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.
Nature medicine
October 1, 2023
Jennifer M. Mitchell, Marcela Ot’alora G., Bessel Van der Kolk et al.
400 citations
In a phase 3 trial, MDMA-assisted therapy reduced PTSD symptoms and functional impairment more than placebo with therapy in 104 participants with moderate to severe PTSD. The average decrease in PTSD symptom severity was 23.7 points with MDMA-assisted therapy versus 14.8 points with placebo, and functional disability improved by 3.3 versus 2.1 points. Participants were ethnoracially diverse, with 27% identifying as Hispanic/Latino and 34% as other than White. Severe side effects occurred in 9.4% of the MDMA group and 3.9% of the placebo group; no deaths or serious adverse events were reported. The treatment was generally well tolerated.
Comprehensive psychiatry
November 1, 2016
Paulo César Ribeiro Barbosa, Rick J Strassman, Dartiu Xavier Da Silveira et al.
104 citations
Regular ritual use of hoasca (ayahuasca) within a Brazilian religious group in the United States is associated with lower depression and confusion, higher agreeableness and openness, better memory performance, and less recent alcohol use compared to matched controls. The study of 30 members of the União do Vegetal and 27 non-user controls found no adverse effects on neuropsychological function. Lifetime hoasca use correlated with fewer physical health role limitations and less heavy alcohol use, suggesting the religious use of this psychedelic brew may have positive effects on mood and substance use.
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.
Psychology of Addictive Behaviors
June 5, 2023
Gabrielle Agin-Liebes, Elizabeth M Nielson, Michael Zingman et al.
42 citations
In a small qualitative study of the first randomized controlled trial of psilocybin-assisted psychotherapy for alcohol use disorder, participants reported that the treatment helped them process emotions tied to painful past events, fostered self-compassion, self-awareness, and feelings of interconnectedness. The acute drug sessions laid the groundwork for more self-compassionate regulation of negative affect. Participants also described newfound belonging and improved relationship quality. The findings suggest psilocybin increases the malleability of self-related processing, reduces shame and self-critical thoughts, improves affect regulation, and lowers alcohol cravings, indicating that integrating self-compassion training with psychedelic therapy may enhance AUD treatment outcomes.
Nat Med
November 1, 2024
Jennifer M. Mitchell, Marcela Ot’alora G, Bessel Van der Kolk et al.
4 citations
No Summary
Addiction (Abingdon, England)
January 16, 2025
Noa Krawczyk, Megan Miller, Emma Yuanqi Gu et al.
2 citations
People in online opioid-use-disorder communities hold diverse views on using psychedelics to manage opioid use. Many report that psychedelics reduce physical dependence symptoms, shift motivations away from opioids, and address underlying mental health issues. Others see the promise as exaggerated, noting that many eventually return to opioid use or consider psychedelics dangerous. The findings underscore an urgent need for controlled studies to understand psychedelics' effects on opioid use, their integration with existing treatments, and safety strategies.
PsyArXiv
March 26, 2026
Broc A Pagni, Stephen Ross, Sarah Mennenga et al.
preprint
An open-label extension of a Phase II randomized controlled trial examined the safety and efficacy of psilocybin-assisted therapy for alcohol use disorder. Participants who had received either psilocybin or placebo in the main trial were offered two open-label psilocybin sessions. The treatment was well tolerated, with no serious adverse events attributed to psilocybin. Heavy drinking days decreased substantially from baseline, and the reduction was sustained through the 32-week follow-up. The findings suggest that psilocybin-assisted therapy may produce durable reductions in alcohol consumption among individuals with alcohol use disorder.