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Open-Label MDMA for Borderline Personality Disorder (MDMA in BPD Trial)

Phase 2
Waitlist Available
Led By Sarah K Fineberg, MD, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Adults between the ages of 18-60 years
* Body weight between 110 and 210 pounds. Minimum body mass index (BMI) 16.5.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (immediately before drug dose) to 2 hours after drug dose on the same day.
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study is to test the effects of MDMA (3,4-methylenedioxymethamphetamine) on social cognition in adults with Borderline Personality Disorder.

Who is the study for?
This trial is for adults with Borderline Personality Disorder. Specific eligibility criteria are not provided, but typically participants must meet diagnostic criteria for the condition being studied and may need to pass certain health checks.
What is being tested?
The study is testing the effects of MDMA on social cognition in individuals with Borderline Personality Disorder. Social cognition involves how people process, store, and apply information about others and social situations.
What are the potential side effects?
While specific side effects are not listed here, common side effects of MDMA can include anxiety, agitation, increased heart rate and blood pressure, muscle tension, sweating, nausea, blurred vision, insomnia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (immediately before drug dose) to 2 hours after drug dose on the same day.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (immediately before drug dose) to 2 hours after drug dose on the same day. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Self-Reported Social Cognition After 1 Dose of MDMA.
Secondary study objectives
Change from baseline in emotion appraisal on facial emotion recognition task score, on same day after drug administration.

Side effects data

From 2018 Phase 1 & 2 trial • 12 Patients • NCT02876172
33%
Anxiety
17%
Insomnia
17%
Visual Impairment
17%
Vomiting
17%
Upper respiratory tract infection
17%
Arthropod bite
17%
Disturbance in attention
17%
Dizziness
17%
Paresthesia
17%
Nasal congestion
17%
Dyspnoea
17%
Oropharyngeal pain
17%
Rhinorrhoea
17%
Pruritis
17%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
PTSD Patients at 6-month Follow-up
CSO Patients at 6-month Follow-up
PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-Label MDMAExperimental Treatment1 Intervention
Participants will receive one dose of open-label 3,4-methylenedioxymethamphetamine (MDMA).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MDMA
2023
Completed Phase 2
~410

Find a Location

Who is running the clinical trial?

Connecticut Mental Health CenterUNKNOWN
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Borderline Personality Disorder
150 Patients Enrolled for Borderline Personality Disorder
Yale UniversityLead Sponsor
1,922 Previous Clinical Trials
3,031,509 Total Patients Enrolled
5 Trials studying Borderline Personality Disorder
225 Patients Enrolled for Borderline Personality Disorder
Sarah K Fineberg, MD, PhDPrincipal InvestigatorYale School of Medicine
~7 spots leftby Jun 2026
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