MDMA-Assisted Therapy for Narcissistic Personality Disorder

Overseen By Leslie Lazar Thorn

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Washington

Must not be taking: Antidepressants, Antipsychotics, Mood stabilizers, others

Disqualifiers: Bipolar, Psychotic disorder, Substance use, others

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

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

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This open-label, proof-of-concept pilot study will assess the efficacy and safety of midomafetamine (MDMA) - assisted therapy (AT) for participants diagnosed with pathological narcissism. As all participants will be allocated to a single group assignment, there will be no blinding, randomization, or comparator treatment. Participants will have a screening visit, a preparation period of 3 visits, a treatment period receiving MDMA-AT at 3 monthly visits, a 6 month follow up period coming in at one week, one month, three months and six months after last treatment visit.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. Participants must taper off all prohibited medications that could interact with MDMA, including psychoactive medications like antidepressants, before the third preparation session. You can only resume these medications after the study ends unless it's necessary for your health.

What data supports the effectiveness of the treatment MDMA-Assisted Therapy for Narcissistic Personality Disorder?

Research shows that MDMA-assisted therapy has been effective in treating posttraumatic stress disorder (PTSD), with significant improvements in symptoms compared to a placebo. Additionally, MDMA is known to enhance trust, empathy, and cooperative behavior, which could be beneficial in addressing interpersonal issues common in personality disorders. ^{1 2 3 4 5}

Is MDMA-assisted therapy generally safe for humans?

Research shows that MDMA-assisted therapy has been safely administered in clinical settings for conditions like PTSD and alcohol use disorder, with no serious adverse events reported. However, MDMA can have side effects, and its safety profile may vary depending on the specific condition and individual. ^{1 2 6 7 8}

How does MDMA-assisted therapy differ from other treatments for narcissistic personality disorder?

MDMA-assisted therapy is unique because it combines the drug MDMA with psychotherapy, potentially enhancing emotional openness and therapeutic relationships, which may be beneficial for conditions involving interpersonal dysfunction. This approach is different from standard treatments, as it uses MDMA to facilitate deeper emotional processing and connection during therapy sessions. ^{1 3 5 8 9}

Research Team

Alexa Albert, MD

Principal Investigator

University of Washington

Anthony Back, MD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for individuals diagnosed with Narcissistic Personality Disorder. Participants will undergo a screening, attend preparation visits, receive MDMA-assisted therapy during treatment visits, and have follow-ups over six months.

Inclusion Criteria

Must agree to safety lab assessments including a complete blood count and metabolic panel

I will report all my health conditions and any upcoming medical procedures.

Must agree to specific ECG assessments

Exclusion Criteria

I do not have uncontrolled high blood pressure or serious heart conditions.

Must not have current alcohol or substance use disorder

Must not have any current problems that may interfere with participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person), phone screen

Preparation

Medication tapering, three Preparation Sessions, Baseline assessments, Enrollment Confirmation

3 weeks

3 visits (in-person)

Treatment

Three monthly Experimental Sessions with MDMA-AT and nine associated Integration Sessions

12 weeks

3 visits (in-person) for Experimental Sessions, 9 visits (in-person) for Integration Sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

4 visits (in-person) at one week, one month, three months, and six months after last treatment

Treatment Details

Interventions

• MDMA-Assisted Therapy

Trial Overview The study tests the effectiveness and safety of midomafetamine (MDMA)-assisted therapy in treating pathological narcissism. It's an open-label pilot study without blinding or randomization, meaning everyone knows they're getting the treatment.

Participant Groups

Group I: Participant Experimental Treatment 1 Intervention

midomafetamine (MDMA)-assisted therapy

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

Approved in United States as MDMA for:

• None approved; Investigational New Drug application for pathological narcissism

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Findings from Research

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]

In a preliminary study of MDMA-assisted psychotherapy for alcohol use disorder, the first four participants tolerated the treatment well, with no serious adverse events or unexpected physiological responses observed during the 8-week course.

