Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel (NCT00402298) | Clinical Trial Compass
TerminatedPhase 2
Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel
Stopped: This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection.
Israel5 participantsStarted 2007-05-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of Posttraumatic stress disorder still remaining after at least one treatment, with treatment including psychotherapy or pharmacotherapy. At least two-thirds of participants will have PTSD as a result of war and terrorism
* May meet criteria for a mood disorder.
* Must be at least 18 years old.
* Must be able to stop taking psychiatric medication from the start of the study until the two-month follow-up.
* May continue seeing an outside therapist during the study, but cannot increase the length or frequency of treatments.
* Must be able to follow all the rules and instructions relating to the experimental session, including restrictions on food and substance (alcohol and drug) consumption
* Must be willing to stay overnight in the clinic after each experimental session until the non-drug session occurring the next morning.
* Must be willing to be contacted by one of the researchers on a daily basis for a week after each experimental session.
* If a woman of childbearing potential, must have a negative pregnancy test and must agree to use an effective form of birth control.
* Must be able to speak and read Hebrew.
Exclusion Criteria:
* Cannot have history of or be diagnosed with psychotic disorder or bipolar affective disorder - 1.
* Cannot be diagnosed with dissociative identity disorder, an eating disorder with active purging, or borderline personality disorder.
* Cannot have evidence or history of significant hematological, endocrine, cere…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-Month Follow-Up
Timeframe: Baseline to two months after second MDMA-assisted experimental session