Commentary: A framework for assessment of adverse events in psychedelic research DOI Creative Commons
Katherine Cheung, Rebecca Ehrenkranz, Jared T. Hinkle

et al.

Journal of Psychopharmacology, Journal Year: 2024, Volume and Issue: unknown

Published: Dec. 29, 2024

Recent discussions about the methodological rigor of psychedelic clinical trials have focused on potential underreporting or misreporting adverse events (AEs), with many calling for their systematic assessment to help mitigate these issues. In recent paper, Palitsky et al. offer a comprehensive framework AEs in psychedelic-assisted therapies, consideration spiritual, existential, religious, and theological impacts that psychedelics can have. this commentary, we respond al.’s proposal, discussing framework, its feasibility, various methods. We emphasize need ensure AE is held same standard as research other areas, addition maintaining improving transparency accessibility reporting.

Language: Английский

Emerging Medications for Treatment-Resistant Depression: A Review with Perspective on Mechanisms and Challenges DOI Creative Commons
Michael J. Lucido, Boadie W. Dunlop

Brain Sciences, Journal Year: 2025, Volume and Issue: 15(2), P. 161 - 161

Published: Feb. 6, 2025

Background/Objectives: Non-response to initial treatment options for major depressive disorder (MDD) is a common clinical challenge with profound deleterious impacts affected patients. Few treatments have received regulatory approval treatment-resistant depression (TRD). Methods: A systematic search of United States and European Union trials registries was conducted identify Phase II, III, or IV trials, last update posted on after 1 January 2020, that were evaluating medications TRD. For both the US EU registries, condition term "treatment resistant depression" associated lower-level terms (per registry protocol) used. registry, secondary using "depressive disorders" modifying "inadequate" also performed capture registrations not tagged as Two additional searches in "suicide" "anhedonia" transdiagnostic targets investigational medications. Trials categorized based primary mechanism action trial's medication. Results: Fifty TRD, 20 anhedonia, 25 suicide identified. Glutamate system modulation currently most compounds development, including antagonists allosteric modulators NMDA receptors, AMPA metabotropic type 2/3 glutamate intracellular effector molecules downstream signaling. Psychedelics seen greatest surge among mechanistic past 5 years, however, psilocybin particular garnering significant attention. Other mechanisms included GABA modulators, monoamine anti-inflammatory/immune-modulating agents, an orexin 2 receptor antagonist. Conclusions: These investigations offer substantial promise more efficacious potentially personalized medication approaches Challenges detecting efficacy TRD include heterogeneity within population stemming from presumed variety biological dysfunctions underlying disorder, comorbid disorders, chronic psychosocial stressors, enduring effects prior serotonergic antidepressant treatments.

Language: Английский

Citations

3
Psychedelic‐assisted treatment for substance use disorder: A narrative systematic review DOI Creative Commons

Theodore Piper,

Francesca Small,

Sam P. Brown

et al.

Addiction, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 30, 2025

Abstract Background and aims This is the first systematic review of extant literature on all major psychedelic‐assisted treatment for alcohol use disorder (AUD), tobacco (TUD) other substance disorders (SUD). We aimed to summarise evidence efficacy AUD, TUD, SUD; evaluate its quality; offer recommendations research. Methods was a prospectively registered narrative open‐label, randomised controlled trials (RCT), observational studies d‐lysergic acid diethylamide (LSD), mescaline, psilocybin, ayahuasca, ketamine, ibogaine 3,4‐methylenedioxymethamphetamine (MDMA). Eligible had SUD outcome measures including craving, use, relapse, remission. Study quality evaluated using Cochrane Collaboration Risk Bias (RoB), RoB in Non‐randomised Studies Interventions tool. Certainty RCTs judged Grading Recommendations, Assessment, Development, Evaluations (GRADE) Findings 37 (2035 participants) were reviewed: LSD (14; n = 1047); mescaline (1; 7); psilocybin (4; 135); ayahuasca (3; 101); ketamine (10; 579); (5; 166); MDMA 14). There no serious adverse events reported any study. A two‐centre, placebo‐controlled, phase 2 superiority RCT double‐blind, four‐arm, placebo‐controlled AUD yielded best efficacy. Progression support 3 secured from an open‐label study TUD nine cannabis disorder, cocaine opioid (all with high‐RoB low‐GRADE certainty). Conclusions Psilocybin‐assisted appears have among treatments alcohol, tobacco, disorders. Future research should report safety events; screen person‐level characteristics indicating that contraindicated; strive mitigate blinding participants interventions; factorial designs drug psychotherapy trials; build consensus field‐specific Core Outcome Set.

Language: Английский

Citations

1
On Minimizing Risk and Harm in the Use of Psychedelics DOI Creative Commons

Jules Evans,

Marc Aixalà,

B. Anderson

et al.

Psychiatric Research and Clinical Practice, Journal Year: 2025, Volume and Issue: 7(1), P. 4 - 8

Published: Feb. 11, 2025

This article outlines recommendations from 30 psychedelic researchers on how to create a better safety net.

