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.
JAMA psychiatry
July 1, 2023
Roman Palitsky, Deanna M Kaplan, Caroline Peacock et al.
86 citations
Spiritual, existential, religious, and theological components are important in psychedelic-assisted therapy, but they have not been systematically integrated into clinical practice. Research shows that spiritually integrated psychotherapies are effective and produce additional benefits on spiritually relevant outcomes, which are particularly relevant to psychedelic therapy. Established standards in spiritually integrated psychotherapy can be applied to psychedelic-assisted therapy. Integrating these topics is needed for culturally competent, evidence-based treatment aligned with high clinical standards, and neglecting them may undermine treatment success and increase risks for patients.
Journal of mood and anxiety disorders
December 1, 2023
Sierra Carter, Grace Packard, Callan Coghlan et al.
18 citations
Black Americans reported more positive views of psychedelic-assisted therapy than White Americans after receiving brief psychoeducation about MDMA and psilocybin-assisted therapy. Among 294 adults (44% Black/African American or Mixed Race with Black ancestry, 56% White American; average age 36.3 years), psychoeducation increased interest and positivity across both groups. Greater depression and PTSD symptom severity was linked to higher baseline interest in both groups, and Black participants with more severe depression showed even greater interest and more positive views. The findings suggest that research groups, not potential participants, are responsible for diversifying clinical trial samples and that rebuilding trust and providing culturally attuned interventions is needed.
Psychotherapy
January 13, 2025
Roman Palitsky, Jessica L Maples-Keller, Caroline Peacock et al.
13 citations
In an open-label trial of psilocybin-assisted therapy for cancer-related demoralization and chronic pain, patients, facilitators, and caregivers identified key components and improvements for the treatment protocol. Using the Enhanced Critical Incident Technique, interviews revealed critical incidents, wish list items, and contributing factors related to therapy aspects like intention-setting and overall protocol transitions. The findings emphasize tailoring treatment to individual medical history, supporting common therapeutic factors, and ensuring collaborative care. Nine topic areas for protocol improvement emerged from the data.
Biological psychiatry
February 15, 2025
Jessica L Maples-Keller, Laura Watkins, Natalie Hellman et al.
12 citations
Treatment approaches for posttraumatic stress disorder (PTSD) based on fear conditioning and extinction models are reviewed. Fear extinction provides a translational model linking basic research in nonhuman animals to human treatments such as prolonged exposure therapy. Cognitive aspects of extinction, including consolidation and reconsolidation, are discussed along with behavioral and pharmacological strategies for preventing and treating chronic PTSD. Augmentation strategies reviewed include disrupting noradrenergic processes, NMDA receptor medications, physical exercise, cannabinoids, estradiol, dexamethasone, yohimbine, losartan, dopamine, and MDMA, with evidence for their efficacy in human samples. Limitations and future directions are also addressed.
Contemporary clinical trials communications
February 1, 2025
Jessica L Maples-Keller, Boadie W Dunlop, Barbara O Rothbaum
5 citations
An open-label pilot trial will test whether 100 mg of MDMA combined with massed exposure therapy—daily sessions for two weeks—is feasible for treating PTSD. The authors argue that combining MDMA with a gold-standard exposure treatment has translational support and strong dissemination potential. The study aims to enroll at least 15 adults with PTSD over two years to develop a treatment manual, which will later be tested in a randomized, placebo-controlled trial. This approach could improve the ability to treat PTSD.
Psychotherapy (Chicago, Ill.)
June 1, 2026
Roman Palitsky, Laura E Captari, Jessica L Maples-Keller et al.
3 citations
The relational spirituality model (RSM) provides a framework for developing spiritual and religious competence in psychedelic-assisted psychotherapies. Psychedelic-assisted therapies can provoke personally meaningful spiritual or existential experiences linked to improved outcomes. The RSM's inclusive spiritual, existential, religious, and theological approach offers a pluralistic way to engage diverse traditions in therapy. The article describes the RSM and introduces pragmatic training methods—deliberate practice, experiential components, SERT groups, and assessment training—that can be integrated into existing mental health or psychedelic therapy training programs. It also discusses how the RSM can inform interdisciplinary collaborations across disciplines and healing communities.
Journal of psychoactive drugs
October 23, 2024
Jessica L Maples-Keller, Courtland S Hyatt, Nathaniel L Phillips et al.
2 citations
A randomized, placebo-controlled trial with 34 healthy adults examined whether a single dose of MDMA alters five-factor model personality traits and affective states 48 hours later. No statistically significant changes were observed for the four pre-registered hypotheses, but medium effect sizes emerged: trait Openness increased (d = .79) and Positive Affect increased (d = .51) compared to placebo. These preliminary findings suggest MDMA may produce short-term shifts in openness and positive mood, warranting larger, longer-term studies to clarify how such changes might inform MDMA-assisted therapy.
Psychedelic medicine (New Rochelle, N.Y.)
June 1, 2025
Sierra Carter, Grace Packard, Jessica L Maples-Keller
Black Americans are underrepresented in psychedelic trials despite high mental health needs. In four focus groups with low-income, urban Black participants, three themes emerged: informed hesitation mixed with openness; trust, autonomy, and choice; and practical solutions to improve access. Participants voiced concerns about racism in healthcare, research, drug policy, and criminalization. They emphasized building trust through community investment, autonomy, and addressing barriers like childcare and transportation. The findings support centering Black Americans' needs in psychedelic-assisted therapy to improve access and care quality.