MDMA for Borderline Personality Disorder

(MDMA in BPD Trial)

Overseen By Sarah K Fineberg, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must be taking: Hormonal contraceptives

Must not be taking: Prescribed medications

Disqualifiers: Bipolar, Schizophrenia, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effects of MDMA (also known as Ecstasy or Molly) on social understanding in adults with Borderline Personality Disorder. Participants will receive a single dose of MDMA to determine if it can improve their ability to relate to others. Suitable candidates have a Borderline Personality Disorder diagnosis and have not used MDMA in the past six months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed medications, except for hormonal contraceptives, before participating in the trial.

Is there any evidence suggesting that MDMA is likely to be safe for humans?

Research has shown that MDMA (also known as ecstasy) is generally safe in a clinical setting. One study on MDMA-assisted therapy found no serious side effects related to the drug, suggesting its safety in controlled environments. Another study found that MDMA-assisted therapy is safe and effective for treating PTSD (post-traumatic stress disorder). While these results are encouraging, this trial specifically tests MDMA for Borderline Personality Disorder. Researchers closely monitor participants in clinical trials to ensure their safety and to check for any possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Borderline Personality Disorder?

MDMA is unique for treating Borderline Personality Disorder (BPD) because it acts differently from standard treatments like psychotherapy and medications such as mood stabilizers and antidepressants. Most treatments for BPD focus on managing symptoms over time, but MDMA works by enhancing emotional processing and empathy during therapy sessions, potentially leading to faster and more profound therapeutic breakthroughs. Researchers are excited about MDMA because it targets the root emotional dysregulation in BPD, offering a new avenue for lasting change in just a few treatment sessions.

What evidence suggests that MDMA might be an effective treatment for Borderline Personality Disorder?

Research shows that MDMA therapy might help people with Borderline Personality Disorder (BPD). Early studies have shown promising results, with improvements in understanding social situations, a common challenge for those with BPD. In studies on other conditions like PTSD (post-traumatic stress disorder), MDMA-assisted therapy has proven safe and helpful. This trial will provide participants with one dose of open-label MDMA to further investigate its potential benefits for BPD. However, MDMA is not yet approved for treating BPD, and more research is needed to confirm its effectiveness. ^{2 4 5 6 7}

Who Is on the Research Team?

Sarah K Fineberg, MD, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing to remain overnight at the study site after each experimental session if recommended

Able to provide written informed consent according to Yale IRB guidelines

Able to read and write English proficiently

Exclusion Criteria

History of bipolar disorder, schizophrenia, schizoaffective disorder, or currently exhibiting psychotic features

My heart often beats faster than 90 beats per minute.

I have a history of serious medical or neurological illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one dose of open-label MDMA

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in social cognition and emotion appraisal

2 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MDMA

Trial Overview 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.

How Is the Trial Designed?

Group I: Open-Label MDMA Experimental Treatment 1 Intervention

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

MDMA is already approved in United States for the following indications:

Approved in United States as MDMA for:

• Posttraumatic stress disorder (PTSD)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Connecticut Mental Health Center

Collaborator

Trials

2

Recruited

160+

Published Research Related to This Trial

An estimated 0.9% of individuals aged 12 and older in the U.S. reported using ecstasy/MDMA in the past year, indicating that while use is relatively rare, it is more common among younger age groups and certain racial minorities.

Factors such as past-year use of other drugs, prescription drug misuse, nicotine dependence, and alcohol use disorder were associated with increased odds of ecstasy/MDMA use, highlighting the need for targeted prevention and harm reduction strategies for at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Correlates of Past Year Ecstasy/MDMA Use in the United States. Yang, KH., Kepner, W., Nijum, A., et al.[2023]

A systematic review of 16 studies and a meta-analysis of 10 studies involving 168 patients suggest that MDMA, when used in conjunction with psychotherapy, shows promising efficacy in treating post-traumatic stress disorder (PTSD).

