This Phase II pilot study is a randomized, double-blind, placebo-controlled study in 18 participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy.
The trial tests whether MDMA-assisted therapy reduces anxiety associated with life-threatening illness compared with placebo plus manualised therapy.
Eighteen participants were randomised (13 active, 5 placebo) to two blinded experimental sessions of MDMA (125 mg with optional 62.5 mg supplemental) or inactive placebo, each session lasting six to eight hours and scheduled two to four weeks apart.
Three preparatory non-drug therapy sessions precede the first experimental session; each medication session is followed by three integrative therapy sessions. After unblinding, active participants received a third open-label MDMA session and placebo participants could cross over to active treatment.
Two blinded MDMA-assisted therapy sessions (125 mg, optional 62.5 mg supplemental) with manualised therapy; open-label third session after unblinding for active participants.
Optional supplemental dose 62.5 mg given 1.5–2.5 h after initial; open-label third session offered after unblinding.
Inactive placebo; optional supplemental inactive placebo 1.5–2.5 h after initial.
Manualised therapy with inactive placebo administered on two blinded experimental sessions; option to cross over to open-label MDMA sessions.
Inactive placebo; optional supplemental inactive placebo 1.5–2.5 h after initial.
In an interpretative phenomenological analysis of participant narratives from a pilot phase 2 trial, MDMA-assisted therapy for anxiety related to life‑threatening illness was reported to facilitate processing of trauma and grief, evoke mystical/existential experiences and reduce physiological arousal, yielding improved coping, reduced psychological symptoms, greater vitality and a reconnection to life. These accounts suggest MDMA‑AT may bolster emotional resilience in the face of illness relapse, though trial limitations temper conclusions and indicate the need for further study.