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Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD

NCT02102802 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2024-11-05

No results posted yet for this study

Summary

The goal of this observational sub-study is to provide information on how MDMA-assisted therapy affects the brain and body of people with chronic PTSD.

The main question it aims to answer is: Is PTSD symptom reduction associated with changes in heart rate variability and brain activity?

Participants from the MP-8 study will be invited to enroll in this sub-study where they will undergo an fMRI brain scan and other measurements of body function.

Conditions

Interventions

DRUG

Midomafetamine

125, 75, or 30 mg midomafetamine HCl followed 1.5 to 2 hours later by a supplemental dose of midomafetamine HCl half the initial dose

BEHAVIORAL

Therapy

Manualized therapy

Sponsors & Collaborators

Principal Investigators

  • Michael C Mithoefer, MD · Private Practice

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-08-03
Completion
2015-08-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02102802 on ClinicalTrials.gov