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

Trial Summary

What is the purpose of this trial?

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

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.

What evidence supports the effectiveness of the drug MDMA for treating borderline personality disorder?

Research suggests that MDMA-assisted psychotherapy has shown promise in treating conditions similar to borderline personality disorder, like PTSD, by enhancing the effectiveness of therapy. This is based on studies where MDMA helped improve symptoms in PTSD patients, indicating potential benefits for borderline personality disorder as well. ^{1 2 3 4 5}

Is MDMA generally safe for humans?

MDMA has been used in clinical trials for PTSD, showing some promise, but it can also cause serious side effects like brain damage, psychiatric issues, and severe physical reactions such as high fever and heart problems. Even in its pure form, MDMA can lead to dangerous complications like brain bleeding, so it should not be considered a safe drug. ^{6 7 8 9 10}

How is the drug MDMA unique in treating Borderline Personality Disorder?

MDMA is unique because it acts on serotonin receptors and has been used in therapy for PTSD, showing potential for treating psychiatric disorders that are resistant to other treatments. Its ability to enhance mood and social interactions may offer a novel approach for conditions like Borderline Personality Disorder. ^{6 11 12 13 14}

Research Team

Sarah K Fineberg, MD, PhD

Principal Investigator

Yale University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Psychobiological problems in heavy 'ecstasy' (MDMA) polydrug users. [2022]

2. United States 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). [2013]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Can MDMA play a role in the treatment of substance abuse? [2019]

4. United States pubmed.ncbi.nlm.nih.gov

MDMA-Assisted Psychotherapy for Borderline Personality Disorder. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Psychiatric disorders and their correlates among young adult MDMA users in Ohio. [2013]

6. United States 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. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

3 cases of primary intracranial hemorrhage associated with "Molly", a purified form of 3,4-methylenedioxymethamphetamine (MDMA). [2013]

8. United States pubmed.ncbi.nlm.nih.gov

MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder. [2013]

9. Croatia pubmed.ncbi.nlm.nih.gov

[Ecstasy]. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Toxicity of MDA (3,4-methylenedioxyamphetamine) considered for relevance to hazards of MDMA (Ecstasy) abuse. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence and Correlates of Past Year Ecstasy/MDMA Use in the United States. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Acute psychological effects of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy") are attenuated by the serotonin uptake inhibitor citalopram. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

MDMA does not alter responses to the Trier Social Stress Test in humans. [2018]

14. Germany pubmed.ncbi.nlm.nih.gov

Changes in serotonin transporter (5-HTT) gene expression in peripheral blood cells after MDMA intake. [2018]