Alcohol use disorder (AUD) is widespread and problematic in the United States, and current pharmacotherapy options have relatively modest effects. Therefore, novel interventions such as ketamine therapy have gained interest as potentially efficacious options, known to generate unique psychotherapeutic experiences. The present secondary analysis examines the acute subjective experiences-both...
For a new clinical trial testing a group retreat-based format of psilocybin-assisted therapy, our research team created an initial set of practice guidelines that aimed to describe facilitator use of touch in a way that is ethical, supportive, and minimizes harm. In our first three retreats, however, we had two unexpected experiences with touch that led us to iterate our initial guidelines into...
Introduction: Effective blinding is especially challenging in randomized controlled trials (RCTs) involving psychedelics due to the inherent alterations in consciousness that these compounds induce. In this systematic review and exploratory analysis, we aim at synthesizing the methodologies used in RCTs involving classic psychedelics and identify procedures that can help minimize unblinding and...
Psychedelic MedicineAhead of Print Psychedelic Research as a Career Path: A Roundtable Discussion with Early Career Researchers in the FieldModerators: Jacob S. Aday, Natasha L. Mason, Participants: Bo Jarrett Wood, Hannah M. Kramer, Cynthia E. Ortiz, M. Frances Vest, Caroline Sagrera, and C. J. HealyModerators: Jacob S. Aday*Address correspondence to: Jacob S. Aday, PhD, Department of...
Psilocybin, a classic hallucinogen, may eventually be approved by the United States Food and Drug Administration for treatment-resistant depression. However, we are aware of only one published national survey of American psychiatrists regarding their opinions about hallucinogens and hallucinogen-assisted therapy, conducted by our group in 2016. Here, we report a repeat survey, using virtually...
The Mystical Experience Questionnaire (MEQ-30) and Challenging Effects Questionnaire (CEQ) are two of the most widely used, validated instruments to probe subjective effects of psychedelic drugs. However, these assessments are lengthy and can be a burden to study participants or patients if administered during acute psychedelic effects, after resolution of psychedelic effects when participants...
MDMA-assisted therapy (MDMA-AT) is an emerging treatment modality, with recent phase 3 trials indicating its potential for regulatory approval. Central to this therapy is the role of touch, yet its empirical evaluation in MDMA-AT, and psychotherapy in general, remains limited. The use of touch in combination with MDMA raises concerns about power imbalances and ethical boundaries. This article...
Psychedelics such as psilocybin have been shown to have persistent antidepressant effects, but with considerable individual variability in optimal dosing. Intravenous (IV) dosing is rapid onset and quickly titrated, possibly preceded by an anxiolytic for patient comfort. We explored the viability of IV psilocin with and without preadministration of lorazepam for possible future inpatient...
Psychedelic MedicineFebruary 28, 2024Dana D. DiRenzo, Jamie Perin, Erika Darrah et al.4 citations
This preliminary study suggests that a transient increase in cytokine production ≤1-week postpsilocybin may be found, although not consistently across patient populations. More broadly, peripheral cytokine production is possibly altered by psilocybin administration. ClinicalTrials.gov Identifier: NCT01988311.
Balancing the need for effective treatments against the potential for serious adverse events in those undergoing psilocybin therapy with a family history of BD, we argue for caution in psychedelic clinical trials but not outright exclusion of these individuals. Our risk stratification tool allows for more nuanced inclusion and exclusion criteria.
Recent trials of psychedelic-assisted therapy have suggested potential efficacy for the treatment of many health conditions that disproportionately impact sexual and gender minority (SGM) people, including major depressive disorder and alcohol and tobacco use disorders. Despite these promising findings, the potential benefits of psychedelics for SGM people have been largely ignored. First, we...
The reemergence of psychedelic medicines as clinical treatments has generated considerable interest in both professional and popular arenas. Although evidence is promising for psychedelic-assisted therapy (PAT), there is much that is not yet known and needs to be researched so as to understand how to safely and effectively utilize PAT in clinical populations and to most effectively deploy PAT...
Introduction: The field of psychedelic research and therapy is growing at an unprecedented rate, as is the need for shared terminology to allow for coherent conversations about these medicines. However, proclaiming consensus definitions at the present time may be a premature closure, limiting the possibility of what psychedelics can teach about the mind and brain. Objective: Our goal in this...
Psychedelic-assisted therapy has gained significant attention in recent years. However, there is a lack of empirical clarity on the role of psychosocial interventions (PIs) in clinical trials of psychedelic treatment due in part to deficiencies in reporting practices found in the existing literature. These PI include non-drug support or interventions provided by psychotherapists or facilitators...
Coadministration of psilocybin and buprenorphine was safely tolerated and did not demonstrate contraindicating effects vis-à-vis effectiveness of buprenorphine or the subjective effects of psilocybin. Challenges in feasibility led to modifications in the sample population and eligibility criteria and strategies to improve accessibility, minimize burden, and enhance overall...
Background: In the wake of positive clinical trial outcomes of psychedelic-assisted psychotherapy for the treatment of various psychiatric disorders, there has been an influx of financial investment into psychedelic drug development from the pharmaceutical and biotech sectors. Psychedelics are now a multibillion dollar industry, with hundreds of companies that are seeking to commercialize...
The trial will provide preliminary data on the feasibility, safety, acceptability, and psychosocial effects of PA-CBT. Results will inform randomized clinical trials to test the effects of PA-CBT for patients with depression and other mental health conditions, as well as hypotheses concerning mediating mechanisms at the cognitive and affective levels. ClinicalTrials.gov ID: NCT05227612.
Autism spectrum disorder (ASD) encompasses a range of neurodevelopmental syndromes diagnostically characterized by deficits in social communication and social interaction and repetitive, inflexible patterns of behaviors, interests, and thoughts. ASD affects people worldwide, irrespective of race, ethnicity, or socio-economic status, with debilitating effects on employment and interpersonal...
Psychedelic-assisted therapy (PAT) has re-emerged as a promising intervention for addressing mental health conditions and existential concerns. Despite growing enthusiasm, PAT may be difficult to integrate into mainstream health systems. The rich sacramental traditions of psychedelics, their centering of the human experience, proposed substrates of action, context-dependent outcomes, and highly...
Mental health problems including depression, anxiety, suicide, and burnout are common among health care providers. Resilience and well-being are factors thought to protect against these incidents. Clinical trials and naturalistic studies of psychedelic compounds have shown decreases in depression, anxiety, and suicidality while suggesting improvements in well-being. This secondary analysis of a...
This analysis suggests the utility of exploring clinical applications of dissociatives that occur within the supportive contexts that are characteristic of psychedelic research and that prioritize the optimization of psychologically valuable drug experiences. This study was registered with ClinicalTrials.gov (NCT02033707).
Clinical trials support the promise of psychedelic-assisted therapy (PAT) and reveal potential mechanisms underlying efficacy. Out of necessity, initial studies of PAT have focused on feasibility and impact with special attention to acute responses to the molecules, but investigations of the psychotherapy components of PAT have lagged other work. Years of research on other forms of...
Background: Psilocybin and psychedelic-assisted therapy (PAT) have gained renewed interest due to recent findings that PAT can enhance therapeutic outcomes. In 2019, the U.S. Food & Drug Administration (FDA) approved breakthrough therapy status to psilocybin for the treatment of depression, but PAT has yet to be approved as a therapeutic treatment for mental health disorders. Should the FDA...