Clinical Neuropsychopharmacology and Addiction
September 1, 2026
Beatrice Dal Bianco, Matteo Buonarroti, Alessandro Lo Jacono et al.
Background: Epidemiological data on psychedelic use in Italy is limited. In this study, Italian responders in the Global Psychedelic Survey 2025 were subanalyzed to describe patterns of use, motivations, subjective experiences, and health correlates. Methods: Adults (≥21 years) with lifetime psychedelic exposure, residing in or born in Italy or San Marino, were surveyed in a web-based,...
International Journal of Mental Health and Addiction
March 17, 2026
Haley Maria Dourron, Melissa Bradley, Heith Copes et al.
Abstract Despite a long-standing interest in the potential similarities between psychedelic and psychotic experiences, no recent research has systematically explored the subjective overlap between these states in individuals who have experienced both. To provide rich accounts of potential overlaps and distinctions, we conducted semi-structured interviews with 19 individuals diagnosed with...
Translational Psychiatry
February 14, 2026
Michael H Sutherland, Christopher R. Nicholas, Richard C Lennertz et al.
The serotonergic psychedelic psilocybin induces neural plasticity and profoundly alters consciousness. The benzodiazepine midazolam blunts neural plasticity and induces conscious sedation and amnesia at low doses. In our recent open label pilot study, we administered oral psilocybin (25 mg) along with intravenous midazolam at doses allowing a full psychedelic experience while blunting memory...
Front Psychiatry
December 9, 2025
Haley Maria Dourron, Heith Copes, Daniel H. Grossman et al.
3 citations
Background: People with a history of psychotic disorders are excluded from contemporary trials of psychedelic-assisted therapy. Although survey studies have explored the impact of naturalistic psychedelic use on people with a history of psychotic disorders, a qualitative study has yet to examine the subjective effects of psychedelic use in this population during both the acute effects and...
Drug and Alcohol Dependence
July 1, 2025
Dilara Bahceci, Krista J. Siefried, Maureen Steele et al.
Methamphetamine use disorder, associated with significant morbidity and mortality, has limited effective treatments. Psychedelic-assisted psychotherapy shows promise, but data on its safety and efficacy in this population are limited. This exploratory study describes the demographic, substance use, and mental health characteristics of people who used methamphetamine and psychedelics and the...
Psychedelic Medicine
January 20, 2025
Marianna Graziosi, Gabrielle Agin-Liebes, Mary P Cosimano et al.
9 citations
Introduction: Serotonergic psychedelics, serotonin 2A receptor agonists such as psilocybin that can result in substantially altered states of consciousness, are used in recreational and research settings. The safety of psychedelic experiences in research settings is supported by controlled physical environments, presence of clinical and medical staff to address emergent issues, screening for...
Nat Med
November 1, 2024
Jennifer Mitchell, Marcela Ot’alora G., Bessel Van der Kolk et al.
4 citations
In the version of the article initially published, some members of the MAPP2 Study Collaborator Group were listed only in the Supplementary Information. Charlotte Harrison, Berra Yazar-Klosinski, Wael Garas, Darrick May, Cole Marta, Susan Walker, Elizabeth Nielson, Gregory Wells, Randall Brown, Revital Amiaz, Yair Wallach, Ray Worthy, Alia Lilienstein and Amy Emerson have now been added to the...
Translational Psychiatry
September 12, 2024
Christopher R. Nicholas, Matthew I Banks, Richard C Lennertz et al.
10 citations
Aspects of the acute experience induced by the serotonergic psychedelic psilocybin predict symptomatic relief in multiple psychiatric disorders and improved well-being in healthy participants, but whether these therapeutic effects are immediate or are based on memories of the experience is unclear. To examine this, we co-administered psilocybin (25 mg) with the amnestic benzodiazepine midazolam...
Am J Psychiatry
2024
Kelley C. O’donnell, Brian T Anderson, Frederick S. Barrett et al.
31 citations
Misinterpretations and Omissions: A Critical Response to Goodwin and Colleagues' Commentary on Psilocybin-Assisted Therapy.
Am J Psychiatry
2024
Michael Alpert, Kelley C. O’donnell, Casey Paleos et al.
22 citations
Psychotherapy in Psychedelic Treatment: Safe, Evidence-Based, and Necessary.
Frontiers in Psychology
2024
Kelley C O'Donnell, Lauren Okano, Michael Alpert et al.
Results from multiple recent studies support further evaluation of 3,4-methylenedioxymethamphetamine (MDMA) in conjunction with psychotherapy (i.e., MDMA-Assisted Therapy) in the treatment of post-traumatic stress disorder (PTSD). In two Phase 3 trials, MDMA-Assisted Therapy comprised a short-term, intensive psychotherapy that included three sessions directly facilitated by MDMA (referred to as...
