MDMA-Assisted Therapy for Pathological Narcissism

NCT06565494 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00020440
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Narcissism

Keywords

MDMA; Assisted Therapy; midomafetamine

Outcome Measures

Primary Outcomes (1)

• Pathological Narcissism Inventory (PNI)--Participant version

  Assess changes in diagnostic features of pathological narcissism per self-report. This measure has 52 items each rated on a 6-point Likert scale with higher scores indicating higher severity.

  Baseline, After each MDMA session (approx every month for 3 months); After MDMA sessions end, 1 month, 3 months, 6 months

Other Outcomes (2)

• Reported adverse events

  Baseline, After each MDMA session (approx every month for 3 months); After MDMA sessions end, 1 month, 3 months, 6 months

• Columbia Suicide Severity Rating Scale (C-SSRS)

  Baseline, After each MDMA session (approx every month for 3 months); After MDMA sessions end, 1 month, 3 months, 6 months

Study Arms (1)

Participant

EXPERIMENTAL

midomafetamine (MDMA)-assisted therapy

Drug: midomafetamine (MDMA)-Assisted Therapy

Interventions

midomafetamine (MDMA)-Assisted Therapy DRUG

This treatment consists 3 Preparation sessions followed by 3 Experimental sessions at 4-week intervals; after each Experimental session, 3 weekly Integration sessions will be conducted. For the first Experimental Session, the dose of MDMA is 80 mg; for the second and third Experimental Sessions, the dose of MDMA is 120 mg. For all three Experimental sessions, a supplemental dose of 50% of the initial dose will be available. The Preparation, Experimental, and Integration Sessions will involve psychotherapy developed specifically for this trial and population.

Participant

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Are at least 18 years old.
• Are between the ages of 18 years old and 64 years old.
• Weigh at least 48 kilograms (i.e., 106 pounds).
• If able to become pregnant, must have a negative over-the-counter (OTC) urine pregnancy test at the Screening Visit, at the last Preparation Session, and prior to each Experimental Session. They must agree to use adequate birth control from Enrollment Confirmation through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e., condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). "Not able to become pregnant" is defined as permanent sterilization, postmenopausal (defined as 12 months with no menses without an alternative medical cause), or assigned male at birth. All subjects who do not fall into the category of 'not able to become pregnant' will complete pregnancy tests immediately before every Experimental Dosing Session.
• If assigned male at birth, must agree to use barrier contraception if partner is of childbearing potential, and must agree to consider sperm donation if planning to conceive after completing study participation.
• Are proficient in speaking and reading English.
• Are able to give adequate informed consent.
• Are able to swallow pills.
• Must agree to safety lab assessments including a complete blood count and a metabolic panel inclusive of kidney and liver function tests.
• Must agree to a 1-minute rhythm strip at the Screening Visit to assess for heretofore undiagnosed arrhythmias.
• Must agree to commit to the midomafetamine (MDMA) dosing, Experimental Sessions, non-drug Preparation and Integration Sessions, Follow-up Visits to complete clinical measures at all four Follow-up endpoints, and all necessary telephone contact.
• Must select a family member (spouse/partner or relative) with whom they are willing to allow Study Staff to communicate and whom they consent to complete Informant-report assessments at Baseline (T0) and at all Follow-up endpoints (T1-T4). Contact information (cell phone \& email address) for their selected family member must be provided by participant at the Screening Visit. Participant's selected family member must consent to participate and provide written informed consent.
• Must be willing to sign a medical release for Study Staff to communicate directly with the participant's psychotherapist and consent to their completing Informant-report assessments at Baseline (T0) and at all Follow-up intervals (T1-T4). Contact information (business and/or cell phone) for their psychotherapist will be provided by participant at the Screening Visit. Participant's psychotherapist must consent to participate and provide written informed consent.
• Must provide a contact (spouse/partner, relative, close friend, or other caregiver) who is willing and able to be reached by Study Staff in the event of an emergency, if the participant becomes suicidal, or if the participant is unreachable.
• Must agree to inform the Study Staff within 48 hours if any medical conditions occur or medical procedures are planned.

You may not qualify if:

• Are not able to give adequate informed consent.
• Are less than 18 years old or 65 years or older.
• Have any current problem which in the opinion of the study investigators, study physician or Medical Monitor might interfere with participation including:
• Psychiatric Conditions
• Have a psychiatric diagnosis of bipolar disorder, psychotic disorder, anorexia nervosa or bulimia as assessed with the Mini International Neuropsychiatric Interview (MINI) at the Screening Visit.
• Have had active suicidal ideation and/or behaviors in Past 12 Months as assessed with the MINI at the Screening Visit. For those assessed to be at Moderate Risk or High Risk "likely in the near future" using the established MINI thresholds, participants' personal therapists will be contacted to assist in triage planning. If it is determined that the participant is at imminent risk of suicide and/or the personal therapist is unavailable, emergency services will be called for transfer to the nearest Emergency Department and "a "warm hand-off" will be made to a receiving provider there.
• Have a current alcohol or substance use disorder as assessed with the MINI at the Screening Visit.
• Have a co-occurring dissociative identity disorder diagnosis from their current clinically licensed psychotherapist.
• Have used MDMA within the last 12 months.
• Medical Conditions
• Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury \[mmHg\] or higher assessed on three separate occasions).
• Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease. Have a history of atrial flutter or any arrhythmia at any time, other than occasional PVCs in the absence of ischemic heart disease. Participants with a history of paroxysmal supraventricular tachycardia, paroxysmal atrial tachycardia, or atrial fibrillation arrhythmia may be enrolled if successfully treated with ablation cardioversion treatment at least 12 months prior and cleared by a cardiologist, the site physician, and Medical Monitor.
• Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
• Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds corrected by Bazett's formula).
• Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Links

• This website contains information for anyone who is interested in learning more or participating in the study.

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Anthony Back, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Alexa Albert, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine

Model Details: Open-Label, proof-of-concept with single group assignment.

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 22, 2024
• Study Start: August 27, 2024
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)