Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT06565494
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2024-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MDMA-Assisted Therapy for Pathological Narcissism
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
A Pilot Study of Midomafetamine (MDMA-Assisted) Therapy for the Treatment of Pathological Narcissism
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
This open-label, proof-of-concept pilot study will assess the efficacy and safety of midomafetamine- assisted therapy (MDMA-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.
Up to 12 participants will be enrolled. Each participant will have 2 informants, one family member and one psychotherapist.
The visit schedule for each participant will be comprised of the following:
* Screening Period: phone screen, visit screen, informed consent, eligibility assessment, and enrollment invitation to eligible participants;
* Preparation Period: medication tapering, three Preparation Sessions, Baseline assessments, Enrollment Confirmation;
* Treatment Period: three monthly Experimental Sessions and nine associated Integration Sessions over \~12 weeks;
* Follow-up Period and Study Termination: four Follow-up Visits at one week, one month, three months and six months after the final Integration Session to collect clinical outcome measures; Study Termination will happen at the last Follow-up Visit.
The treatment (MDMA-AT) 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.
Up to 12 participants will be enrolled. Each participant will have 2 informants, one family member and one psychotherapist.
The visit schedule for each participant will be comprised of the following:
* Screening Period: phone screen, visit screen, informed consent, eligibility assessment, and enrollment invitation to eligible participants;
* Preparation Period: medication tapering, three Preparation Sessions, Baseline assessments, Enrollment Confirmation;
* Treatment Period: three monthly Experimental Sessions and nine associated Integration Sessions over \~12 weeks;
* Follow-up Period and Study Termination: four Follow-up Visits at one week, one month, three months and six months after the final Integration Session to collect clinical outcome measures; Study Termination will happen at the last Follow-up Visit.
The treatment (MDMA-AT) 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: