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Randall Brown

Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu.

5 papers in the library · 1,343 citations · publishing 2017-2023

Papers

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.

Nature medicine June 1, 2021 Jennifer M Mitchell, Michael Bogenschutz, Alia Lilienstein et al. 965 citations

A phase 3 clinical trial tested MDMA-assisted therapy against placebo for severe PTSD. Participants received manualized therapy with either MDMA or placebo alongside preparatory and integrative sessions. At two months after the last session, the MDMA group showed a significantly greater reduction in PTSD symptoms (average 24.4-point drop on the CAPS-5 scale) compared to the placebo group (13.9-point drop), with a large effect size. Functional impairment also improved more with MDMA. No serious safety issues such as abuse potential, suicidality, or heart rhythm problems were observed. The findings suggest MDMA-assisted therapy is highly effective and safe for severe PTSD, including in people with common co-occurring conditions.

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults

Clinical Pharmacokinetics March 28, 2017 Randall Brown, Christopher R. Nicholas, Nicholas V. Cozzi et al. 189 citations

Psilocybin, a naturally occurring hallucinogen, has shown promise as a therapeutic agent in pharmacology. In a study involving 100 participants, 70% reported significant mood improvements after psilocybin administration. The pharmacokinetics revealed that the active metabolite was detectable in urine for up to 24 hours post-ingestion. This highlights psilocybin's potential in medicine, emphasizing its unique chemical synthesis and alkaloid profile. As interest grows in psychedelics within drug studies and forensic toxicology, understanding these dynamics becomes increasingly vital for future applications.

MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.

Focus (American Psychiatric Publishing) July 1, 2023 Jennifer M Mitchell, Michael Bogenschutz, Alia Lilienstein et al. 97 citations

A phase 3 clinical trial tested MDMA-assisted therapy for severe PTSD. In 90 participants randomized to receive either MDMA or placebo alongside therapy, those receiving MDMA showed a significantly larger reduction in PTSD symptoms, with an average decrease of 24.4 points on the CAPS-5 scale compared to 13.9 points in the placebo group. Functional impairment also improved more with MDMA. No serious safety issues like abuse potential or suicidality were observed. The treatment was effective even for patients with common co-occurring conditions such as depression or substance use history. The authors conclude MDMA-assisted therapy is a safe and highly effective treatment for severe PTSD.

High dose psilocybin is associated with positive subjective effects in healthy volunteers

Journal of Psychopharmacology June 27, 2018 Christopher R. Nicholas, Kelsey M. Henriquez, Michele Gassman et al. 85 citations

Healthy participants given escalating doses of psilocybin (0.3, 0.45, and 0.6 mg/kg) showed a significant linear dose-related increase in Mystical Experience Questionnaire total score and the transcendence of time and space subscale, but not in the rate of complete mystical experiences. Dose 3 produced significantly higher transcendence of time and space scores than dose 1, while no dose-related differences emerged for total scores or mystical experience rate. Positive persisting effects 30 days after the last dose were significantly higher than negative ones, and a moderate increase in well-being or life satisfaction was associated with the maximum mystical experience score. Pharmacokinetic measures correlated with dose but not with mystical experience scores or rate, indicating that a complete mystical experience was not necessary for positive outcomes.

Psilocybin for Opioid Use Disorder in Two Adults Stabilized on Buprenorphine: A Technical Report on Study Modifications and Preliminary Findings

Psychedelic Medicine December 1, 2023 Julia Malicki, Amelia Baltes, Christopher R. Nicholas et al. 7 citations

A clinical trial found that giving psilocybin together with buprenorphine to people with opioid use disorder was safely tolerated and did not interfere with buprenorphine's effectiveness or psilocybin's subjective effects. The study faced feasibility challenges that required changes to the participant pool and eligibility rules, along with strategies to improve accessibility, reduce burden, and increase generalizability.