The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD.

• Status: Recruiting
• Trial end date: 2023-12-15
• Target enrollment: 0
• Participant gender: All

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 the drug in patients with PTSD.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: N-Methyl-3,4-methylenedioxyamphetamine; Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.