Nature Medicine
June 1, 2021
Jennifer Mitchell, Michael P. 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 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.
Focus (American Psychiatric Publishing)
July 1, 2023
Jennifer Mitchell, Michael P. 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.
Frontiers in Psychiatry
January 24, 2022
Tigran Makunts, Lisa Jerome, Ruben Abagyan et al.
19 citations
MDMA, also known as ecstasy, is being studied as a treatment for PTSD and anxiety, with approval expected soon. Although MDMA affects serotonin and could theoretically cause serotonin syndrome—a potentially dangerous condition—no cases have occurred in clinical trials. A review of FDA adverse event reports found 20 cases of serotonin syndrome in people who took MDMA, but all had also used other serotonergic drugs such as amphetamines, stimulants, or opioids. No cases were linked to MDMA alone. These findings suggest that serotonin syndrome from MDMA alone is rare or absent in the available data.
Frontiers in Psychiatry
May 18, 2023
Tigran Makunts, Diane Dahill, Lisa Jerome et al.
6 citations
MDMA is being tested as a treatment aid for PTSD and anxiety disorders, and regulatory approval is expected soon. Its main effects involve increasing serotonin, norepinephrine, and dopamine activity, which can raise heart rate and blood pressure. Clinical trials have limited data on cardiac side effects due to small participant numbers and restricted use of other drugs. An analysis of FDA adverse event reports found 17 cardiovascular cases where people took MDMA plus other substances. All accompanying drugs—opioids, stimulants, anticholinergics, and amphetamines—are already linked to heart problems. In none of these reports was MDMA considered the primary cause.
Nat Med
November 1, 2024
Jennifer Mitchell, Marcela Ot’alora G., Bessel Van der Kolk et al.
4 citations
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