Skip to content

Inflammatory biomarker outcomes associated with MDMA-assisted therapy: an open-label exploratory study.

Jenna E Kachmarik, Jennifer M Loftis, Christopher S. Stauffer

Frontiers in Neuroscience 2026 DOI: 10.3389/fnins.2026.1716817 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Exploratory pilot study Open-label Peer reviewed
Sample size 23
Population Veterans with PTSD
Intervention MDMA-assisted group therapy
Duration End-of-intervention blood draw; 30-day follow-up for PTSD severity
Topics MDMA
Keywords Crp Il-6 Tnf-α Inflammation Inflammatory markers Posttraumatic stress disorder Veterans
Registration NCT05961527
Key points MDMA-assisted group therapy was associated with small increases in IL-6 and CRP, a small decrease in TNF-α, and baseline IL-6 and TNF-α were positively correlated with PTSD symptom severity.

Abstract

Posttraumatic stress disorder (PTSD) is associated with elevated inflammation and risk for chronic illness, yet few studies have examined inflammatory biomarker outcomes of PTSD interventions. Rapid PTSD symptom reduction has been observed following 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy, which leverages MDMA as a prosocial adjunct to psychotherapy. No studies have evaluated inflammatory biomarker outcomes of MDMA-assisted therapy. This exploratory pilot study examined within-person changes in inflammatory biomarkers during MDMA-assisted group therapy for Veterans with PTSD (www.clinicaltrials.gov, NCT05961527). Blood plasma samples were collected from 23 Veterans at baseline and end-of-intervention. Hedges' g effect sizes were calculated for interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and C-reactive protein (CRP). PTSD severity was assessed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at baseline and 30-day follow-up. Spearman's rho correlations were calculated among biomarkers, PTSD symptoms, and change scores. Small increases were observed in IL-6 (g = 0.24; 95% CI -0.25, 0.72) and CRP (g = 0.23; 95% CI -0.30, 0.74), and a small decrease in TNF-α (g = -0.24; 95% CI -0.69, 0.23). Baseline IL-6 and TNF-α were positively associated with baseline CAPS-5 scores (ρ = 0.45, 0.32). Higher baseline IL-6 weakly predicted symptom improvement (ρ = -0.25), and IL-6 change correlated with symptom change (ρ = 0.41). CRP showed weak negative associations with PTSD symptoms (ρ = -0.26). Findings suggest MDMA-assisted therapy may modulate inflammatory biomarkers and highlight biomarker-symptom relationships. Results are preliminary but may inform larger studies.

Comparable studies

Other non-randomized and open-label trials on MDMA, most cited first.

Study Year Design Participants
Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. Adults with chronic, treatment-resistant PTSD 2013 Long-term follow-up of a completed trial n = 19
First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. Patients with alcohol use disorder (AUD) following community alcohol detoxification 2021 Open-label safety and tolerability proof-of-concept study n = 14
MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial. Couples in which one partner was diagnosed with PTSD 2020 Pilot study n = 6
Culturally informed research design issues in a study for MDMA-assisted psychotherapy for posttraumatic stress disorder People of color with posttraumatic stress disorder 2019 Phase 2 open-label multisite study
The Consequences of 3,4-Methylenedioxymethamphetamine Induced CYP2D6 Inhibition in Humans Healthy male subjects 2008 Controlled clinical trial n = 15

Citations in the library

Explore topics