The New England journal of medicine
November 3, 2022
Guy M. Goodwin, Scott T Aaronson, Oscar Alvarez et al.
1,095 citations
A single 25 mg dose of psilocybin, but not 10 mg, reduced depression scores more than a 1 mg control dose over three weeks in adults with treatment-resistant depression. In this phase 2 trial, 233 participants were randomly assigned to 25 mg, 10 mg, or 1 mg of synthetic psilocybin with psychological support. The 25 mg group showed an average 12-point drop on the MADRS depression scale versus a 5.4-point drop in the 1 mg group, a significant difference. The 10 mg group did not differ significantly from control. Response and remission rates at three weeks supported the primary result, but sustained response at 12 weeks was not significantly different.
Nature Medicine
October 1, 2023
Jennifer Mitchell, Marcela Ot’alora G., Bessel Van der Kolk et al.
400 citations
In a phase 3 trial, MDMA-assisted therapy reduced PTSD symptoms and functional impairment more than placebo with therapy in 104 participants with moderate to severe PTSD. The average decrease in PTSD symptom severity was 23.7 points with MDMA-assisted therapy versus 14.8 points with placebo, and functional disability improved by 3.3 versus 2.1 points. Participants were ethnoracially diverse, with 27% identifying as Hispanic/Latino and 34% as other than White. Severe side effects occurred in 9.4% of the MDMA group and 3.9% of the placebo group; no deaths or serious adverse events were reported. The treatment was generally well tolerated.
Frontiers in Pharmacology
February 21, 2018
Elizabeth M. Nielson, Darrick G. May, Alyssa A. Forcehimes et al.
111 citations
In an open-label pilot study of psilocybin-assisted treatment for alcohol dependence, researchers analyzed 17 debriefing sessions conducted the day after psilocybin medication sessions. Participants described key phenomena related to changes in their drinking behavior and the acute subjective effects of psilocybin. The findings illuminate change processes in patients' own words during clinical sessions, shedding light on potential therapeutic mechanisms and how participants express the effects of psilocybin. This study is unique in analyzing actual clinical sessions rather than interviews conducted separately from treatment.
Journal of Psychedelic Studies
October 5, 2018
Elizabeth M. Nielson, Jeffrey Guss
104 citations
Clinical research on psychedelic-assisted psychotherapy is advancing in the USA, with psilocybin and MDMA in FDA-approved trials. In the 1950s and 1960s, researchers' and clinicians' personal use of psychedelics was considered a potential confound, contributing to a 20-year research hiatus. Currently, no empirical research exists on personal use by current academic researchers and clinicians; its influence is undocumented and undertheorized. This paper explores the history of personal use, its potential impact on therapy and research, and argues that training for psychedelic-assisted therapy cannot fit neatly into modern psychopharmacology or psychotherapy frameworks. It contends that scientific exploration of therapists' firsthand psychedelic experience on therapy outcomes is feasible, timely, and necessary.
Frontiers in Psychiatry
February 3, 2021
Sara Tai, Elizabeth M. Nielson, Molly Lennard-Jones et al.
87 citations
A therapist training program for psilocybin therapy, developed for a phase IIb international, multicenter, randomized controlled study of treatment-resistant depression, is described. The manualized approach, based on evidence-based psychotherapeutic methods and approved by the FDA, includes online learning, in-person training, applied clinical training, and ongoing mentoring. After training 65 health care professionals across the US, Canada, and Europe, feedback indicated that didactic and experiential learning helped build conceptual understanding and skills. Clinical training and participant care under experienced therapists were most beneficial and challenging. Rigorous, scalable training requires collaboration among public, academic, and industry partners.
Psychology of Addictive Behaviors
June 5, 2023
Gabrielle Agin-Liebes, Elizabeth M. Nielson, Michael Zingman et al.
42 citations
In a small qualitative study of the first randomized controlled trial of psilocybin-assisted psychotherapy for alcohol use disorder, participants reported that the treatment helped them process emotions tied to painful past events, fostered self-compassion, self-awareness, and feelings of interconnectedness. The acute drug sessions laid the groundwork for more self-compassionate regulation of negative affect. Participants also described newfound belonging and improved relationship quality. The findings suggest psilocybin increases the malleability of self-related processing, reduces shame and self-critical thoughts, improves affect regulation, and lowers alcohol cravings, indicating that integrating self-compassion training with psychedelic therapy may enhance AUD treatment outcomes.
JAMA Network Open
June 3, 2024
Amy L. Mcguire, I Glenn Cohen, Dominic Sisti et al.
41 citations
A consensus statement from a 2023 meeting of 27 experts identifies 20 points of consensus across five ethical issues for integrating psychedelic medicines into mainstream medical practice: reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping. The meeting included clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists. The statement focuses on government-approved medical use in the US and abroad, emphasizing that policymakers must address challenges ahead while acknowledging the hopeful moment.
Journal of Humanistic Psychology
June 23, 2021
Elizabeth M. Nielson
26 citations
As psychedelic-assisted therapy with psilocybin expands, hundreds of therapists need training, yet current programs do not include a personal psilocybin experience. The last such training with a similar compound occurred in the Spring Grove LSD Training Study (1969–1974). This article examines archival data from that study to guide modern training efforts, suggesting that incorporating nonordinary states of consciousness may benefit therapist preparation.
Journal of psychopharmacology (Oxford, England)
June 10, 2025
Torsten Passie, Anja Loizaga-Velder, Alicia Danforth et al.
4 citations
A consensus-based model curriculum for education and training in substance-assisted psychotherapy (SAP) covers theoretical topics and practical components including apprenticeship observation, ongoing clinical supervision, and self-experience for trainees. The model, developed by authors with extensive SAP experience, also addresses peer and conventional supervision, respect for intercultural differences, and teachings about indigenous use of related substances. It is largely adapted to western industrialized countries with established graduate-level psychotherapy training. The curriculum may be valuable for psychedelic researchers, those training therapists for research studies, and those preparing for clinical work outside research settings.
Curr Top Behav Neurosci
December 10, 2024
Xiaojue Hu, Ingmar Gorman, Elizabeth M. Nielson
3 citations
Psychedelic Harm Reduction and Integration (PHRI) is a clinical model that combines principles from harm reduction, psychedelic-assisted therapy, mindfulness, and psychodynamic therapy to help clients prepare for and integrate psychedelic experiences without directly administering psychedelics. It uses non-pathologizing, client-empowering strategies, emphasizing non-directive and inner-directed approaches, somatic awareness, and psychological flexibility. The model addresses common integration challenges such as fear, ego dissolution, and increased emotional sensitivity, aiming to translate psychedelic experiences into lasting positive changes while reducing potential harms. The chapter outlines PHRI's theoretical foundations, distinguishes it from other approaches, and explores its clinical application, focusing on the integration phase.
Frontiers in Psychology
March 15, 2021
Ingmar Gorman, Ingmar Gorman, Ingmar Gorman et al.
Psychedelic Harm Reduction and Integration (PHRI) is a clinical approach for mental health providers working with patients who use or consider using psychedelics in any setting. It combines harm reduction psychotherapy and psychedelic-assisted psychotherapy, applicable in brief or ongoing therapy. PHRI shifts from focusing only on negative outcomes and abstinence-based addiction treatment toward compassionate, destigmatizing acceptance of patients' choices. The approach addresses assessment, preparation, and managing difficult experiences, responding to increased psychedelic research, media attention, and legal changes.
Frontiers in Psychology
March 15, 2021
Ingmar Gorman, Ingmar Gorman, Ingmar Gorman et al.
Psychedelic Harm Reduction and Integration (PHRI) is a clinical approach for mental health providers working with patients who use or consider using psychedelics in any setting. It combines harm reduction psychotherapy and psychedelic-assisted psychotherapy, applicable in brief or ongoing therapy. PHRI shifts from focusing only on negative outcomes and abstinence-based addiction treatment toward compassionate, destigmatizing acceptance of patients' choices. The approach addresses assessment, preparation, and managing difficult experiences, responding to increased psychedelic research, media attention, and legal changes.
Frontiers in Psychology
March 15, 2021
Ingmar Gorman, Ingmar Gorman, Ingmar Gorman et al.
Psychedelic Harm Reduction and Integration (PHRI) is a clinical approach for mental health providers working with patients who use or consider using psychedelics in any setting. It combines harm reduction psychotherapy and psychedelic-assisted psychotherapy, applicable in brief or ongoing therapy. PHRI shifts from focusing only on negative outcomes and abstinence-based addiction treatment toward compassionate, destigmatizing acceptance of patients' choices. The approach addresses assessment, preparation, and managing difficult experiences, responding to increased psychedelic research, media attention, and legal changes.