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Ann Berger

Pain and Palliative Care, National Institutes of Health Clinical Center, Bethesda, MD, USA.

6 papers in the library · 161 citations · publishing 2022-2025

Papers

Psilocybin-assisted therapy improves psycho-social-spiritual well-being in cancer patients.

Journal of affective disorders February 15, 2023 Sarah Shnayder, Rezvan Ameli, Ninet Sinaii et al. 67 citations

Psilocybin-assisted therapy improved psycho-social-spiritual well-being in cancer patients with major depressive disorder, as measured by the NIH-HEALS. In a Phase II open-label trial, 30 participants received 25 mg of psilocybin with group preparation and integration sessions. NIH-HEALS scores increased significantly after treatment, with gains in all three factors: Connection (12.7%), Reflection & Introspection (7.7%), and Trust & Acceptance (22.4%). Improvements appeared by day 1 and persisted through 8 weeks. The study lacked a control group, relied on self-reports, and had a small, limited sample, restricting generalizability. The results suggest that Connection, Reflection & Introspection, and Trust & Acceptance are key elements of psycho-social-spiritual healing in this context.

Psychedelic drug abuse potential assessment research for new drug applications and Controlled Substances Act scheduling

Neuropharmacology August 17, 2022 Jack E Henningfield, Marion A Coe, Roland R Griffiths et al. 34 citations

New medicines containing classic hallucinogenic and entactogenic psychedelics like psilocybin, LSD, and MDMA are being developed for psychiatric and neurological disorders. These substances are currently Schedule I under the US Controlled Substances Act (CSA) and similarly controlled globally. The CSA framework governs research, drug approval, and rescheduling; upon FDA approval, a drug containing a Schedule I substance must be rescheduled. Abuse potential research informs the eight CSA factors used for rescheduling, as well as product labeling and required risk evaluation and mitigation strategies (REMS). Standard human abuse potential studies are problematic for strong hallucinogens like psilocybin, so alternative strategies are discussed. Abuse-related research may also illuminate mechanisms of action, therapeutic effects, and effects on brain, behavior, mood, spirituality, and consciousness.

Are psychedelic medicines the reset for chronic pain? Preliminary findings and research needs

Neuropharmacology April 2, 2023 Farah Z Zia, Michael H Baumann, Sean J Belouin et al. 28 citations

Chronic pain is a leading cause of disability and opioid overdose in the United States. While many people manage pain with existing medicines and psychosocial treatments, others find these options ineffective or unacceptable due to side effects and risks. Preliminary evidence suggests psychedelics may improve quality of life, functionality, and reduce disability and distress for people whose pain may never be completely relieved. This commentary calls for more basic research and clinical trials to explore psychedelics' potential in chronic pain management, and to determine whether effects stem from direct antinociceptive or anti-inflammatory mechanisms, or from increased tolerability, acceptance, and spirituality that mediate therapeutic effects seen in psychiatric disorders.

Psychedelic Science, Contemplative Practices, and Indigenous and Other Traditional Knowledge Systems: Towards Integrative Community-Based Approaches in Global Health.

Journal of psychoactive drugs January 1, 2023 Julian Urrutia, Brian T Anderson, Sean J Belouin et al. 21 citations

Combining psychedelic science, contemplative practices, and Indigenous and other traditional knowledge systems in integrative, community-based models of care could transform global health. Both contemplative practices and certain psychedelic substances reliably induce self-transcendent experiences that positively affect health, well-being, and prosocial behavior, and combining them appears synergistic. Traditional knowledge systems offer ethnobotanical expertise and time-tested practices. A decolonized agenda for psychedelic research requires collaborative engagement with traditional knowledge stewards to co-develop evidence-based integrative care accessible to their communities. Health systems could include Indigenous and traditional healers as stakeholders in designing, implementing, and evaluating community-based approaches for safely scaling psychedelic treatments.

National Institutes of Health psilocybin research speaker series: State of the science, regulatory and policy landscape, research gaps, and opportunities.

Neuropharmacology June 1, 2023 Dan Xi, Ann Berger, David Shurtleff et al. 11 citations

In 2021, the U.S. National Institutes of Health (NIH) held its first-ever speaker series focused on a psychedelic substance, titled the 'NIH Psilocybin Research Speaker Series,' from April 22 to June 10. The series aimed to provide evidence-based information to the public and scientific community, assess the current state of psilocybin science, review regulatory and policy landscapes, and identify knowledge gaps to define future research needs. Highlights from lectures and discussions by 26 national and international experts formed the basis for a Special Issue of Neuropharmacology.

Effects of a combined nature-based and audio-based virtual mindfulness intervention on stress and wellbeing of COVID-19 healthcare workers: a randomized controlled trial.

PeerJ January 1, 2025 Polycarpe Bagereka, Rezvan Ameli, Ninet Sinaii et al.

Nature-based programs can improve overall wellbeing among healthcare workers who experienced stress during the COVID-19 pandemic, and adding an audio-based mindfulness intervention may enhance those benefits. In a study of 78 healthcare workers randomized to a nature-only retreat, a combined nature-and-mindfulness program, or a control group, wellbeing scores increased in both intervention groups compared to the control. The combined group maintained improvements at follow-up better than the nature-only group. However, neither intervention reduced perceived stress, as measured by the Perceived Stress Scale. The authors note the study had diminished power and call for further research.