What is Expanded Access?
Expanded Access is a US Food and Drug Administration (FDA) program. “Expanded access, sometimes called ‘compassionate use,’ is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA).” https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/defa ult.htm
The FDA must determine if patients to be treated in Expanded Access have a serious or immediately life-threatening disease or condition. The Code of Federal Regulations (21 CFR Part 312.300) details how expanded access can be granted and what steps the FDA needs to follow.
The FDA must also determine that:
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat
• the disease or condition.
• The patient cannot obtain the drug under another IND or protocol.
• The potential patient benefit justifies the potential risks of the treatment use and those
• potential risks are not unreasonable in the context of the disease or condition to be
• Providing the investigational drug will not interfere with the initiation, conduct, or
• completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.
Where can I learn more about MDMA?
To learn more about MDMA, its use in clinical research, published data, pharmaceutical properties, safety profile, and history, please read the MAPS Investigator’s Brochure. The following is a paraphrased excerpt from pages 8 and 9 of the MAPS Investigator’s Brochure, 10th edition:
MDMA is a ring-substituted phenethylamine, also known as 3,4-methylenedioxy-N-methylamphetamine and N-methyl-3,4- methylenedioxyamphetamine. MDMA’s chemical formula is C11H15NO2. MDMA is structurally similar, but functionally distinct, from amphetamines. MDMA is a chiral molecule, MAPS uses racemic MDMA in the form of white crystalline powder compounded with inert material into capsules. The hydrochloride salt of MDMA is readily water soluble and once ionized is lipophilic. A substantial amount of data, both clinical and nonclinical, has been collected for over half a century of research on the physiological and psychological effects of MDMA in humans and animals. Estimates from animal data suggest a median lethal dose (LD50) in humans between 10 to 20 mg/kg. Due to a wide range of responses to identical milligram per kilogram (mg/kg) dosing, MAPS’ human trials use fixed doses equivalent to between 1 and 4 mg/kg (active doses in studies range from 75 mg to 225 mg). Onset of MDMA effects occurs 30 to 60 minutes after oral administration, peak effects appear 75 to 120 minutes post-drug, and duration of effects lasts from 3 to 6 hours, with most effects returning to baseline or near-baseline levels 6 hours after drug administration. The elimination half-life of active doses of MDMA is 8 to 9 hours. The pharmacokinetics of MDMA in humans has been characterized using oral doses of up to 150 mg MDMA. MDMA disposition in the body follows nonlinear pharmacokinetics.
MDMA is a triple monoamine reuptake inhibitor, and similar drugs in this class have been found to exert potent anti-depressant activity with a favorable safety profile in clinical trials. MDMA concomitantly promotes release, inhibits reuptake, and extends duration of serotonin, norepinephrine, and dopamine in the synaptic cleft to increase serotonergic, noradrenergic, and dopaminergic neurotransmission. MDMA has self-limiting subjective and physiological effects due to inhibitory activity on tryptophan hydroxylase, which prevents additional serotonin from being produced and released. This inhibition is reversible.
MDMA produces anxiolytic and prosocial effects through release of the monoaminergic neurotransmitters, with the greatest effect on serotonin, followed by norepinephrine and dopamine. MDMA has been shown to acutely decrease activity in the left amygdala and increase blood flow to the prefrontal cortex (PFC) in the brain. MDMA has also been found to increase serum levels of the neurohormones oxytocin and arginine vasopressin (AVP) in humans. Some studies in healthy volunteers suggest that MDMA increases trust and attenuates reactivity to threatening cues, which are at least partially associated with oxytocin release. The combined neurobiological effects of MDMA can increase compassion for self and others, reduce defenses and fear of emotional injury, and make unpleasant memories less disturbing while enhancing communication and capacity for introspection. These factors taken together can provide the opportunity for a corrective emotional experience in the context of therapy. Many of the therapeutic effects of MDMA-assisted therapy are evident within a short period of treatment, often after the initial session.
Increased feelings of interpersonal closeness, changes in social perception and reduced anxiety may make MDMA a suitable pharmacological adjunct to enhance therapy for anxiety disorders, such as PTSD and social anxiety in autistic adults. MDMA may provide a much needed option in the treatment of PTSD and anxiety associated with other conditions. Published results from MAPS studies showed clinically and statistically significant improvements in PTSD severity. As of May 31, 2018, over 1500 individuals exposed to MDMA in controlled research settings (which includes 227 participants in MAPS-sponsored Phase 1 and Phase 2 studies), there have been no unexpected Serious Adverse Reactions to date and expected Serious Adverse Reactions have been rare and non-life threatening. As of the data cut-off, a single expected Serious Adverse Reaction (increased ventricular extrasystoles), has been reported in MAPS-sponsored clinical trials.
Why MDMA for PTSD?
Many therapies for PTSD involve the induction and extinction of abnormal autonomic responses through revisiting traumatic experiences in therapy with an appropriate level of emotional engagement. To be effective, exposure must be accompanied by a degree of emotional engagement or “fear activation” while avoiding dissociation or overwhelming emotion. This has been referred to as working within the “optimal arousal zone” or “window of tolerance”.
