Social Anxiety MDMA-Assisted Therapy Investigation

This is a randomised, open-label delayed treatment trial (n=90) aiming to evaluate the safety and efficacy of MDMA-assisted therapy for social anxiety disorder (SAD) in adults.

Led by Jason B Luoma at the Portland Psychotherapy Clinic, Research, and Training Center, this study targets participants aged 18 to 65 who reside in the Portland, OR, area and are fluent in English.

The trial involves two experimental sessions of MDMA-assisted therapy, with half of the participants receiving immediate treatment upon enrolment and the other half undergoing a 16-week wait period before treatment. Each experimental session includes manualised therapy alongside MDMA administration.

The primary outcome measure is the Liebowitz Social Anxiety Scale (LSAS) score assessed by a blinded Independent Rater. Additional assessments include measures of functional impairment, internalised shame, acceptance of self-conscious emotions, subjective belonging, self-concealment, and self-compassion. Recruitment commenced in April 2022 and is expected to conclude in August 2025.

Topic Anxiety
Compound MDMA
Country United States of America
Visit trial
Status Active, not recruiting
Results Published No
Start date 13 April 2022
End date 31 August 2025
Phase Phase II
Design Open
Type Interventional
Participants 88
Sex All
Age 18- 65
Therapy Yes

Trial Details

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.

NCT Number NCT05138068

Sponsors & Collaborators

Portland Psychotherapy Clinic
Portland Psychotherapy is a clinic, research and training centre with a unique business model that funds scientific research.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.