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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether MDMA-assisted therapy, a treatment using a drug known for its effects on mood and perception, is safe and effective for individuals with pathological narcissism, a personality disorder marked by an inflated sense of self-importance and need for admiration. All participants will receive the same treatment, with no comparison groups. Ideal candidates have been diagnosed with pathological narcissism and are already in therapy for this condition. Participants must be willing to follow all study requirements, including attending therapy and MDMA treatment sessions. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to contribute to groundbreaking insights.

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.

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

Research has shown that MDMA-assisted therapy is generally safe and well-tolerated. In one study with 12 patients, researchers reported no serious side effects, suggesting the treatment poses no major safety concerns. Another study on MDMA-assisted therapy for alcohol use disorder (AUD) found that participants accepted the treatment well without significant issues. This offers some reassurance about its safety for other conditions, such as narcissistic personality disorder. However, as this trial is in its early stages, further research is needed to confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard approaches for Narcissistic Personality Disorder, which often involve talk therapy and medications like antidepressants or mood stabilizers, MDMA-Assisted Therapy uses MDMA, a compound known for its empathogenic effects. Researchers are excited because MDMA may help patients process emotions and build empathy, potentially addressing core issues of the disorder more directly. This unique mechanism of facilitating emotional breakthroughs could lead to more profound and lasting changes compared to traditional treatments.

What evidence suggests that MDMA-Assisted Therapy might be an effective treatment for Narcissistic Personality Disorder?

Research suggests that therapy using MDMA, which participants in this trial will receive, might help treat narcissistic personality disorder. MDMA can increase openness and willingness to explore feelings, which is crucial for effective therapy. Early studies show that MDMA might reduce fear and boost self-confidence, facilitating therapy participation for those with narcissism. Although specific data on its effectiveness for narcissistic personality disorder remains limited, these early signs are promising and suggest that MDMA could enhance therapy outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Alexa Albert, MD

Principal Investigator

University of Washington

Anthony Back, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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

Must agree to specific ECG assessments

Must agree to specific rhythm strip assessments

Exclusion Criteria

Must not have current alcohol or substance use disorder

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

Must not have any current problems that may interfere with participation

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. depts.washington.edu depts.washington.edu/mdma-narcissism/wordpress/wp-content/uploads/2025/01/MDMA_Back-Albert_main_ICF_v3.4_2024Nov13.pdf

A Pilot Study of MDMA-Assisted Therapy for the Treatment ... We're doing this study to find out if a new kind of therapy can help people who have narcissism that is interfering with the quality of their ...

2. serenityprofessionalcounseling.com serenityprofessionalcounseling.com/breaking-the-narcissistic-shell-how-mdma-therapy-offers-new-hope-for-a-treatment-resistant-condition

Breaking the Narcissistic Shell: How MDMA Therapy Offers ... "Given preliminary evidence indicating that MDMA can bolster self-confidence, promote emotional openness, reduce fear responses, and increase ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12006724/

Psychoanalytically informed MDMA-assisted therapy for ... These findings suggest MDMA could help narcissistic patients engage more deeply in self-reflective processes necessary for therapeutic change.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06565494

MDMA-Assisted Therapy for Pathological Narcissism This open-label, proof-of-concept pilot study will assess the efficacy and safety of midomafetamine (MDMA) - assisted therapy (AT) for participants ...

5. withpower.com withpower.com/trial/early-phase-1-narcissism-7-2024-cf94f

MDMA-Assisted Therapy for Narcissistic Personality Disorder Trial Overview The study tests the effectiveness and safety of midomafetamine (MDMA)-assisted therapy in treating pathological narcissism. It's an open-label ...

6. depts.washington.edu depts.washington.edu/mdma-narcissism/wordpress/wp-content/uploads/2024/07/MDMA_Back-Albert_main_ICF_v2.4_16July2024.pdf

MDMA-Assisted Therapy for the Treatment of Narcissism We're doing this study to find out if a new kind of therapy can help people who have narcissism that is interfering with the quality of their ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424000802

Design and methodology of the first open-label trial ... Case data from the first study evaluating MDMA-AT study for AUD found the treatment was well tolerated and alcohol use was significantly reduced post treatment.