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Social Anxiety MDMA-Assisted Therapy Investigation

NCT05138068 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

MDMA

Two 8-hour experimental sessions will occur within the 11-session intervention in which participants will take a dose of MDMA. In the first Experimental Session, the initial dose will be 80 mg MDMA, with a supplemental dose of 40 mg 1.5 to 2 hours later unless contraindicated. In the second Experimental Session, the initial dose may be increased to 120 mg MDMA unless contraindicated with an additional dose of 40 mg 1.5 to 2 hours after the initial dose is given unless contraindicated.

BEHAVIORAL

Psychotherapy

Adjunctive, manualized psychotherapy will be provided by a team of two therapists during the MDMA-assisted therapy sessions

Sponsors & Collaborators

  • Oregon Research Institute Center for Evaluation Services

    collaborator UNKNOWN

  • Multidisciplinary Association for Psychedelic Studies

    collaborator OTHER

  • Portland Psychotherapy Clinic, Research, and Training Center

    collaborator OTHER

  • Jason B Luoma

    lead OTHER

Principal Investigators

  • Jason B Luoma, Ph.D. · Portland Psychotherapy Clinic, Research, and Training Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2025-02-06
Completion
2025-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05138068 on ClinicalTrials.gov