Actively Recruiting
MDMA in Borderline Personality Disorder
Led by Yale University · Updated on 2026-01-22
10
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
C
Connecticut Mental Health Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test the effects of MDMA (3,4-methylenedioxymethamphetamine) on social cognition in adults with Borderline Personality Disorder.
CONDITIONS
Official Title
MDMA in Borderline Personality Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between the ages of 18-60 years
- Body weight between 110 and 210 pounds with a minimum body mass index (BMI) of 16.5
- Able to swallow pills
- Must provide a contact person willing and able to be reached in case of emergency and sign release of information for this contact
- People of childbearing potential must agree to use a highly effective birth control method one month before dosing and during the two-week follow-up
- Able to provide written informed consent
- Able to read and write English proficiently
- Diagnosis of Borderline Personality Disorder confirmed by specific interview criteria
- No exposure to MDMA in the last 6 months and no more than 10 lifetime uses of ecstasy
- Agree not to drive for 24 hours after treatment and to have a support person accompany them home
- Willingness to stay overnight at the study site after each session if recommended
- Not currently taking contraindicated medications like antidepressants, antipsychotics, mood stabilizers, or stimulants unless approved by the study physician
- For those in mental health care, sign releases to allow communication between study investigators and their healthcare providers
- For those not in mental health care, acknowledge receipt of local mental health resources
- All participants acknowledge receipt of local emergency resources
You will not qualify if you...
- History of bipolar disorder, schizophrenia, schizoaffective disorder, or current psychotic features
- Lifetime diagnosis of autism
- Serious suicide risk in the past 6 months
- Current substance use disorder in the last month or positive drug screen
- Severe substance use disorder in the last 6 months
- Significant history of serious medical or neurological illness
- Signs of major medical or neurological illness on examination or lab tests, including specific heart, liver, kidney, and electrolyte abnormalities
- History of valvulopathy or pulmonary hypertension
- Uncontrolled hypertension with blood pressure above 130/90 mmHg or baseline blood pressure below 90 mmHg systolic
- History of tachycardia with heart rate above 90 beats per minute
- Current pregnancy or breastfeeding
- Taking contraindicated medications unless stopped at least five half-lives before baseline
- Hypersensitivity to non-MDMA ingredients in the study medication
- Use of herbal and dietary supplements not approved by the study investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
S
Sarah K Fineberg, MD, PhD
CONTACT
A
Alexandra A Alario, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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