Social Anxiety MDMA-Assisted Therapy Investigation

Brief Summary

This is a randomized, open-label delayed treatment study to assess the safety and effect of MDMA-assisted therapy in treating 20 participants diagnosed with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype. This study will obtain an estimate of effect size for two experimental sessions of MDMA-assisted therapy for the treatment of social anxiety disorder on measures of safety, social anxiety, functional outcomes, psychiatric symptoms, and putative mechanisms of action. The primary outcome for this study will be the Liebowitz Social Anxiety Scale (LSAS) administered by a blinded Independent Rater (IR). Other assessments, including physiological, self-report, and behavioral tasks will be used to assess other exploratory variables. An additional aim of the trial will be the development of a treatment manual for MDMA-AT for SAD for future research.

Intervention / Treatment

  • Drug: MDMA
  • Behavioral: Psychotherapy

Condition or Disease

  • Social Anxiety Disorder


Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 18 Years to 65 Years   (Adult, Older Adult)
Enrollment: 20 ()
Funded by: Other


Clinical Trial Dates

Start date: Apr 13, 2022
Primary Completion: Aug 01, 2024
Completion Date: Feb 01, 2025
Study First Posted: Nov 30, 2021
Last Updated: Apr 25, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

SAD is a prevalent and disabling disorder characterized by intense fear of being scrutinized or negatively evaluated by others in social situations. SAD is the fourth most commonly diagnosed psychological disorder in the United States with onset commonly occurring in adolescence and assuming a chronic course even when treated. Evidence-based treatments for SAD exist, including medications and therapy, but a significant proportion of patients fail to improve, indicating the need for novel effective treatments.

3,4-methylenedioxymethamphetamine (MDMA) is a monoamine releaser and re-uptake inhibitor with indirect effects on neurohormone release. The combined neurobiological effects appear to reduce defenses and fear of emotional injury, enhance communication and introspection, and can increase empathy and compassion. MDMA may also enhance fear extinction learning in humans. The subjective effects of MDMA appear to create a productive psychological state that enhances the therapeutic process. These subjective effects of MDMA create a productive psychological state that enhances the therapeutic process for the treatment of SAD and other anxiety disorders. A Phase 2 MDMA-assisted therapy (MDMA-AT) trial sponsored by MAPS has provided preliminary evidence that social anxiety among adults with autism is treatable with two MDMA-AT sessions and associated non-drug preparatory and integrative psychotherapy (Danforth et al., 2018).

In this open-label Phase 2 study intended to gather supportive data on the safety and effectiveness of MDMA-assisted therapy (MDMA-AT), each of the 20 subjects will participate in two experimental sessions, with half proceeding immediately into treatment once enrolled, and half receiving the experimental treatment after an initial 16 week wait. This study involves a dose of MDMA administered during the Treatment Period with manualized therapy in two monthly Experimental Sessions. This 8-week Treatment Period is preceded by three 90-minute non-drug Preparatory Sessions. Each experimental Session is followed by three 90-minute non-drug Integrative Sessions of non-drug psychotherapy. The Primary Outcome measure is assessed by a blinded Independent Rater at study enrollment, at the primary outcome assessment point (2-weeks after the final integration session), and follow up assessment 26 weeks later. Participants will also be offered the chance to sign up for a long-term follow up extension study at the follow up assessments (with long-term follow up conducted 24 months post-treatment).

Eligibility Criteria

Sex: All

This clinical trial is recruiting

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More Details

NCT Number: NCT05138068
Acronym: SAMATI
Other IDs: IUSA5
Study URL:
Last updated: Jun 17, 2022