Posttraumatic Stress DisorderPhase 2NCT01458327
Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial
A Phase 2 study testing Midomafetamine and Therapy in people with Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals at 1 site in United States.
Trial 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. 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?
- Midomafetamine and Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2010to 27 Jun 2014
- 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
- Be diagnosed with chronic PTSD;
- Have a CAPS score showing moderate to severe PTSD symptoms;
- Have participated in MP-1;
- Are at least 18 years old;
- Must be generally healthy;
- Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
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- Are willing to refrain from taking any psychiatric medications during the study period;
- Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session;
- Willing to remain overnight at the study site;
- Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session;
- Are willing to be contacted via telephone for all necessary telephone contacts;
- Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control;
- must provide a contact in the event of a participant becoming suicidal;
- Are proficient in speaking and reading English;
- agree to have all clinic visit sessions recorded to audio and video
- Agree not to participate in any other interventional clinical trials during the duration of this study.
Who cannot join
- Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
- Weigh less than 48 kg;
- Are abusing illegal drugs;
- Are unable to give adequate informed consent;
- Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary;
- Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Offices of Michael Mithoefer
Mt. Pleasant, South Carolina, 29464
About this study
Official title: An Open-Label Proof-of-Principle Study Testing the Use of an Additional MDMA-Assisted Therapy Session in People Who Relapsed After Participating in a Phase 2 Clinical Trial of MDMA-Assisted Therapy to Treat Chronic, Treatment-Resistant Posttraumatic Stress Disorder
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.
Read the detailed description
This study will investigate the effects of an additional 3,4-methylenedioxymethamine (MDMA)-assisted therapy session in up to three participants with PTSD who relapsed after their PTSD symptoms had significantly decreased during MAPS' initial U.S. Phase 2 trial testing the use of MDMA-assisted therapy in subjects with chronic, treatment-resistant posttraumatic stress disorder PTSD). This new protocol will consist of a single, full-dose open-label session of MDMA-assisted therapy, along with associated non-drug preparation and integrative therapy sessions.
MDMA is an investigational drug that was studied in a randomized, placebo-controlled study in 21 participants, and it included a final evaluation of symptoms at least one year after taking part in the study. While PTSD symptoms in most study subjects stayed at the same levels from when they completed the study, symptoms had returned in a few people. This open-label study is intended to see if an additional MDMA-assisted session conducted at least 14 months after the first sessions can help reduce PTSD symptoms.
The MDMA-assisted therapy session will be conducted by a male and female co-therapist team, one a psychiatrist and the other a psychiatric nurse. Vital signs (blood pressure, pulse and body temperature) and psychological distress will be measured throughout the experimental session. After the experimental session they will spend the night in the clinic with an attendant on duty, and complete a measure of alterations in consciousness, the States of Consciousness Questionnaire (SCQ) on the evening or day following the experimental session. Participants will meet with the investigators the next morning for an integrative therapy session before leaving the clinic. During integrative therapy sessions they will receive support in integrating their experiences and insights from the MDMA-assisted therapy session. There will be daily phone contact with one of the investigators for 7 days after the experimental session. Symptoms of PTSD, depression and general function will be assessed two months after the experimental session. There will be a long-term follow up with repeated outcome measures 12 months after the experimental session
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Midomafetamine, Therapy
- Keywords
- MDMA, PTSD, therapy
- 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.
