MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness

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.

Timeline

Start

2015-05-14

Primary completion

2017-04-25

Completion

2018-05-17

Publications

• Results Wolfson PE, Andries J, Feduccia AA, Jerome L, Wang JB, Williams E, Carlin SC, Sola E, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study. Sci Rep. 2020 Nov 24;10(1):20442. doi: 10.1038/s41598-020-75706-1.

Drugs

Indications