Status:
WITHDRAWN
The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD.
Lead Sponsor:
Yale University
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief Summary
This study aims to investigate the effects of MDMA on prefrontal and amygdala activation, and to explore the relationship between these MDMA-induced neural changes and the acute behavioral effects of ...
Detailed Description
The investigators intend to utilize state-of-the-art validated Human Connectome Project (HCP) style approaches to determine the effects of MDMA on prefrontal and amygdala activation, and to explore th...
Eligibility Criteria
Inclusion
- Males or females between the ages of 21-55 years. Females will be included if they are not pregnant and agreed to utilize a medically (non-hormonal)\* accepted birth control method (to include implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy) or if post-menopausal for at least 1 year, or surgically sterile.
- Able to provide written informed consent according to Yale HIC guidelines.
- Able to read and write English as a primary language.
- Diagnosis of PTSD, as determined by the Clinician Administered PTSD Scale (CAPS-5).
- Must have a score of 23 or higher on the Clinician-Administered PTSD Scale (CAPS-5) at screening.
- No more than mild TBI according to a modified version of the Brief TBI Screen.
- Must not have a medical/neurological problem or use medication that would render MDMA unsafe by history or medical evaluation.
- No prior exposure to MDMA.
- Are willing to remain overnight at the study site after each experimental session.
- Are willing to be driven home the day after the experimental sessions.
- Not currently taking any of the listed medications at the time of the study.
- Are willing to sign a medical release for the investigators to communicate directly with their therapist and doctors.
- Are willing to abstain from alcohol, street drugs, and tobacco products while in the study.
Exclusion
- Patients with a diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as determined by the MINI 7.0 for the DSM-5.
- Serious suicide or homicide risk, as assessed by evaluating clinician.
- Substance abuse or dependence during the 6 months prior to screening; or a positive pre-study (screening) urine drug screen.
- Any significant history of serious medical or neurological illness.
- Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory tests (e.g. positive urine tox, positive HIV/AIDS tests ).
- Abnormality on physical examination. A participant with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
- Pregnant or lactating women or a positive urine pregnancy test for women of child-bearing potential at screening or prior to any imaging day.
- Any history indicating learning disability, mental retardation, or attention deficit disorder.
- Family history of cardiovascular diseases. History of hypertension with baseline blood pressure above 140 mmHg (systolic) and over 90 mmHg (diastolic). Any history of syncope and/or baseline blood pressure below 100mmHg (systolic).
- History of claustrophobia.
- BMI \> 30 kg/m2 or \>250 pounds.
- Anxiolytic, neuroleptic and SRI medications (off SRIs for 4 weeks, fluoxetine 5 weeks).
- Females taking hormonal contraceptives will not be able to participate in the study \*(Hormonal contraceptives are exclusionary because MDMA increases production of oxytocin which is heavily modulated by other hormones (e.g. estrogen). Therefore, women need to be naturally cycling/ovulating and not taking any hormonal medications to participate in this study).
- Any metal or electromagnetic implants, including: (Cardiac pacemaker, artificial heart valve, defibrillator, aneurysm clip, cochlear implants, shrapnel, neurostimulators, history of metal fragments in eyes or skin, significant hearing loss or other severe sensory impairment, a history of seizures or current use of anticonvulsants.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03752918
Start Date
May 1 2024
End Date
January 1 2028
Last Update
May 17 2024
Active Locations (1)
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1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519