MedTrace Logo

Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel

NCT00402298 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-06-05

Study results available
· View outcomes & findings →

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy can treat PTSD in participants with PTSD. Researchers will compare two sessions of MDMA-assisted therapy with two sessions of low dose (active placebo) MDMA-assisted therapy to determine if MDMA-assisted therapy is safe and works to treat PTSD symptoms.

Participants will be randomly assigned to receive either the full dose of MDMA or low active placebo dose of MDMA during each of two experimental sessions. PTSD symptoms will be measured throughout the study.

Conditions

Interventions

DRUG

Full Dose Midomafetamine HCl

Participants will receive an initial dose of 125 mg midomafetamine HCl orally followed 2.5 hours later by 62.5 mg midomafetamine HCl orally during the course of a day-long therapy session.

DRUG

Low Dose Midomafetamine HCl

Participants will receive an initial dose of 25 mg midomafetamine HCl orally followed 2.5 hours later by a supplemental dose of 12.5 mg midomafetamine HCl orally during the course of each of two day-long therapy sessions.

Sponsors & Collaborators

Principal Investigators

  • Moshe Kotler · Director of Psychiatry, Beer Yaakov Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-27
Primary Completion
2009-03-31
Completion
2010-05-05

Countries

  • Israel

Study Locations

More Related Trials

Entities

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 NCT00402298 on ClinicalTrials.gov