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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03752918
Study type	Interventional
Source	Yale University
Contact
Status	Withdrawn
Phase	Phase 1
Start date	May 2024
Completion date	January 2028

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05915013` - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response	Phase 1
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Recruiting	`NCT05934162` - Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD	N/A
Recruiting	`NCT05934175` - Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder	N/A
Completed	`NCT04460014` - Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT	N/A
Completed	`NCT05877807` - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Active, not recruiting	`NCT05992649` - The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 40-week Pilotproject	N/A
Terminated	`NCT04404712` - FAAH Availability in Psychiatric Disorders: A PET Study	Early Phase 1
Not yet recruiting	`NCT05331534` - Effect of Attentional Therapy on Post-traumatic Stress Disorder	N/A
Not yet recruiting	`NCT03649607` - Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black	N/A
Not yet recruiting	`NCT04076215` - Biochemical and Physiological Response to Stressogenic Stimuli	N/A
Not yet recruiting	`NCT02545192` - A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments	Phase 1
Completed	`NCT02329418` - Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit	N/A
Active, not recruiting	`NCT00978484` - A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder	Phase 3
Completed	`NCT00760734` - Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)	Phase 1
Completed	`NCT03278171` - Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit
Recruiting	`NCT05874362` - People Bereaved by Violent Death : Negative Event Biases and Temporal Perception	N/A
Terminated	`NCT03898843` - Assisted Animal Therapy: ReAnimal	N/A
Recruiting	`NCT04747379` - Psychological Effect of Explicit Recall After Sedation (PEERS)
Completed	`NCT03248167` - Cannabidiol as a Treatment for AUD Comorbid With PTSD	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms