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In this STARR Insider Session, Hailey Gilmore, MPH, Clinical Development Liaison at atai Life Sciences, Dr. Scott Fisher, Lead Facilitator at Segal Trials’ Center for Psychedelic Research, and Morgan Hecker, BA, Clinical Trials Manager at CenExel Georgia, shared practical guidance on integrating psychedelic research into clinical trial sites.

The field of psychedelic clinical research is experiencing remarkable growth, creating unprecedented opportunities for research sites. Despite common misconceptions, Gilmore emphasized that “we’re really at the beginning” of this field’s development. For sites interested in entering this space, investigator-initiated trials (IITs) offer a valuable entry point. “I’ve helped set up dozens of IIT sites while I was with Lykos and they do get chosen by sponsors afterwards,” she revealed.

Success in psychedelic research requires three critical elements: specialized staffing (including licensed facilitators and skilled coordinators), appropriate infrastructure (comfortable dosing rooms with homelike atmospheres and DEA-compliant storage), and relevant experience with Schedule I substances and psychiatric populations. “Your rockstar coordinator is the best asset you’re going to have,” Gilmore noted.

Dr. Fisher highlighted unique recruitment challenges, noting that while interest is high, screen failure rates can reach 40-80% because many candidates have already experimented with psychedelics, making them ineligible. Hecker shared innovative scheduling solutions using live spreadsheets and project management platforms to coordinate the complex, multi-hour appointments required for preparation sessions, dosing days, and integration sessions.

Webinar moderator Luke Kramer emphasized that while psychedelic studies involve unique dynamics, “it’s not more difficult than conducting an inpatient psychiatric study. If this area sparks your interest, it’s absolutely worth exploring.”