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.
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.
European journal of psychotraumatology
December 1, 2025
Gabrielle Agin-Liebes, Richard J Zeifman, Jennifer M Mitchell
11 citations
MDMA-assisted therapy (MDMA-AT) for severe posttraumatic stress disorder (PTSD) improves self-compassion, which may explain its therapeutic benefits. In a double-blind trial with 82 adults, MDMA-AT significantly increased compassionate self-responding (self-kindness, common humanity, mindfulness) and decreased uncompassionate self-responding (self-judgment, isolation, over-identification) compared to placebo plus therapy, with large effect sizes on most subscales. Changes in self-compassion fully mediated the reduction in PTSD severity and depressive symptoms, but not in alcohol or substance use. Self-compassion appears to be a key psychological mechanism in MDMA-AT, suggesting that targeting it could refine treatments for PTSD with co-occurring depression.
Journal of psychoactive drugs
January 1, 2024
Kelan L Thomas, Robert Jesse, Nicky J Mehtani et al.
4 citations
Policymakers are increasingly using clinical trial data to justify deprioritizing, decriminalizing, or legalizing psychedelic substances, but personal possession limits written into law often lack scientific grounding. This commentary argues that allowable amounts should be based on moderate-high doses shown safe and effective in clinical trials, common naturalistic use, and dose-equivalence studies. The authors provide a table of evidence-informed moderate-high doses for seven psychedelics to guide consistent and equitable policy limits, aiming to replace arbitrary thresholds with scientifically justified ones.
Current topics in behavioral neurosciences
November 22, 2025
Maha N Mian, Allison R Coker, Grace Kretzer et al.
Communities that use psychedelics as religious sacraments have developed their own frameworks for safety and hold distinct views on risk and harm. To better understand their lived realities, researchers can collaborate closely with these communities using community-based participatory research (CBPR) practices, which center communities in co-creating research, improve engagement, build trust, and highlight local priorities. This paper presents preliminary findings from a CBPR study with entheogenic communities, sharing lessons learned from forming a community advisory board and initial pilot data gathering. Lessons include consulting community engagement experts, considerations for compensation and confidentiality, using multimodal recruitment strategies, and recognizing the unique historical context of these communities. These lessons aim to develop best practices for psychedelic research, policy, and public education.