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Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial

NCT01458327 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-01-24

Study results available
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Summary

This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.

Conditions

Interventions

DRUG

Midomafetamine

125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later

BEHAVIORAL

Therapy

Non-directive therapy

Sponsors & Collaborators

Principal Investigators

  • Michael C Mithoefer, MD · Psychiatrist

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-15
Primary Completion
2014-06-27
Completion
2014-06-27

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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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 NCT01458327 on ClinicalTrials.gov