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

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 the drug in patients with PTSD.

Intervention / Treatment

  • Drug: MDMA
  • Drug: Niacin

Condition or Disease

  • Post Traumatic Stress Disorder

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 21 Years to 55 Years   (Adult)
Enrollment: 20 ()
Funded by: Other

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Clinical Trial Dates

Start date: Jul 20, 2022
Primary Completion: Dec 15, 2023
Completion Date: Dec 15, 2023
Study First Posted: Nov 26, 2018
Results First Posted: Aug 30, 2020
Last Updated: Feb 08, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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 the relationship between these MDMA-induced neural changes and the acute behavioral effects of the drug in patients with PTSD. In addition, the investigators will collect preliminary data on the MDMA effects on large-scale intrinsic functional connectivity using novel graph-based network analyses.

Specifically, the investigators will measure medial prefrontal cortex (mPFC) and amygdala activation in response to negative stimuli in patients with PTSD. The investigators hypothesize that MDMA will increase mPFC, but decrease amygdala, activation in response to negative stimuli.

The investigators will also explore the relationship between the MDMA-induced mPFC and amygdala activation, and performance on Ekman's Emotional Facial Expression task. This task is modulated by the mPFC and amygdala and as well as trauma severity in participants with PTSD. And finally, to explore the effects of MDMA on resting-state functional connectivity (rs-fcMRI) the investigators will use Coupled Intrinsic Connectivity Distribution (Coupled-ICD); an innovative, graph-based, fully data-driven approach that is particularly sensitive to paired rs-fcMRI data (e.g. pre/post-treatment).

Adult participants with PTSD will be recruited for a double-blind, placebo-controlled, within-subjects, crossover-dose neuroimaging study in which they will initially receive either a single dose of MDMA 1.5mg/kg or a placebo (niacin 250mg), with a crossover dose to follow. Doses will be separated by 2 weeks.

Eligibility Criteria

Sex: All
Minimum Age: 21
Maximum Age: 55

This clinical trial is recruiting

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More Details

NCT Number: NCT03752918
Other IDs: 2000020348
Study URL: https://ClinicalTrials.gov/show/NCT03752918
Last updated: Jun 16, 2022