which became BASF Pharma. In 2001, Sharon became a Director and co-founder of RenaSci Limited, which was acquired by Sygnature Discovery in 2018.
We have dedicated teams focused on psychedelic clinical trials, specializing in this unique and ever-evolving field of clinical research. Our unique offerings include:
Efficiency and Participant Access
- Extensive database of 400,000 healthy volunteers, including a robust number of recreational drug users, with a selection of appropriate populations for psychedelic studies
- Efficient recruitment of full panels of suitable participants
- Safe and comfortable environment to support participant care, retention, and compliance
Customized Facility – Set and Setting Specific to Psychedelic Studies
- Appropriate and flexible set and setting locations, with clinical trial units dedicated to psychedelic drug development
- Integrated preclinical to clinical POC, with Schedule I licenses
- Secure, locked facilities and compounding pharmacies
- Specialized procedures, including CSF sampling, imaging, EEGs, ECGs etc.
Safety and Study Integrity
- Monitoring oversight by a fully accredited facilitator, adaptable to different methodologies, as directed by the sponsor and specified in the study protocol Robust procedures for participant safety, including Safety and Security Officers on-site
- Adverse event monitoring to deliver all required regulatory data and ensure participant safety
- Mitigation strategies to address functional unblinding
- Protocol design and reviews by an experienced team with expertise in psychedelic drug development protocols and requirements
- Thorough understanding of the ever-evolving regulatory environment for psychedelic clinical trials, including 8-Factor Analyses (abuse potential evaluation)
Highly Experienced Staff and Facilitators
- Qualified and research-experienced facilitators for the conduct of psychedelic clinical studies; adaptable to different methodologies as dictated by each sponsor and based on their unique molecule
- Licensed Psychiatrist as Principal Investigator
- Clinical Neuropsychologist-coordinated training for pharmacodynamic assessments
- Regulatory and scientific experts to ensure regulatory compliance and robust study design
- Dedicated team for psychedelic research with a strong foundation in CNS/Neurological clinical research
Study Start-up—Rapid Recruitment for Psychedelic Clinical Trials
Our participant database of over 400,000 people allows us to rapidly recruit appropriate study populations for psychedelic clinical trials, including healthy volunteers and participants with prior psychedelic experience. We conduct additional screening to further exclude those who exhibit pre-session negative mood, anxiety, or depression, ensuring that your study is populated with suitable participants.
Complex Schedule I psychedelic clinical trials require careful planning and delivery, accounting for the need for facilitators and scheduling dedicated clinical space for study conduct, among other considerations that enable Altasciences to deliver the most comfortable experience for participants in these sensitive settings.
Plan with us, and we will ensure maximum efficiency in starting your psychedelic clinical trial right.
8-factor Analysis for Psychedelic Research
Altasciences’ extensive understanding and expertise in conducting 8-factor analyses help inform the necessary safety monitoring and assessment for psychedelic clinical trials.
Abuse/dependence potential evaluation is central to psychedelic research and a requirement for drug submissions in the United States and Canada. Safety monitoring must include a proactive approach to assessing and monitoring adverse events, including those that are abuse/dependence related.
Our team of scientific experts will guide you in ensuring that you meet regulatory requirements and report data that fully complies with regulatory standards and expectations, providing a solid foundation for later-phase research and drug approval.
What is Included in 8-Factor Analysis for Psychedelic Clinical Trials
A key part of drug scheduling is the 8-factor analysis process of the compound, required for U.S. drug approval and outlined in Section 201(c) [21 U.S.C. § 811(c)] of the Controlled Substances Act, which assesses its actual or relative potential for abuse based on the following factors:
- Its actual or relative potential for abuse.
- Scientific evidence of its pharmacological effect, if known.
- The state of current scientific knowledge regarding the drug or other substance.
- Its history and current pattern of abuse.
- The scope, duration, and significance of abuse.
- What, if any, risk there is to the public health.
- Its psychic or physiological dependence liability.
- Whether the substance is an immediate precursor of a substance already controlled under this subchapter.
Altasciences has vast expertise with 8-factor analysis for psychedelic clinical trials, including decades of human abuse potential testing, and a deep understanding of patterns of drug abuse generally, both from a scientific study and a human perspective.
Schedule I Licenses for Psychedelic Clinical Trials
For your psychedelic clinic trial, we have manufacturing, preclinical, and clinical facilities that meet the conditions for Schedule I licenses. As required by regulations, our facilities and their pharmacies are entirely secure and have locked storage capacity with limited, controlled access. Our rigorous standard operating procedures for safe handling, dispensing, shipment and receipt, and administration of controlled substances ensure smooth study conduct for compounds, including but not limited to psychedelics and hallucinogens like MDMA, DMT, psylocibin, ketamine, and ibogaine.
Related Resources
SCIENTIFIC JOURNAL
In this issue, we discuss the regulatory environment and challenges for Schedule I drug development, including the required preclinical and clinical studies, specialized clinical assessments, and important factors to consider in the formulation and manufacturing of these substances.
WEBINARS
Inside the Pharmacodynamic Toolbox
This webinar explores the flexible selection of pharmacodynamic measures to enhance the pharmacology, safety, and efficacy evaluation of CNS-active drugs, including psychedelics, in early-phase research.
A Square Peg in a Round Hole: Navigating Psychedelic Drug Development
This webinar examines key considerations for the clinical drug development of psychedelics, including how to evaluate a drug for abuse potential using an Eight Factor Analysis (8FA) and how best to optimize clinical trials with blinding, active control selection, and the role of facilitators.
Navigating the Yellow Brick Road
This webinar explores the design of early-phase psychedelic clinical trials, focusing on pharmacokinetic, pharmacodynamic, and safety evaluations before larger studies. It highlights efficient study conduct with healthy participants and discusses adaptations that ensure safety and scientific rigor in confined clinical settings.
WEBPAGES
FAQs
How does Altasciences ensure safety in Schedule I drug trials?
We have secure, segregated facilities for participants and locked pharmacies for the preparation of study drugs. We have expertly trained and experienced facilitators to act as lead and assistant monitors. The monitors play a critical role in providing volunteer support during their entire participation in these trials and nondirective psychological support during psychedelic dosing sessions. Our highly qualified clinical staff are skilled in medical monitoring and managing adverse events and negative effects.
The clinical trial unit is equipped with all standard safety monitoring equipment, providing a flexible configuration for conducting psychedelic studies.
What therapeutic areas are most suited for psychedelic drug development?
Some of the most promising areas for psychedelic clinical research include addiction, anxiety, major depressive disorder, post-traumatic stress disorder, end-of-life care, and alcohol use disorder.
How does patient recruitment for psychedelic studies differ from other clinical trials?
In a psychedelic clinical trial, it is important to ensure that participants are selected to meet inclusion/exclusion criteria and are appropriately selected to ensure safety and integrity. Depending on the study, healthy volunteer participants may be psychedelic naïve or experienced. Past recreational drug use history is carefully examined to determine any underlying substance use, psychological, or psychiatric disorders that are contraindicated by the protocol.
Additional inclusion and exclusion criteria include age, medical history, current medications, other mental health diagnoses, and use of recreational drugs. Clinical trial providers will independently verify your information with the patient’s physician(s) and will examine them, which includes blood tests and drug testing to ensure participant safety.
Which compounds are currently commonly used in psychedelic clinical trials?
Some of the more common compounds include psylocibin (a naturally occurring psychedelic compound found in certain species of mushrooms), psilocyn (the active metabolite of psylocibin), MDMA (3,4-methylenedioxymethamphetamine or commonly referred to as ecstasy), DMT (N, N-Dimethyltryptamine), ketamine (a dissociative anesthetic), and ibogaine (a psychoactive alkaloid found in plants of the Apocynaceae family, which can be extracted from these plants or semi-synthesized from the plant alkaloid voacangine).