MDMA-AT for PTSD in Young Adults With Childhood Trauma
ConditionPosttraumatic Stress Disorder (PTSD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-26
SponsorJenna M. Traynor
About this trial
This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT).
The main questions it aims to answer are:
* Is the treatment safe and feasible to administer? * Does the treatment improve PTSD symptoms?
Participants will be asked to:
* Complete screening procedures, including a medical and psychiatric evaluation to ensure safe participation * Attend up to three preparatory talk therapy sessions prior to the first MDMA-AT dosing session * Attend three integration talk therapy sessions after each MDMA-AT dosing session * Attend up to three total MDMA-AT dosing sessions * Complete assessments from baseline to 38-weeks post-baseline * Complete a fMRI scan at baseline and at 18-weeks post-treatment * Complete self-report measures and ecological momentary assessments (EMAs) across the study period
Eligibility criteria
Qualifiers
Between the ages of 18-26 years old upon signing the written consent form
Proficient in speaking and reading English.
Capable of providing informed consent.
Is able to swallow pills.
Disqualifiers
Recently attempted suicide or engaged in high risk self-injury or is otherwise assessed to be at imminent risk of suicide by study staff
In the opinion of the PI, would present a serious risk to others as established through study screening measures or clinical observations.
Meets DSM-5 criteria for any current substance use disorder, other than alcohol, cannabis, or nicotine use disorder
For cannabis use and alcohol use disorders without physiological dependence, must agree to be abstinent from alcohol and cannabis for one week prior to and following each MDMA-AT session.
Trial design
Treatments tested in this trial
- MDMA assisted psychotherapy
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Jenna M. Traynor
Lead sponsor
Mclean Hospital
Sponsor institution
Source ClinicalTrials.gov