The Effects of MDMA on Prefrontal and Amygdala... — Clinical Trial Details

This double-blind, randomised, within-subject crossover study uses HCP-style task and resting-state fMRI to determine the effects of MDMA on medial prefrontal cortex and amygdala activation in adults with PTSD.

Investigators hypothesise MDMA will increase mPFC and decrease amygdala responses to negative stimuli, and will relate these neural changes to performance on Ekman’s Emotional Facial Expression task and trauma severity.

Resting-state effects will be explored with Coupled Intrinsic Connectivity Distribution (Coupled-ICD) analyses. Participants receive single oral MDMA 1.5 mg/kg or niacin 250 mg with a 2-week washout before crossover; acute neural and behavioural responses plus preliminary connectivity data are collected.

Participants

Ages

21 – 55

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Inclusion Criteria:
Males or females between the ages of 21-55 years. Females included if not pregnant and agree to utilize a medically (non-hormonal) accepted birth control method (implant, condom, diaphragm with spermicide, IUD, tubal ligation, abstinence, or partner vasectomy) or if post-menopausal for ≥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 CAPS-5.
Score ≥23 on CAPS-5 at screening.
No more than mild TBI per modified Brief TBI Screen.
No medical/neurological problem or medication that would render MDMA unsafe by history or evaluation.
No prior exposure to MDMA.
Willing to remain overnight at study site after each experimental session and be driven home the day after sessions.
Not currently taking any listed excluded medications.
Willing to sign medical release for investigators to communicate with therapist/doctors.
Willing to abstain from alcohol, street drugs, and tobacco while in the study.

Exclusion Criteria

Exclusion Criteria:
Diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or current psychotic features per MINI 7.0.
Serious suicide or homicide risk as assessed by evaluating clinician.
Substance abuse or dependence in the 6 months prior to screening or positive pre-study urine drug screen.
Any significant history of serious medical or neurological illness.
Signs of major medical or neurological illness on exam or ECG/lab screening (e.g., positive urine tox, positive HIV tests).
Abnormality on physical exam unless study physician deems it safe to include.
Pregnant or lactating women or positive urine pregnancy test for women of child-bearing potential at screening or prior to imaging day.
Any history indicating learning disability, intellectual disability, or ADHD.
Family history of cardiovascular diseases; history of hypertension with baseline BP >140/90 mmHg; any history of syncope or baseline BP <100 mmHg systolic.
History of claustrophobia.
BMI > 30 kg/m2 or >250 pounds.
Use of anxiolytic, neuroleptic and SRI medications (off SRIs for 4 weeks, fluoxetine 5 weeks).
Females taking hormonal contraceptives are excluded.
Any metal or electromagnetic implants (pacemaker, artificial heart valve, defibrillator, aneurysm clip, cochlear implants, shrapnel, neurostimulators), significant sensory impairment, history of seizures or current anticonvulsant use.

Company

Product

Legal

The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Study Arms & Interventions

MDMA

Interventions

Niacin

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators