Abstract
Background:
When administered alongside monitoring and support, psilocybin has shown promise in the treatment of multiple psychiatric conditions. However, the contribution and nature of participant support in the context of psychedelic trials are much debated.
Aims:
We sought to further illustrate the structure and format of the monitoring and support used in Compass Pathfinder Ltd (Compass) trials, with particular focus on the administration sessions.
Methods:
Audio recording transcripts from a 12-week clinical trial evaluating the efficacy of 25 mg COMP360 psilocybin in 22 participants with post-traumatic stress disorder were analyzed to measure speech rates (words-per-minute (WPM)) for participants and support providers. A thematic analysis was also conducted on post-dosing participant interviews to offer further insight into how monitoring and support were experienced by participants.
Results:
Comparison of support provider/participant WPM distinguished the administration from the preparation and follow-up sessions. Speech by either party during the administration sessions was rare; on average, 78% of the time was filled with silence, compared to 25% to 30% in non-administration sessions. Three main themes emerged in the thematic analysis: (1) support was minimally enacted, yet experientially salient, (2) autonomy was promoted through the introspective psychedelic state and non-directive support, and (3) primary modes of support during altered states of consciousness included reassurance and validation.
Conclusions:
The relative absence of verbal interaction suggests that the monitoring and support used in Compass administration sessions can be differentiated from practice in many conventional psychotherapies, 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy trials, and psycholytic treatment paradigms with psychedelic drugs.
ClinicalTrials.gov Identifier:
NCT05312151 (https://clinicaltrials.gov/study/NCT05312151).
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Supplementary Material
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