MidomafetamineDrug
Also called MDMA, 3,4-methylenedioxymethamphetamine
125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later
TherapyBehavioural
Non-directive therapy
| Study group | Role | What they receive |
|---|---|---|
| MDMA-assisted therapy | Experimental | One experimental session of MDMA-assisted therapy Receives: Drug: Midomafetamine; Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Measured: Less than 4 weeks before first experimental session
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month Follow-up
The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Measured: 2 months post experimental session
Clinician-Administered PTSD Scale (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. 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: 12 months post experimental session
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 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. 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 2 months post experimental session
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 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. 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 12 months post experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study start15 Dec 2010
- Primary completion27 Jun 2014
- Study completion27 Jun 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael C Mithoefer, MD, Principal investigator, Psychiatrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458327
- Sponsor's protocol ID
- MP1-E2
- Status last verified
- Jan 2024
- First submitted
- 12 Oct 2011
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Proof-of-Principle Study Testing the Use of an Additional MDMA-Assisted Therapy Session in People Who Relapsed After Participating in a Phase 2 Clinical Trial of MDMA-Assisted Therapy to Treat Chronic, Treatment-Resistant Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01458327
- Acronym / sponsor ID
- MP1-E2
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- MDMA, PTSD, therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2010 (actual)
- Primary completion
- 27 Jun 2014 (actual)
- Study completion
- 27 Jun 2014 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Posted 3 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will investigate the effects of an additional 3,4-methylenedioxymethamine (MDMA)-assisted therapy session in up to three participants with PTSD who relapsed after their PTSD symptoms had significantly decreased during MAPS' initial U.S. Phase 2 trial testing the use of MDMA-assisted therapy in subjects with chronic, treatment-resistant posttraumatic stress disorder PTSD). This new protocol will consist of a single, full-dose open-label session of MDMA-assisted therapy, along with associated non-drug preparation and integrative therapy sessions.
MDMA is an investigational drug that was studied in a randomized, placebo-controlled study in 21 participants, and it included a final evaluation of symptoms at least one year after taking part in the study. While PTSD symptoms in most study subjects stayed at the same levels from when they completed the study, symptoms had returned in a few people. This open-label study is intended to see if an additional MDMA-assisted session conducted at least 14 months after the first sessions can help reduce PTSD symptoms.
The MDMA-assisted therapy session will be conducted by a male and female co-therapist team, one a psychiatrist and the other a psychiatric nurse. Vital signs (blood pressure, pulse and body temperature) and psychological distress will be measured throughout the experimental session. After the experimental session they will spend the night in the clinic with an attendant on duty, and complete a measure of alterations in consciousness, the States of Consciousness Questionnaire (SCQ) on the evening or day following the experimental session. Participants will meet with the investigators the next morning for an integrative therapy session before leaving the clinic. During integrative therapy sessions they will receive support in integrating their experiences and insights from the MDMA-assisted therapy session. There will be daily phone contact with one of the investigators for 7 days after the experimental session. Symptoms of PTSD, depression and general function will be assessed two months after the experimental session. There will be a long-term follow up with repeated outcome measures 12 months after the experimental session
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDMA-assisted therapy | Experimental | Drug: Midomafetamine, Behavioral: TherapyOne experimental session of MDMA-assisted therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Be diagnosed with chronic PTSD;
- Have a CAPS score showing moderate to severe PTSD symptoms;
- Have participated in MP-1;
- Are at least 18 years old;
- Must be generally healthy;
Key exclusion criteria (6 listed)
- Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
- Weigh less than 48 kg;
- Are abusing illegal drugs;
- Are unable to give adequate informed consent;
- Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary;
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 |
|---|---|---|
| MidomafetamineAlso: MDMA, 3,4-methylenedioxymethamphetamine125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later | Drug | MDMA-assisted therapy |
| TherapyNon-directive therapy | Behavioural | MDMA-assisted therapy |
Primary outcome
Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
Time frame: Less than 4 weeks before first experimental session
The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month Follow-up
Time frame: 2 months post experimental session
The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Clinician-Administered PTSD Scale (CAPS-IV)) at 12-month Follow-up
Time frame: 12 months post 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. 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.
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up
Time frame: Baseline to 2 months post 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. 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.
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 12-month Follow-up
Time frame: Baseline to 12 months post 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. 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- 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.
Michael C Mithoefer, MD principal investigator
Psychiatrist
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 Midomafetamine and Therapy in people with Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals at 1 site in United States.
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 16 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jan 2024. 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 United States. 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 3 Nov 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?
Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) (time frame: Less than 4 weeks before first experimental session). The study lists 5 primary outcomes in all. 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 24 Jan 2024.