Clinical trials of psychedelic drugs impose constraints that make it difficult to judge how effective they will be in treating people
Clearly, if the only data continue to come from clinical trials with such stringent exclusion criteria, we will not learn whether people with these conditions are as likely to respond to psychedelic treatment as other people, or whether they are more or less likely to suffer adverse effects. Moreover, some of the people in these groups are those in greatest need of innovative treatments.
Exclusion criteria are not the only problematic aspect of clinical trials of psychedelics, however. Another is the psychotherapeutic component of the treatment, which is currently variable, time-consuming and extensive. In the psilocybin trial mentioned above, two therapists were assigned to each participant in the trial, and held preparatory sessions, further sessions after the drug was administered, and a series of follow-up calls by phone or videoconference to ensure their welfare.
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