Panacea Index Logo

Command Palette

Search for a command to run...

Social anxiety and MDMA-assisted therapy investigation: a novel clinical trial protocol.

Frontiers in psychiatry
May 5, 2023
M Kati Lear et al. (5 authors)
Journal ArticleHuman Study
Study Details

Study Goal

The researchers aimed to assess the preliminary treatment outcomes, feasibility, safety, and psychological/physiological processes of MDMA-assisted therapy (MDMA-AT) for social anxiety disorder (SAD).

Results Summary

The study protocol outlines a randomized, open-label delayed treatment design to evaluate MDMA-AT's potential for SAD symptom reduction, functional impairment, and therapeutic processes like shame and self-compassion. Results are pending as it is a protocol for a pilot study.

Population

20 participants with moderate-to-severe generalized social anxiety disorder (SAD).

Effective Dosage

Two oral doses of MDMA (specific amount not stated).

Duration

Approximately 16 weeks (including preparation, medicine, and integration sessions).

Interactions

None mentioned

Extracted Claims (11)
InterventionDirectionEndpointPopulationDosageImpactClaim #
MDMA-assisted therapy (MDMA-AT)
neutral
social anxiety disorder (SAD)
participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype
-
assess preliminary treatment outcomes
#1
MDMA-assisted therapy (MDMA-AT)
neutral
social anxiety disorder (SAD)
participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype
-
assess feasibility and safety
#2
MDMA-assisted therapy (MDMA-AT)
neutral
social anxiety disorder (SAD)
participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype
-
assess psychological and physiological processes of change
#3
MDMA-assisted therapy (MDMA-AT)
neutral
social anxiety disorder (SAD)
-
-
development of a treatment manual
#4
MDMA-assisted therapy (MDMA-AT)
decrease
SAD symptom reduction as measured by the Liebowitz Social Anxiety Scale
participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype
-
primary outcome is SAD symptom reduction
#5
MDMA-assisted therapy (MDMA-AT)
neutral
functional impairment
participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype
-
secondary outcomes include changes in functional impairment
#6
MDMA-assisted therapy (MDMA-AT)
neutral
feasibility and safety measures
participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype
-
secondary outcomes include changes in feasibility and safety measures
#7
MDMA-assisted therapy (MDMA-AT)
neutral
shame and shame-related coping
participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype
-
secondary outcomes include changes in novel therapeutic processes of change including shame and shame-related coping
#8
MDMA-assisted therapy (MDMA-AT)
neutral
belongingness
participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype
-
secondary outcomes include changes in novel therapeutic processes of change including belongingness
#9
MDMA-assisted therapy (MDMA-AT)
neutral
self-concealment
participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype
-
secondary outcomes include changes in novel therapeutic processes of change including self-concealment
#10
MDMA-assisted therapy (MDMA-AT)
neutral
self-compassion
participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype
-
secondary outcomes include changes in novel therapeutic processes of change including self-compassion
#11
Abstract

BACKGROUND: Social anxiety disorder (SAD) is a serious and prevalent psychiatric condition that heavily impacts social functioning and quality of life. Though efficacious treatments exist for SAD, remission rates remain elevated and a significant portion of those affected do not access effective treatment, suggesting the need for additional evidence-based treatment options. This paper presents a protocol for an open-label pilot study of MDMA-assisted therapy (MDMA-AT) for social anxiety disorder. The study aims to assess preliminary treatment outcomes, feasibility and safety, and psychological and physiological processes of change in the treatment of SAD with MDMA-AT. A secondary aim includes the development of a treatment manual for MDMA-AT for SAD. METHOD: The outlined protocol is a randomized, open-label delayed treatment study. We will recruit 20 participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype. Participants will be randomly assigned to an immediate treatment (n = 10) or delayed treatment condition (n = 10). Those in the immediate treatment condition will proceed immediately to active MDMA-AT consisting of three preparation sessions, two medicine sessions in which they receive oral doses of MDMA, and six integration sessions over approximately a 16-week period. The delayed treatment condition will receive the same intervention after a 16-week delay. Our primary outcome is SAD symptom reduction as measured by the Liebowitz Social Anxiety Scale administered by blinded raters at post-treatment and 6 month follow up. Secondary outcomes include changes in functional impairment, feasibility and safety measures, and novel therapeutic processes of change including shame and shame-related coping, belongingness, self-concealment, and self-compassion at post-treatment. Exploratory outcomes are also discussed. DISCUSSION: The results of this pilot trial advance the field's understanding of the acceptability and potential effectiveness of MDMA-AT for social anxiety disorder and provide an overview of relevant therapeutic mechanisms unique to SAD. We hope findings from this protocol will inform the design of subsequent larger-scale randomized controlled trials (RCT) examining the efficacy of MDMA-AT for SAD. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, NCT05138068.

Study Links
Quality Scores
SafetyNot Assessed
Efficacy70/10
Quality80/10
Citation Metrics
Total Citations3
Citations/Year1.5
Relative Citation Ratio1.02
NIH Percentile50.9%
Research Impact Scores
APT Score0.25
Weight Score2.59
Normalized Score0.64
Related Supplements
Social anxiety and MDMA-assisted therapy investigation: a no... | Panacea Index