MDMA in Borderline Personality Disorder

NCT06683014 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2000037769
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Borderline Personality Disorder

Keywords

3,4-methylenedioxymethamphetamine; social cognition

Outcome Measures

Primary Outcomes (1)

• Change in Self-Reported Social Cognition After 1 Dose of MDMA.

  Defined as sociability visual-analogue scale (VAS) score. Total score range is 0-100, higher scores indicating more sociability.

  From baseline (immediately before drug dose) to 2 hours after drug dose on the same day.

Secondary Outcomes (1)

• Change from baseline in emotion appraisal on facial emotion recognition task score, on same day after drug administration.

  From baseline (immediately before drug dose) to 2 hours after drug dose on the same day.

Study Arms (1)

Open-Label MDMA

EXPERIMENTAL

Participants will receive one dose of open-label 3,4-methylenedioxymethamphetamine (MDMA).

Drug: MDMA

Interventions

MDMA DRUG

Participants will receive one dose of open-label 3,4-methylenedioxymethamphetamine (MDMA).

Also known as: 3,4-methylenedioxymethamphetamine

Open-Label MDMA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults between the ages of 18-60 years
• Body weight between 110 and 210 pounds. Minimum body mass index (BMI) 16.5.
• Able to swallow pills.
• Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable and must sign release of information for this contact person.
• People of childbearing potential must agree to utilize a highly effective method of birth control (including the following, in accordance with Clinical Trials Facilitation and Coordination Group (CTFG) guidelines: combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation, including oral, intravaginal, and transdermal administrations; estrogen-only hormonal contraception associated with inhibition of ovulation, including oral, injectable, and implantable forms; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; abstinence from sexual activity with biological males) and for one month prior to dosing and for the duration of the two week follow-up period.
• Able to provide written informed consent according to Yale IRB guidelines.
• Able to read and write English proficiently.
• Diagnosis of BPD, as determined by the Diagnostic Interview for Personality Disorders BPD questions (DIPD), including endorsement of the criteria for abandonment fears and for stormy relationships.
• No exposure to MDMA in the last 6 months, and no more than 10 lifetime uses of ecstasy.
• Agree not to drive a motor vehicle for 24 hours after the treatment day. Agree to identify a support person to accompany them home after the medication day.
• Are willing to remain overnight at the study site after each experimental session until the next morning if recommended by the study physician
• Currently not taking contraindicated medications (antidepressants, antipsychotics, mood stabilizers, stimulants).
• Medications not on the contraindicated list must be reviewed and approved by the study PI
• For people in mental health care, signs releases for the study investigators to communicate with their mental healthcare provider and medical doctor(s) about their medical and mental health history and their mental and medical status during the study. When contacted, the mental healthcare provider confirms the ongoing treatment relationship.
• For people not in mental health care acknowledges receipt of local resources for mental healthcare.

You may not qualify if:

• History of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as determined by the Structured Clinical Interview for DSM5 (SCID-5) and/or clinician assessment.
• Lifetime diagnosis of autism.
• Serious suicide risk in the past 6 months, as assessed by Columbia Suicide Severity Rating Scale (CSSRS) type 4 or 5 ideation, or suicidal behavior (CSSRS item) or preparatory acts (CSSRS item).
• Any current substance use disorder (in the last 1 month) per SCID interview for alcohol or non-alcohol substances; or a positive pre-study (screening) urine drug screen.
• Any severe substance use disorder during the last 6 months.
• Any significant history of serious medical or neurological illness (including history of stroke, myocardial infarction, heart failure, cardiac arrhythmia, diabetes, family history of long-QT syndrome, etc.)
• History of valvulopathy or pulmonary hypertension (due to evidence of 5HT2B receptor agonism by MDMA)
• History of uncontrolled hypertension with baseline blood pressure above 130 mmHg (systolic) and over 90 mmHg (diastolic). Any history of syncope and/or study baseline blood pressure below 90 mmHg (systolic).
• History of tachycardia with baseline heart rate above 90 beats per minute.
• Current pregnancy or breastfeeding as assessed by patient report or by urine pregnancy test.
• Taking any contraindicated medications: antidepressants, mood stabilizers, antipsychotics, stimulants. No patient will be encouraged to discontinue medications for the study. We will allow people to participate who stopped contraindicated medications at least five half-lives before baseline assessments.
• Hypersensitivity to non-MDMA ingredients of the investigational medicine product (IMP), namely mannitol, magnesium stearate, and hydroxypropylmethylcellulose.
• Herbal and dietary supplements will be reviewed on a case-by-case basis by the sponsor-PI for decision about safety.

Sponsors & Collaborators

• Yale University: lead
• Connecticut Mental Health Center: collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Sarah K Fineberg, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah K Fineberg, MD, PhD

CONTACT

(203) 974-7265; fineberg.lab@yale.edu

Alexandra A Alario, PhD

CONTACT

(203) 974-7265; fineberg.lab@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)