Importance: Obsessive-Compulsive Disorder (OCD) has a 2% global prevalence, but only about 50% of patients respond to conventional treatment, underscoring the need for additional effective interventions. Objective: To assess the feasibility, safety, and preliminary evidence for efficacy of repeated psilocybin administration in OCD patients who had previously attempted psychotherapy or...
A number of proposals across different fields have suggested incorporating "independent" actors into the research process as a way to manage potential bias. For example, in response to allegations of bias in psychedelic science, some have suggested the idea of independent auditors for adverse events, as well as the incorporation of independent researchers into the research teams of psychedelic...
As classic psychedelics' therapeutic potential is studied and their popularity continues to rise, it is important to establish their relative risks and benefits. Previous surveys have tended to use convenience sampling on social media, select participants who have had either extremely positive or negative effects, and have not compared the risk/benefit profile of psychedelics to other...
Recent discussions about the methodological rigor of psychedelic clinical trials have focused on potential underreporting or misreporting of adverse events (AEs), with many calling for their systematic assessment to help mitigate these issues. In their recent paper, Palitsky et al. offer a comprehensive framework for the assessment of AEs in psychedelic-assisted therapies, with consideration of...
Randomized controlled trials (RCTs) are considered the gold standard for demonstrating the efficacy of a treatment or intervention; however, the RCT study design alone is insufficient to prevent all forms of bias. In this paper, we review conflicts of interest and other biases that pose challenges to the methodological rigor of psychedelic RCTs, and explore recommended bias mitigation measures....
Research has demonstrated both risks and benefits to using psychedelics as a therapeutic intervention for a variety of mental health conditions. In recent years, the public discourse around psychedelic treatments has been largely positive and focused on benefits more than risks. We believe the field would benefit from more balanced attention to the risks as well as benefits of psychedelics...
Prolonged Grief Disorder (PGD) is distinct from yet related to non-pathologic grief, depression, addiction, and Post-Traumatic Stress Disorder (PTSD) with a prevalence of up to 10% in bereaved populations. Hallmarks of PGD include functional impairment a year or more post-bereavement and intense yearning for the deceased. Current treatments for PGD are typically psychological rather than...
Rationale: Psychedelic research re-emerged from a period of suppression into the so-called psychedelic renaissance. In parallel, most media reporting has shifted from the overstatement of the risks of psychedelics to overly positive hype. As the empirical evidence is more equivocal than frequently portrayed, the conclusions about the effectiveness of psychedelics should be considered...