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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

No Placebo-Only Group

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.