Psychedelic Medicine
December 1, 2023
Julia Malicki, Amelia Baltes, Christopher R. Nicholas et al.
7 citations
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...
Nature Medicine
October 1, 2023
Jennifer Mitchell, Marcela Ot’alora G., Bessel Van der Kolk et al.
400 citations
This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (primary endpoint) and...
JAMA
August 31, 2023
Charles L. Raison, Gerard Sanacora, Joshua Woolley et al.
493 citations
Importance Psilocybin shows promise as a treatment for major depressive disorder (MDD). Objective To evaluate the magnitude, timing, and durability of antidepressant effects and safety of a single dose of psilocybin in patients with MDD. Design, Setting, and Participants In this phase 2 trial conducted between December 2019 and June 2022 at 11 research sites in the US, participants were...
Focus (American Psychiatric Publishing)
July 1, 2023
Jennifer Mitchell, Michael P. Bogenschutz, Alia Lilienstein et al.
97 citations
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...
Frontiers in Psychiatry
March 14, 2023
Jonathan Brett, Elizabeth Knock, Paul Liknaitzky et al.
16 citations
Methamphetamine use disorder is a chronic relapsing condition associated with substantial mental, physical, and social harms and increasing rates of mortality. Contingency management and psychotherapy interventions are the mainstays of treatment but are modestly effective with high relapse rates, while pharmacological treatments have shown little to no efficacy. Psilocybin-assisted...
Drug and Alcohol Dependence
February 1, 2022
Christopher R. Nicholas, Julie B. Wang, Allison R. Coker et al.
67 citations
Background Post-traumatic stress disorder (PTSD) is commonly associated with alcohol and substance use disorders (ASUD). A randomized, placebo-controlled, phase 3 trial demonstrated the safety and efficacy of MDMA-assisted therapy (MDMA-AT) for the treatment of severe PTSD. This analysis explores patterns of alcohol and substance use in patients receiving MDMA-AT compared to placebo plus...
Nature Medicine
June 1, 2021
Jennifer Mitchell, Michael P. Bogenschutz, Alia Lilienstein et al.
965 citations
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...
Psychological Medicine
November 4, 2020
Simon B. Goldberg, Benjamin Shechet, Christopher R. Nicholas et al.
66 citations
Abstract Background Scientific interest in the therapeutic effects of classical psychedelics has increased in the past two decades. The psychological effects of these substances outside the period of acute intoxication have not been fully characterized. This study aimed to: (1) quantify the effects of psilocybin, ayahuasca, and lysergic acid diethylamide (LSD) on psychological outcomes in the...
Psychiatry Research
January 2, 2020
Simon B. Goldberg, Brian T. Pace, Christopher R. Nicholas et al.
234 citations
The current meta-analysis examined the effects of psilocybin in combination with behavioral interventions on anxiety and depression in samples with elevated symptoms. Across four studies (one uncontrolled; three randomized, placebo-controlled; N = 117), within-group pre-post and pre-follow-up effects on anxiety and depression were large (Hedges' gs=1.16 to 1.47) and statistically significant....
Journal of Psychopharmacology
June 27, 2018
Christopher R. Nicholas, Kelsey M. Henriquez, Michele Gassman et al.
85 citations
Aim: The aim of the current study was to investigate the relationship between escalating higher doses of psilocybin and the potential psilocybin occasioned positive subjective effects. Methods: Healthy participants ( n=12) were given three escalating doses of oral psilocybin (0.3 mg/kg; 0.45 mg/kg; 0.6 mg/kg) or (18.8–36.6 mg; 27.1–54.0 mg; 36.3–59.2 mg) a minimum of four weeks apart in a...
Clinical Pharmacokinetics
March 28, 2017
Randall Brown, Christopher R. Nicholas, Nicholas V. Cozzi et al.
189 citations
IntroductionPsilocybin is a psychedelic tryptamine that has shown promise in recent clinical trials for the treatment of depression and substance use disorders. This open-label study of the pharmacokinetics of psilocybin was performed to describe the pharmacokinetics and safety profile of psilocybin in sequential, escalating oral doses of 0.3, 0.45, and 0.6 mg/kg in 12 healthy...
Kelley C O'Donnell, Michael Alpert, Lauren Okano et al.
preprint
Results from multiple recent studies support the use of 3,4-methylenedioxymethamphetamine (MDMA) in conjunction with psychotherapy (i.e., MDMA-Assisted Therapy) in the treatment of post-traumatic stress disorder (PTSD). In two Phase 3 trials, MDMA-Assisted Therapy comprised a short-term, intensive psychotherapy that included three sessions directly facilitated by MDMA (referred to as...