CompletedN/AMDMA
Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD
Sponsored by Lykos Therapeutics
NCT ID
NCT02102802
Target Enrollment
10 participants
Start Date
2014-01
Est. Completion
2015-08-03
About This Study
The goal of this observational sub-study is to provide information on how MDMA-assisted therapy affects the brain and body of people with chronic PTSD. The main question it aims to answer is: Is PTSD symptom reduction associated with changes in heart rate variability and brain activity? Participants from the MP-8 study will be invited to enroll in this sub-study where they will undergo an fMRI brain scan and other measurements of body function.
Conditions Studied
Interventions
- •Midomafetamine
- •Therapy
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Enrolled in the parent study, "A Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans, Firefighters, and Police Officers with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)." NCT #: NCT01211405 Exclusion Criteria: * Mass brain lesion * Have metal in their skulls, * Having brain or heart pacemakers * History of major head trauma * Have past or present panic or extreme discomfort with being in small enclosed spaces (claustrophobia)
Study Locations (1)
Offices of Michael Mithoefer
Mt. Pleasant, South Carolina, United States