Language: Английский

Citations

1
Utilizing Psychedelics to Enhance Well-Being: A Systematic Review DOI Creative Commons
Samuel Thomson, Nikos Thomacos

Journal of Psychoactive Drugs, Journal Year: 2025, Volume and Issue: unknown, P. 1 - 17

Published: March 31, 2025

Psychedelic-assisted therapy is gaining recognition for its potential to enhance human functioning. While most research has focused on psychedelic' therapeutic use mental illness, this review applies the PERMA Theory of Well-Being systematically examine their role in enhancing well-being healthy individuals. The final search five academic databases was conducted February 4, 2024, including studies published from 1994. After applying inclusion criteria (controlled or naturalistic experimental design with an outcome measurement at least 7 days post-consumption), 19 were included. Encompassing 949 participants, two involved 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), seven ayahuasca, lysergic acid diethylamide (LSD), and eight psilocybin. Results consistently indicate psychedelic consumption related enduring enhancements PERMA's elements well-being, positive emotions, engagement, relationships, meaning, accomplishment. discussion adverse effects frequently absent, no serious reported six studies. Future should address limitations included by conducting larger-scale, longitudinal randomized controlled trials that incorporate a comprehensive assessment well-being. Nevertheless, findings systematic call paradigm shift, moving beyond disease-focused lens recognizing psychedelics' capacity individuals, ultimately fostering flourishing.

Language: Английский

Citations

1
Excusing Psychedelics and Accommodating Psychedelics DOI Creative Commons
Edward Jacobs

The American Journal of Bioethics, Journal Year: 2025, Volume and Issue: 25(1), P. 107 - 109

Published: Jan. 2, 2025

Language: Английский

Citations

0
Associations between psychedelic-related and meditation-related variables: a longitudinal study DOI
Otto Simonsson, Sankalp Chaturvedi,

Peter S. Hendricks

et al.

Journal of Psychiatric Research, Journal Year: 2025, Volume and Issue: unknown

Published: March 1, 2025

Language: Английский

Citations

0
Exploring the potential of psychedelic-assisted psychotherapy for moral injury: A scoping review DOI

Viktoriia Kurkova,

Olga Winkler, Andrew J. Greenshaw

et al.

Progress in Neuro-Psychopharmacology and Biological Psychiatry, Journal Year: 2025, Volume and Issue: unknown, P. 111333 - 111333

Published: March 1, 2025

Language: Английский

Citations

0
Enhanced independence: De-biasing processes in psychedelic research and beyond DOI Creative Commons
Katherine Cheung, Rebecca Ehrenkranz, David B. Yaden

et al.

Research Ethics, Journal Year: 2025, Volume and Issue: unknown

Published: April 2, 2025

Randomized controlled trials (RCTs) are considered the gold standard for demonstrating efficacy of a treatment or intervention; however, RCT study design alone is insufficient to prevent all forms bias. In this paper, we review conflicts interest and other biases that pose challenges methodological rigor psychedelic RCTs, explore recommended bias mitigation measures. We focus on special relevance RCTs methods mitigating believe actionable urgent practices implement in research: (1) independent data assessment, (2) multisite trials, (3) quantitative analysis, (4) open science practices. Although advocate adoption these research, they not specific. suggest posed by research offer an opportunity researchers creatively find solutions across lifecycle reduce fields clinical research.

Language: Английский

Citations

0
What motivates spiritual health practitioners in psychedelic-assisted therapy? A qualitative study and implications for facilitator training practices DOI

Ishan Pasricha,

Caroline Peacock, Roman Palitsky

et al.

Psychedelics., Journal Year: 2025, Volume and Issue: unknown, P. 1 - 9

Published: April 29, 2025

Spiritual health practitioners (SHPs), also known as healthcare chaplains, are increasingly involved in facilitating psychedelic-assisted therapies clinical trials and community settings. Although the motivations of therapeutic to impact decision-making treatment outcomes, little research has investigated what drives SHPs pursue this work. This qualitative study examined n = 15 SHP's (60% female; M Age 46.57) who were legal administration therapy. An inductive-deductive analysis approach yielded two major themes: (1) Initial Motivation for Practicing PAT, (2) Ongoing Sources Meaning Fulfillment. The often cited personal experiences key entering field, frequently linked a significant encounter with psychedelic use. most common Fulfillment included witnessing healing others experiencing positive impacts from care. article addresses substantial role that appear play SHPs’ area practice. Such provide valuable first-hand knowledge unique phenomenology treatment, although they can potentially introduce biases reduce objectivity. Training certification guidelines set by Association Clinical Pastoral Education (ACPE) may help address these risks through heavy emphasis placed on self-literacy reflective learning components. Guided findings, we novel exercise, well several existing ACPE components support facilitators facilitators-in-training any professional background.

Language: Английский

Citations

0
Psychedelic-assisted psychotherapy: The need to monitor adverse events DOI

KRJ Schruers,

Nicole Leibold

Journal of Psychopharmacology, Journal Year: 2025, Volume and Issue: unknown

Published: May 21, 2025

The therapeutic use of psychedelics for mental health issues holds considerable promise. However, systematic assessment adverse events associated with these substances has received relatively little attention. Here, we discuss several considerations concerning the in psychedelic-assisted therapies. We preference using term “adverse effects” over “side effects”, as well ongoing debate regarding which are classified psychedelic. also provide recommendations on when and how to assess effects, example importance study them any kind therapy involving psychedelics, comprehensive monitoring a wide range physical parameters combination behavioral outcomes individual’s experience, at baseline throughout study. Also, sex-specific differences should be considered. Furthermore, highlight significant studies that have addressed aspects. In summary, offer great promise potential treatment (add-on) option psychiatry, but more rigorous effects is needed promote safe implementation clinical practice.

Language: Английский

Citations

0