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Synergy in Action

Methodological Issues in Study Designs for Clinical Trials with Psychedelics Working Group

Chairs: Amir Inamdar, MBBS, DNB (Psych), MFPM; Joyce Tsai, PhD

Most Recent Activity: Working Group Meeting, 2024 Autumn Conference, 12-13 September 2024, San Diego, CA – View Summary

Working Group Session, 20th Annual Scientific Meeting, 21-23 February 2024, Washington DC – View Summary

INAUGURAL MEETING: 2023 Autumn Conference – includes joint day with ECNP– view slides, 5-7 October 2023, Barcelona, Spain

With the recent renaissance in psychedelic research, interest in this area is rapidly growing. Psychedelics induce non-ordinary states of consciousness, and this creates challenges when designing and executing clinical trials in such areas aschoice of control groups, blinding, patient expectation, and expectancy bias.  

Currently there is no consensus on the issues that are critical to good clinical trial methodology in this space. In addition to blinding and controls, questions concern choice of appropriate efficacy endpoints, study duration, assessment of long-term safety and durability of response, appropriate retreatment interval for maintaining response, how much or how often psychological support should be provided – if it is even necessary and if a “sham” support control is needed.

We intend to build on the discussions from the Unresolved Issues in Psychiatry Research session in the February 2023 ISCTM meeting.

Leading up to the conference in Barcelona, the Psychedelics working group will be working within subgroups to discuss the following methodological issues in clinical trials with psychedelics: 

    1. Identify strategies to address challenges associated with blinding, choice of controls, and expectancy bias
    2. Examine the adequacy of commonly used efficacy measures and identify needs for additional or alternative measures
    3. Identify challenges in the reporting of adverse events in psychedelic trials (expected effects vs. adverse effects) 
    4. Discuss duration of induction and maintenance treatment, number of treatments, how to assess durability of response, long-term safety, and long-term efficacy  

In addition, this group will be working in collaboration with the ECNP working group on psychedelics leading up to the Autumn Conference.
At the meeting in Barcelona, the subgroups will report back and present their recommendations.

If you would like to be a part of this working group, please email info@isctm.org.