This open-label trial (n=30) will test whether the MDMA-assisted psychotherapy protocol is also effective in treating PTSD incurred by healthcare workers during the Covid pandemic.
Just like in the other MAPS trials, this trial will consist of two dosing sessions with MDMA and about ten other non-drug therapy sessions of 90 minutes.
Country United States of America
Visit trial
Status
Not yet recruiting
Results Published
Start date
01 October 2022
End date
01 April 2025
Chance of happening
95%
Phase
Phase II
Design
Open
Type
Interventional
Generation
First
Participants
30
Sex
All
Age
18- 99
Therapy
Yes
Trial Details
This study aims to assess the safety and efficacy of MDMA-Assisted Therapy on Health Care Workers suffering from symptoms of Post-Traumatic Stress due to their work on the frontline of the COVID Pandemic. After being informed about the study and potential risks, screening participants who sign the Informed Consent form will go through multiple screening visits (onsite and remote) designed to assess psychiatric and medical appropriateness for the study treatment. Tapering of certain medications are required. The screening period takes between 3 to 7 weeks and includes two preparatory sessions (90 minutes each) with the participant's assigned therapy team. Once a screening participant is deemed eligible for the study, baseline measures of symptomatology are obtained and a third preparatory session is conducted. The participant then enters into the Active Treatment Period which begins with the first of two all-day dosing sessions followed by three 90-minute integration (non-drug) sessions scheduled approximately a week and a half apart. Approximately 3 to 5 weeks after the first dosing session, a second all-day dosing session takes place, followed again by three 90-minute integration (non-drug) sessions scheduled about a week and a half apart. The total time to complete the Active Treatment Phase is between 4 and 9 weeks. Two to four weeks after the Active Treatment Phase, participants will meet with therapy team for a Treatment Termination Visit during which participants will complete primary outcome measures. Six months later, participants will be contacted and asked to repeat study measures to assess durability of effects. From Screening to Treatment Termination, participation in the study takes between 9 and 27 weeks. Some non-drug sessions can be done remotely at the discretion of the therapy team.NCT Number NCT05455996
Sponsors & Collaborators
Nautilus SanctuaryNautilus Sanctuary is a study site in New York City, United States currently dedicated to groundbreaking Phase III research on MDMA-assisted therapy for PTSD, sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS).
MAPS
MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.
Measures Used
Clinician-Administered PTSD Scale for DSM-5The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is often considered the gold standard in PTSD assessment. The 30-item structured interview was developed by staff at the U.S. Department of Veterans Affairs National Centre for PTSD. CAPS can be used to make a current diagnosis, lifetime diagnosis or assess PTSD symptoms over the past week in accordance with DSM-5 criteria.