The analysis highlights both the potential benefits and adverse events associated with MDMA treatment, indicating that it may be particularly beneficial for treatment-resistant patients, thus paving the way for future drug development in psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of MDMA (3,4-Methylenedioxymethamphetamine) for Post-traumatic Stress Disorder in Humans: A Systematic Review and Meta-Analysis. Tedesco, S., Gajaram, G., Chida, S., et al.[2021]

MDMA-assisted psychotherapy for treatment-resistant PTSD was found to be safe, with no serious adverse events reported during the trial involving 12 patients.

While there were no statistically significant reductions in PTSD symptoms measured by the Clinician-Administered PTSD Scale (CAPS), significant self-reported improvements were observed, and the effectiveness increased with more treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled pilot study of MDMA (± 3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD). Oehen, P., Traber, R., Widmer, V., et al.[2013]

In a study involving 39 healthy adults, MDMA did not reduce physiological or subjective stress responses during a public speaking task, contrary to the hypothesis that it would dampen stress reactions.

While MDMA is known for its potential benefits in treating PTSD, this research indicates that a single dose does not moderate acute stress responses, suggesting that its therapeutic effects may depend on different conditions or contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MDMA does not alter responses to the Trier Social Stress Test in humans. Bershad, AK., Miller, MA., de Wit, H.[2018]

In a small study of six women with chronic PTSD due to sexual assault, low doses of MDMA (50-75 mg) were found to be safe both psychologically and physiologically.

The study highlights the need for further research with larger sample sizes and higher doses to better understand the safety and efficacy of MDMA-assisted psychotherapy for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder. Bouso, JC., Doblin, R., Farré, M., et al.[2013]

MDMA-assisted psychotherapy (MDMA-AP) shows promise as a potential treatment for borderline personality disorder, which currently has limited options and high dropout rates.

The review suggests that MDMA-AP could improve treatment outcomes by targeting mechanisms similar to those seen in other disorders like posttraumatic stress disorder, and emphasizes the need for clinical trials to assess its safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MDMA-Assisted Psychotherapy for Borderline Personality Disorder. Traynor, JM., Roberts, DE., Ross, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10187385/

MDMA-Assisted Psychotherapy for Borderline Personality ... Conclusions. In summary, MDMA may have potential to improve treatment outcomes for individuals with borderline personality disorder. In ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06683014

NCT06683014 | MDMA in Borderline Personality Disorder The purpose of this study is to test the effects of MDMA (3,4-methylenedioxymethamphetamine) on social cognition in adults with Borderline Personality Disorder.

3. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20230681

MDMA and MDMA-Assisted Therapy | American Journal of ... A considerable body of preliminary evidence suggests that MDMA-AT delivered in a controlled clinical setting is a safe and efficacious treatment for PTSD.

4. akjournals.com akjournals.com/view/journals/2054/7/3/article-p227.xml

MDMA-assisted therapy for borderline personality disorder in Preliminary clinical studies for MDMA-AT have shown effective results. For example, six Phase II trials revealed that 54% of the study ...

5. researchgate.net researchgate.net/publication/377990947_MDMA-assisted_dialectical_behavioral_therapy_for_borderline_personality_disorder_A_qualitative_study_of_mental_health_clinicians

(PDF) MDMA-assisted dialectical behavioral therapy for ... MDMA-assisted therapy is not US Food and Drug Administration (FDA) approved in treating borderline personality disorder (BPD), and while PTSD is ...

6. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20230681

MDMA and MDMA-Assisted Therapy | American Journal of ... A considerable body of preliminary evidence suggests that MDMA-AT delivered in a controlled clinical setting is a safe and efficacious treatment for PTSD.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3122379/

the first randomized controlled pilot study The rate of clinical response was 10/12 (83%) in the active treatment group versus 2/8 (25%) in the placebo group. There were no drug-related serious adverse ...