Posttraumatic Stress DisorderPhase 2NCT00402298
Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel
A Phase 2 study testing Full Dose Midomafetamine HCl and Low Dose Midomafetamine HCl in people with Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Full Dose Midomafetamine HCl and Low Dose Midomafetamine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- 27 May 2007to 5 May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
- Cannot have uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.
- Cannot weigh less than 50 or more than 105 kg.
- Cannot have used "Ecstasy" more than five times during lifetime or in the past six months.
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- Cannot present a serious suicide risk or be likely to require hospitalization during the course of the study.
- Cannot require ongoing concomitant therapy with a psychotropic drug.
- Cannot meet DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days.
- Unable to give adequate consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MDMA-assisted Therapy in Twelve People With War and Terrorism-related Posttraumatic Stress Disorder (PTSD)
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.
Read the detailed description
This study will examine whether two six to eight-hour long sessions of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy scheduled two to four weeks apart are safe, and whether combining a fully therapeutic dose of MDMA with psychotherapy, compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms, with symptoms measured four times, once at baseline and again 2, 6, and 12 months after the second experimental session. People who received the active placebo dose of MDMA can then take part in an "open label" study continuation, with the participant receiving a fully active dose of MDMA on two more six to eight hour-long psychotherapy sessions. Open-label means that the participants and the researchers know that the participant will receive the fully active dose of MDMA. People who take part in the open label study continuation have their PTSD symptoms checked six and 12 months after the second open label MDMA-assisted session.
This study will look at MDMA-assisted therapy in 12 individuals aged 18 years or older, with PTSD symptoms not improving after trying at least one treatment. At least two-thirds of participants will have diagnosed PTSD arising from war or terrorism-related trauma. Eight of 12 participants will be assigned to receive the full dose of MDMA, and four will be assigned to receive a low or "active placebo" dose of MDMA during each of two experimental sessions. The fully active dose consists of an initial dose of 125 mg MDMA HCl and a supplemental dose of 62.5 mg given 2 to 2.5 hours later. The active placebo dose consists of an initial dose of 25 mg MDMA HCl and a supplemental dose of 12.5 mg.
The study will will include two sixty minute long introductory therapy sessions, two active placebo or fully active dose MDMA-assisted therapy sessions, a sixty to ninety minute long therapy session 24 hours after each experimental session, and one to two hour-long therapy sessions occurring weekly between the first and second experimental session, and between the second experimental session and the end of the study.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Full Dose Midomafetamine HCl, Low Dose Midomafetamine HCl
- Keywords
- PTSD, MDMA, therapy, Posttraumatic stress disorder, Israel
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Dose Midomafetamine HClDrug
Also called midomafetamine, 3,4-methylenedioxymethamphetamine, MDMA HCl, MDMA
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.
Low Dose Midomafetamine HClDrug
Also called midomafetamine, 3,4-methylenedioxymethamphetamine, MDMA HCl, MDMA
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.
| Study group | Role | What they receive |
|---|---|---|
| Full dose (125 mg) MDMA-assisted therapy | Experimental | Participants will receive an initial dose of 125 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 62.5 mg midomafetamine HCl during the course of two day-long therapy sessions. Receives: Drug: Full Dose Midomafetamine HCl |
| Active Comparator (25 mg) MDMA-assisted therapy | Active comparator | Participants will receive an initial dose of 25 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 12.5 mg midomafetamine HCl during the course of two day-long therapy sessions. Receives: Drug: Low Dose Midomafetamine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-Month Follow-Up
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Measured: Baseline to two months after second MDMA-assisted experimental session
Secondary outcomes (2)
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 6-Month Follow-Up
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Measured: Baseline to six months after second MDMA-assisted experimental session
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 12-month Follow-up
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Measured: Baseline to twelve months after second MDMA-assisted experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study start27 May 2007
- Primary completionMar 2009
- Study completion5 May 2010
Why it stopped: This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moshe Kotler, Principal investigator, Director of Psychiatry, Beer Yaakov Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402298
- Sponsor's protocol ID
- MP-3
- Status last verified
- May 2025
- First submitted
- 20 Nov 2006
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MDMA-assisted Therapy in Twelve People With War and Terrorism-related Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00402298
- Acronym / sponsor ID
- MP-3
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, MDMA, therapy, Posttraumatic stress disorder, Israel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 May 2007 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- 5 May 2010 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Posted 20 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will examine whether two six to eight-hour long sessions of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy scheduled two to four weeks apart are safe, and whether combining a fully therapeutic dose of MDMA with psychotherapy, compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms, with symptoms measured four times, once at baseline and again 2, 6, and 12 months after the second experimental session. People who received the active placebo dose of MDMA can then take part in an "open label" study continuation, with the participant receiving a fully active dose of MDMA on two more six to eight hour-long psychotherapy sessions. Open-label means that the participants and the researchers know that the participant will receive the fully active dose of MDMA. People who take part in the open label study continuation have their PTSD symptoms checked six and 12 months after the second open label MDMA-assisted session.
This study will look at MDMA-assisted therapy in 12 individuals aged 18 years or older, with PTSD symptoms not improving after trying at least one treatment. At least two-thirds of participants will have diagnosed PTSD arising from war or terrorism-related trauma. Eight of 12 participants will be assigned to receive the full dose of MDMA, and four will be assigned to receive a low or "active placebo" dose of MDMA during each of two experimental sessions. The fully active dose consists of an initial dose of 125 mg MDMA HCl and a supplemental dose of 62.5 mg given 2 to 2.5 hours later. The active placebo dose consists of an initial dose of 25 mg MDMA HCl and a supplemental dose of 12.5 mg.
The study will will include two sixty minute long introductory therapy sessions, two active placebo or fully active dose MDMA-assisted therapy sessions, a sixty to ninety minute long therapy session 24 hours after each experimental session, and one to two hour-long therapy sessions occurring weekly between the first and second experimental session, and between the second experimental session and the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full dose (125 mg) MDMA-assisted therapy | Experimental | Drug: Full Dose Midomafetamine HClParticipants will receive an initial dose of 125 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 62.5 mg midomafetamine HCl during the course of two day-long therapy sessions. |
| Active Comparator (25 mg) MDMA-assisted therapy | Active comparator | Drug: Low Dose Midomafetamine HClParticipants will receive an initial dose of 25 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 12.5 mg midomafetamine HCl during the course of two day-long therapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
- Cannot have uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.
- Cannot weigh less than 50 or more than 105 kg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Dose Midomafetamine HClAlso: midomafetamine, 3,4-methylenedioxymethamphetamine, MDMA HCl, MDMAParticipants 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 | Full dose (125 mg) MDMA-assisted therapy |
| Low Dose Midomafetamine HClAlso: midomafetamine, 3,4-methylenedioxymethamphetamine, MDMA HCl, MDMAParticipants 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. | Drug | Active Comparator (25 mg) MDMA-assisted therapy |
Primary outcome
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-Month Follow-Up
Time frame: Baseline to two months after second MDMA-assisted experimental session
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
2 secondary outcomes
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 6-Month Follow-Up
Time frame: Baseline to six months after second MDMA-assisted experimental session
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 12-month Follow-up
Time frame: Baseline to twelve months after second MDMA-assisted experimental session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Kotler principal investigator
Director of Psychiatry, Beer Yaakov Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Full Dose Midomafetamine HCl and Low Dose Midomafetamine HCl in people with Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-Month Follow-Up (time frame: Baseline to two months after second MDMA-assisted experimental session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.