The results suggest that MDMA-assisted therapy is safe and tolerable, prompting plans to expand the research into a randomized placebo-controlled study to further evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First study of safety and tolerability of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary data on the first four participants. Sessa, B., Sakal, C., O'Brien, S., et al.[2021]

MDMA may enhance psychotherapy for social anxiety disorder by improving memory reconsolidation, which can help patients process and integrate their experiences more effectively.

The drug may also foster self-transcendent emotions like compassion and love, and strengthen the therapeutic relationship, both of which are crucial for successful treatment outcomes in disorders characterized by social disconnection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential processes of change in MDMA-Assisted therapy for social anxiety disorder: Enhanced memory reconsolidation, self-transcendence, and therapeutic relationships. Luoma, JB., Shahar, B., Kati Lear, M., et al.[2022]

In a study involving 25 participants, MDMA administration led to increased feelings of 'closeness to others' and 'euphoria', but did not significantly enhance empathy, trust, or cooperative behavior in various tasks.

Three days after MDMA administration, there were no significant changes in mood, indicating that while MDMA has acute subjective effects, it may not translate to measurable prosocial behavior or long-term mood improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of MDMA on trust, cooperative behaviour and empathy: A double-blind, placebo-controlled experiment. Borissova, A., Ferguson, B., Wall, MB., et al.[2022]

In a clinical trial involving 20 patients with chronic PTSD who had not responded to other treatments, those receiving MDMA during psychotherapy showed a significantly greater reduction in PTSD symptoms compared to the placebo group, with an 83% response rate in the MDMA group versus 25% in the placebo group.

MDMA-assisted psychotherapy was found to be safe, with no serious adverse events or negative effects on neurocognitive function, suggesting it could be a beneficial treatment option for patients with treatment-resistant PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Mithoefer, MC., Wagner, MT., Mithoefer, AT., et al.[2021]

Recent studies suggest that (±)-MDMA can be effective as an adjunct to psychotherapy for treating psychiatric disorders, but it also has a range of adverse effects that may limit its clinical use.

Preclinical research indicates that the R(-)-MDMA enantiomer may offer a better therapeutic profile than the racemic (±)-MDMA, potentially maintaining therapeutic benefits while reducing side effects, warranting further investigation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(±)-MDMA and its enantiomers: potential therapeutic advantages of R(-)-MDMA. Pitts, EG., Curry, DW., Hampshire, KN., et al.[2018]

MDMA, commonly known as ecstasy, is often mistakenly believed to be a safe drug, but its use has led to significant health risks, including serious cardiovascular effects and long-term neuropsychiatric issues.

The review highlights the increasing prevalence of ecstasy use among teenagers and young adults, emphasizing the need for awareness of its potential for toxicity and the importance of proper emergency care for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ecstasy toxicity]. Reingardiene, D.[2018]

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]

The BIMA study, involving 14 patients with alcohol use disorder, demonstrated that MDMA-assisted psychotherapy was well tolerated, with no unexpected adverse events reported during the treatment.

Participants showed significant improvement in alcohol consumption, reducing their average intake from 130.6 units per week before detox to 18.7 units per week nine months post-detox, suggesting potential efficacy for MDMA therapy in treating alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. Sessa, B., Higbed, L., O'Brien, S., et al.[2022]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

First study of safety and tolerability of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary data on the first four participants. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Potential processes of change in MDMA-Assisted therapy for social anxiety disorder: Enhanced memory reconsolidation, self-transcendence, and therapeutic relationships. [2022]

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

Acute effects of MDMA on trust, cooperative behaviour and empathy: A double-blind, placebo-controlled experiment. [2022]

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

The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

(±)-MDMA and its enantiomers: potential therapeutic advantages of R(-)-MDMA. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Ecstasy toxicity]. [2018]

8. 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]

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

First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. [2022]