Post Traumatic Stress DisorderEAMP1NCT04438512
A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD
A study testing Midomafetamine and Psychotherapy in people with Post Traumatic Stress Disorder, run by Resilient Pharmaceuticals at 2 sites in United States.
Trial summary
The goal of this expanded access protocol is to provide access to MDMA-assisted therapy for eligible patients with treatment-resistant PTSD who are not able to enroll in another MDMA-assisted therapy clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Midomafetamine and Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- At Screening, meet criteria for PTSD diagnosis according to medical history and clinical interview and have at least moderate PTSD symptoms in the last month.
- Have had at least two unsuccessful attempts at treatment for PTSD. Treatment attempts can consist of adequate dose and duration of medication treatment (at least 3 months of Paroxetine or Sertraline or other SSRI at dosages recommended in the package insert) or adequate duration of therapy treatment (at least 12 sessions of psychotherapy) or any combination of these two categories.
- Are at least 18 years old.
- Are fluent in speaking and reading a recognized language of the expanded access site.
- Are able to swallow pills.
- Agree to have study visits recorded, if applicable, including Experimental Sessions and non-drug therapy sessions.
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- Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a patient becoming suicidal or unreachable.
- Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
- If a patient has the ability to become pregnant, they must have a negative pregnancy test at program entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the protocol without prior approval of the medical monitor, remain overnight at the site, or nearby location, after each Experimental Session and be driven home on the following day, and commit to medication dosing, therapy, and program procedures.
- May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening within the past year to rule out underlying cardiovascular disease.
- May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
- May have current alcohol or substance use disorder if patient meets criteria for early remission prior to enrollment.
- May have a history of or current Diabetes Mellitus (Type 1 or Type 2), if the patient passes additional screening to rule out underlying cardiovascular disease
- May have hypothyroidism if taking adequate and stable thyroid replacement medication.
- May have a history of, or current glaucoma, if approval for program participation is received from an ophthalmologist.
Who cannot join
- Are not able to give adequate informed consent.
- Have any current problem which, in the opinion of the investigator or medical monitor, might interfere with participation.
- Have used Ecstasy (material represented as containing MDMA) within three months of the first Experimental Session; or have previously participated in a MAPS-sponsored MDMA clinical trial.
- In the investigator's opinion, lack a stable living situation or supportive family/network.
- Have evidence or history of significant medical and psychiatric disorders.
- Any patient presenting current serious suicide risk.
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- Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
- Have evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA.
- Have a history of ventricular arrhythmia, other than occasional PVCs in the absence of ischemic heart disease, at any time or with a history of supraventricular arrhythmia within the past year.
- Have a diagnosis of uncontrolled hypertension using the standard criteria of the American Heart Association for Stage 2 hypertension (values of 140/90 milligrams of Mercury [mmHg] or higher assessed on three separate occasions).
- Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] in males or >460 ms in females corrected by Fridericia's formula).
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions.
- Have symptomatic liver disease or have significant liver enzyme elevation.
- Have a history of HCV that has not been evaluated and treated successfully if treatment is indicated.
- Have history of hyponatremia or hyperthermia.
- Are pregnant or nursing, or able to become pregnant and are not practicing an effective means of contraception.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sunstone Medical, PC
Rockville, Maryland, 20850
Pearl Psychedelic Institute
Waynesville, North Carolina, 28786
About this study
Official title: An Intermediate-size Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD
The goal of this expanded access protocol is to provide access to MDMA-assisted therapy for eligible patients with treatment-resistant PTSD who are not able to enroll in another MDMA-assisted therapy clinical trial.
Participants will undergo three non-drug preparatory therapy sessions followed by three MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by three non-drug integrative therapy sessions.
Read the detailed description
This is an open-label, expanded access protocol for eligible patients with treatment-resistant PTSD. This protocol is designed to provide access to MDMA-assisted therapy for patients who are not eligible for participation in another ongoing MDMA-assisted therapy clinical trial. In addition, this program will provide supportive data on safety and tolerability of MDMA-assisted therapy in treatment-resistant patients with PTSD. The study will treat up to 50 patients.
