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

Anxiety Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness

Status Completed

Clinical Trial Summary

This Phase 2 pilot study is a randomized, double-blind, placebo-controlled study in 18 participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy. Thirteen participants were randomized to the active dose condition of 125 mg of MDMA (plus an optional supplemental dose of 62.5 mg MDMA) with therapy and five participants were randomized to the placebo with therapy condition. The study will consist of two blinded experimental sessions of MDMA-assisted therapy or placebo with therapy, each session lasting six to eight hours and scheduled two to four weeks apart. Each participant will be unblinded one month after their second experimental session in Stage 1. After unblinding, participants receiving placebo will have the opportunity to cross over to open-label Stage 2 and receive active MDMA. Only subjects who receive active dose MDMA will complete an optional third open-label experimental session.

Clinical Trial Description

Individuals facing, or who have faced, a life-threatening illness contend with more than just the physical symptoms of their condition and may experience anxiety, depression, anger, and despair that can exacerbate their distress. Research suggests that diagnosis of, and living with a life-threatening illness can result in symptoms similar to those seen in posttraumatic stress disorder (PTSD).

3,-4-methylenedioxymethamphetamine (MDMA) is a monoamine releaser with a unique pharmacological profile that include decreased feelings of fear, increased positive mood and increased interpersonal trust. Findings from clinical trials in people with PTSD and anecdotal reports suggest that MDMA-assisted psychotherapy may assist people who have anxiety related to having a life-threatening illness.

This Phase 2 pilot study is a randomized, double-blind, placebo-controlled study in 18 participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy. Thirteen participants were randomized to the active dose condition of 125 mg of MDMA (plus an optional supplemental dose of 62.5 mg MDMA) with therapy and five participants were randomized to the placebo with therapy condition. The study will consist of two blinded experimental sessions of MDMA-assisted therapy or placebo with therapy, each session lasting six to eight hours and scheduled two to four weeks apart. Each participant will be unblinded one month after their second experimental session in Stage 1. After unblinding, participants receiving MDMA will complete a third open-label experimental session of MDMA-assisted therapy and participants who originally received placebo will have the opportunity to cross over to open-label Stage 2 and receive active MDMA-assisted therapy in 3 sessions.

The primary objective of the study is to assess changes in trait anxiety in subjects receiving active dose MDMA compared to those receiving placebo as measured by State-Trait Anxiety Index (STAI) Trait scores from Baseline to the Primary Endpoint (one month after the second experimental session). ;

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

• NCT number: NCT02427568
• Study type: Interventional
• Source: Lykos Therapeutics
• Status: Completed
• Phase: Phase 2
• Start date: May 14, 2015
• Completion date: May 17, 2018