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Behavioural Intervention

MDMA-Assisted Therapy for Narcissistic Personality Disorder

Phase < 1

Recruiting

Led By Alexa Albert, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be at least 18 years old but no older than 64 years old

Must be able to swallow pills

Must not have

Must not have uncontrolled hypertension, certain arrhythmias, prolonged QT/QTc interval, or other cardiac conditions

Must be less than 18 years old or 65 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after each mdma session (approx every month for 3 months); after mdma sessions end, 1 month, 3 months, 6 months

Awards & highlights

Summary

This trial will test the effectiveness and safety of using MDMA-assisted therapy for individuals diagnosed with pathological narcissism. All participants will receive the same treatment without any blinding or randomization. The study involves

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects of MDMA can include anxiety, insomnia, nausea, increased heart rate and blood pressure, jaw clenching or teeth grinding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old.

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I can swallow pills.

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I can attend sessions by myself.

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I weigh at least 106 pounds.

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I will continue my current psychotherapy during the treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am either under 18 or 65 years old or older.

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I weigh less than 48 kilograms.

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I have not had thoughts or actions of suicide in the last year.

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I do not have severe liver issues, low sodium, high fever, or conditions worsened by stimulant drugs.

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I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after each mdma session (approx every month for 3 months); after mdma sessions end, 1 month, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after each mdma session (approx every month for 3 months); after mdma sessions end, 1 month, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after each mdma session (approx every month for 3 months); after mdma sessions end, 1 month, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological Narcissism Inventory (PNI)--Participant version

Other study objectives

Columbia Suicide Severity Rating Scale (C-SSRS)

Reported adverse events

Side effects data

From 2020 Phase 3 trial • 100 Patients • NCT03537014

72%

Headache

61%

Muscle Tightness

52%

Decreased Appetite

46%

Suicidal Ideation

43%

Insomnia

33%

Anxiety

30%

Fatigue

30%

Nausea

26%

Viral Upper Respiratory Tract Infection

22%

Hyperhidrosis

20%

Dizziness

20%

Feeling Cold

15%

Nightmare

15%

Restlnessness

15%

Mydriasis

15%

Asthenia

13%

Nystagmus

13%

Bruxism

13%

Tremor

13%

Dizziness Postural

13%

Abdominal Discomfort

11%

Paraesthesia

11%

Depressed Mood

11%

Blood Pressure Increased

11%

Abdominal Pain Upper

11%

Dry Mouth

11%

Feeling Jittery

11%

Upper Respiratory Tract Infection

11%

Back Pain

Stress

Pollakiuria

Pain

Intrusive Thoughts

Disturbance in Attention

Musculoskeletal Pain

Depression

Arthralgia

Feeling of Body Temperature Change

Vomiting

Vision Blurred

Feeling Hot

Palpitations

Non-Cardiac Chest Pain

Temperature Intolerence

Muscle Spasms

Hypoaesthesia

Anger

Micturition Urgency

Substance Use

Flashback

Nervousness

Somnolence

Pain in Jaw

Pyrexia

Muscle Twitching

Feeling Abnormal

Ear Pain

Myalgia

Vertigo

Influenza

Dysmenorrhoea

Chills

Neck Pain

Oropharyngeal Pain

Emotional Disorder

Irritability

Agitation

Influenza Like Illness

Emotional Distress

Dissociation

Panic Attack

Diarrhea

Intentional Self-Injury

100%

80%

60%

40%

20%

Study treatment Arm

Placebo With Therapy

MDMA-assisted Therapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: ParticipantExperimental Treatment1 Intervention

midomafetamine (MDMA)-assisted therapy

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,791 Previous Clinical Trials

1,905,494 Total Patients Enrolled

Alexa Albert, MDPrincipal InvestigatorUniversity of Washington

Anthony Back, MDPrincipal InvestigatorUniversity of Washington

1 Previous Clinical Trials

30 Total Patients Enrolled

~8 spots leftby Aug 2026

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