A flexible dose of MDMA (80 to 120 mg midomafetamine HCl), followed by a supplemental dose unless contraindicated, is administered during the Treatment Period with manualized therapy in up to three open-label Experimental Sessions. During the Treatment Period, each Experimental Session is preceded by three 90-minute Preparatory Sessions and followed by three 90-minute Integrative Sessions of non-drug therapy. Experimental Sessions will be followed by an overnight stay.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Midomafetamine, Psychotherapy
- 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 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine HCl
Administration of 80 or 120 mg midomafetamine HCl in combination with manualized therapy and a supplemental dose 1.5 to 2 hrs later of 40 or 60 mg midomafetamine HCl, respectively
PsychotherapyBehavioural
Manualized therapy performed by therapist team
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manish Agrawal, MD, Principal investigator, Sunstone Medical, PCCaroline Lewis, MD, Principal investigator, Pearl Psychedelic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438512
- Sponsor's protocol ID
- EA
- Acronym
- EAMP1
- Status last verified
- Nov 2024
- First submitted
- 25 Feb 2020
- Last updated
- 5 Nov 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intermediate-size Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD
- ClinicalTrials.gov ID
- NCT04438512
- Acronym / sponsor ID
- EAMP1 / EA
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
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 expanded access protocol is to provide access to MDMA-assisted therapy for eligible patients with treatment-resistant PTSD who are not able to enroll in another MDMA-assisted therapy clinical trial.
Participants will undergo three non-drug preparatory therapy sessions followed by three MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by three non-drug integrative therapy sessions.
Detailed description
This is an open-label, expanded access protocol for eligible patients with treatment-resistant PTSD. This protocol is designed to provide access to MDMA-assisted therapy for patients who are not eligible for participation in another ongoing MDMA-assisted therapy clinical trial. In addition, this program will provide supportive data on safety and tolerability of MDMA-assisted therapy in treatment-resistant patients with PTSD. The study will treat up to 50 patients.
A flexible dose of MDMA (80 to 120 mg midomafetamine HCl), followed by a supplemental dose unless contraindicated, is administered during the Treatment Period with manualized therapy in up to three open-label Experimental Sessions. During the Treatment Period, each Experimental Session is preceded by three 90-minute Preparatory Sessions and followed by three 90-minute Integrative Sessions of non-drug therapy. Experimental Sessions will be followed by an overnight stay.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- At Screening, meet criteria for PTSD diagnosis according to medical history and clinical interview and have at least moderate PTSD symptoms in the last month.
- Have had at least two unsuccessful attempts at treatment for PTSD. Treatment attempts can consist of adequate dose and duration of medication treatment (at least 3 months of Paroxetine or Sertraline or other SSRI at dosages recommended in the package insert) or adequate duration of therapy treatment (at least 12 sessions of psychotherapy) or any combination of these two categories.
- Are at least 18 years old.
- Are fluent in speaking and reading a recognized language of the expanded access site.
- Are able to swallow pills.
Key exclusion criteria (17 listed)
- Are not able to give adequate informed consent.
- Have any current problem which, in the opinion of the investigator or medical monitor, might interfere with participation.
- Have used Ecstasy (material represented as containing MDMA) within three months of the first Experimental Session; or have previously participated in a MAPS-sponsored MDMA clinical trial.
- In the investigator's opinion, lack a stable living situation or supportive family/network.
- Have evidence or history of significant medical and psychiatric disorders.
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: 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine HClAdministration of 80 or 120 mg midomafetamine HCl in combination with manualized therapy and a supplemental dose 1.5 to 2 hrs later of 40 or 60 mg midomafetamine HCl, respectively | Drug | – |
| PsychotherapyManualized therapy performed by therapist team | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
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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.
Manish Agrawal, MD principal investigator
Sunstone Medical, PC
Caroline Lewis, MD principal investigator
Pearl Psychedelic Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midomafetamine and Psychotherapy in people with Post Traumatic Stress Disorder, run by Resilient Pharmaceuticals at 2 sites 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 17 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: status not confirmed, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
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.
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 Nov 2024.