Finding studies
Finding studies
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Lead
University of Washington
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.
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
