Psychedelic Breakthroughs: Key Considerations for Clinical Trials



1. FDA Approval for IND Application

The clinical trial process requires adherence to complex DEA and FDA regulatory frameworks including registrations, licenses, inspections, and state and local laws. The  Center for Drug Evaluation and Research’s Manual of Policies and Procedures mandates preliminary preclinical data collection to confirm the product is reasonably safe for initial testing in humans. Following preclinical studies, submission of an IND application that provides detailed protocols for proposed clinical studies is required. After submission of the IND application, researchers must comply with a mandatory 30-day waiting period before beginning human clinical trials to give the FDA a chance to review the IND submission.

2. DEA Registration

In addition to FDA approval, researchers who conduct clinical trials with Schedule I drugs must register with the DEA. Receiving a Schedule I controlled substance for research requires a DEA Form 222. The DEA has established a dedicated web portal to submit applications for research on Schedule I substances.

3. Site Selection

When selecting a site for a clinical trial, there are several key factors that must be evaluated. First, the site’s Quality Management System should be scrutinized along with key Standard Operating Procedures. Previous inspection history and findings are also crucial in determining the suitability of the site. Equally important is the site’s patient database; review of the database should focus on its relevance to the clinical trial indication subject to inclusion/exclusion criteria. The site’s recruitment history, study-specific metrics, and processes for initiating a new study — from site selection to contract finalization to the enrollment of the first participant — should also be evaluated.

4. Harnessing Digital Health Tech

Digital therapeutics can enhance clinical trials and streamline data collection. Working with vetted vendors and maintaining compliance with evolving digital health tech standards is imperative. Lawmakers are putting regulations in place to safeguard health data privacy. Selecting partners that have the necessary certifications is an important consideration as well as complying with the ever-changing rules around data security and maintaining data integrity.

5. Informed Consent: Ongoing and Essential

Respecting patient rights is central to any clinical trial. Essential to this is ensuring ongoing informed consent from participants. The principle of informed consent extends to the practice of therapeutic touch, a component particularly relevant to psychedelic-mediated therapy. Fully informed consent should be sought at intake and during therapy sessions, acknowledging the ongoing nature of the consent process.


The renewed interest and research into psychedelics and their potential to address severe health conditions and behaviors is stirring excitement. Societal reservations and stigma around psychedelic research seem to be changing as evidenced by the increase in federal funding for psychedelic research and the FDA’s June 2023 publication of draft guidance on conducting psychedelic clinical trials. Nevertheless, use of Schedule I psychedelics in clinical trials may face stricter inspection. Given the multitude of legal and regulatory layers to navigate, sponsors may want to seek professional guidance to ensure regulatory compliance and hassle-free dealings with regulatory bodies, thereby reducing the chance of a costly interruption or clinical site closure.

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Source JD Supra

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