At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
In Brief
A Phase 2 clinical trial evaluating Midomafetamine HCl, Placebo, and 1 other intervention for Anxiety. Completed, enrolled 18 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with anxiety associated with a life-threatening illness. The main question it aims to answer is: Does anxiety decrease in people receiving two sessions of MDMA-assisted therapy? Researchers will compare people receiving placebo with therapy to people receiving MDMA-assisted therapy. * Participants will undergo three non-drug preparatory therapy sessions before their first blinded session of MDMA or placebo with therapy. * Each medication session will be followed by three non-drug integrative therapy sessions. * After the second blinded medication session, participants receiving MDMA will complete a third open-label medication session. * Participants who received placebo will be given the option to crossover and receive three sessions of assisted therapy.
Study Details
Timeline
Interventions
Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.
Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Manualized therapy