MDMA-assisted Psychotherapy for Anxiety Associated With a Life-threatening Illness
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.
Details
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.