Altered Stakes: identifying gaps in the psychedelic-assisted therapy research informed consent process

Nearly 60% of the US population experiencing posttraumatic stress disorder have not received a meaningful clinical response from traditional interventions (Akiki & Abdallah, 2018). Early research using psychedelics in tandem with psychotherapy may offer a more effective option (Feduccia et al., 2019) and has been shown to provide or contribute to long-term relief or remission from PTSD symptoms (in small samples). Funding for psychedelic-assisted therapy (PAT) clinical-trials has increased to nearly billions (Phelps et al., 2022) and while the research is propitious, it is far from complete. Concerns about safety and generalizability have begun to surface (Love, 2022), including recent allegations of abuse. Though abuse is an issue within all clinical practice, risk is amplified by the non-ordinary state of consciousness experienced in high-dose PAT trials. In the US, treatment models using mind-altering substances are shaped by FDA-approved clinical research trials, which in turn define ethical practices and standards of care. By examining how existing regulations recommend governance for the informed consent process and reviewing publicly available documents from PAT trials, I aim to: 1) illuminate how risk and accountability are currently communicated to PAT participants; and 2) suggest how existing research policy might be updated to make working with trauma patients under non-ordinary states of consciousness safer and more ethically robust.