The combined neurobiological effects of MDMA increase compassion, reduce defenses and fear of emotional injury, and enhance communication and introspection. MDMA produces anxiolytic and prosocial effects, which counteract avoidance and hyperarousal in the context of therapy. PTSD increases amygdala activity, causing heightened encoding of fearful memories and decreasing blood flow in the prefrontal cortex. In contrast, MDMA acutely decreases activity in the amygdala, and there is some indication that MDMA may increase activity in the prefrontal cortex. Brain imaging after MDMA indicates less reactivity to angry facial expressions and greater reward in happy faces. This action is compatible with its reported reduction in fear or defensiveness, and is in contrast to the stimulation of the amygdala observed in animal models of conditioned fear, a state similar to PTSD. The reduction in stress- induced activation of the amygdala may be supported and enhanced by interacting with the therapy team during and after the MDMA experience. The subjective effects of MDMA create a productive psychological state that enhances the therapeutic process. MDMA is capable of inducing unique pharmacological effects, including decreased fear and increased wellbeing, sociability, interpersonal trust, acceptance of self and others, and ability to address these issues without extreme disorientation or ego loss due to alert state of consciousness. These factors taken together can provide the opportunity for a corrective emotional experience.
A combined treatment of MDMA and therapy may be especially useful for treating PTSD because MDMA can attenuate the fear response of a perceived threat to one’s emotional integrity and decrease defensiveness without blocking access to memories or preventing a deep and genuine experience of emotion. Elimination of these conditioned fear responses can lead to more open and comfortable communication about past traumatic events and greater access to information about them. Participants are able to experience and express fear, anger, and grief with less likelihood of feeling overwhelmed by these emotions. MDMA seems to engender internal awareness that even painful feelings that arise are an important part of the therapeutic process. In addition, feelings of empathy, love, and deep appreciation often emerge, along with a clearer perspective of the trauma as a past event, a more accurate perspective about its significance, and a heightened awareness of the support and safety that exists in the present. As a result, MDMA-assisted therapy may enable participants to restructure their intra-psychic realities and develop a wider behavioral and emotional repertoire with which to respond to anxiogenic stimuli.
The therapeutic method is described in further detail in the Treatment Manual of MDMA- Assisted Therapy, which sites and therapy teams will be trained on prior to delivery of treatment. https://maps.org/treatmentmanual
How do I learn more about the design and structure of MDMA-assisted therapy for PTSD?
Please read the Treatment Manual for a full description of the MDMA-assisted therapy modality, design and therapeutic approach. (maps.org/treatmentmanual) Sites and therapy providers inquiring to work on an MDMA PTSD protocol should be familiar and comfortable with the Treatment Manual before submitting an application.
A full course of treatment involves three 90-minute Preparatory therapy sessions, three total 8-hour MDMA therapy sessions, and nine total 90-minute Integrative therapy sessions, summing about 42 hours of therapy. There may be additional visits for screening, follow-up, phone contact, and in case of emergency. The MDMA PTSD Expanded Access protocol may allow the option to deliver fewer than three MDMA therapy sessions, as determined by clinical judgment and the needs of the patient. All sessions are administered by a Therapy Pair, two providers for every one participant/patient, utilizing a non- directive approach and an ability to work with extreme states.
What is the status of an MDMA PTSD Expanded Access protocol?
On January 14th, 2019, MAPS Public Benefit Corporation (MAPS PBC) submitted an MDMA- assisted therapy for PTSD protocol to the US Food and Drug Administration (FDA) as part of an application to participate in the FDA Expanded Access (EA) program. The FDA protocol review process is expected to take 30-60 days, pending commentary period. We are hopeful about Expanded Access, though it is important for us to relay that the protocol is pending approval by the FDA, as well as the Drug Enforcement Administration (DEA) and the Independent Review Board (IRB).
The Expanded Access MDMA-Assisted Therapy for Posttraumatic Stress Disorder is currently under FDA review, with protocol approval pending. After obtaining FDA approval, the protocol will be submitted for Drug Enforcement Administration (DEA) and Independent Review Board (IRB) approvals.
What is required to work on an MDMA PTSD Expanded Access protocol, once it is approved?
The basic requirements for a site to be eligible to work with MAPS PBC on an MDMA PTSD Expanded Access protocol (pending approval) include:
1) Treatment Facility conducive to MDMA- assisted therapy,
2) Therapy Team qualified and able to complete required training, made up of at least two therapy providers, and
3) Prescribing Physician who can obtain a Drug Enforcement Administration (DEA) Schedule 1 license for MDMA.
The attached document outlines each of these requirements in more detail.
What are the facility requirements for MDMA-assisted therapy for PTSD?
• Established Business: A qualifying site for Expanded Access consideration is an established business entity, with standard business operations in place: accounting, staffing, administrative support, technology, resources, supplies, operating policies, regular auditing, tax compliance.
• Payments: The site has a system in place for billing patients and paying staff.
• FDA Jurisdiction: Since the FDA Expanded Access Program only applies to the US, sites must be within that jurisdiction.
• Physical Location: An established physical location could be a therapy office, mental health clinic, psychiatry office, medical office, hospital, university, research institute, Veteran’s Administration (VA), county office, or other kind of facility appropriate for conducting the business of the protocol. Consider accessibility for patients (commute time, parking, public transportation) and proximity to nearest hospital.
• Therapy Room: The site has at least one treatment room where 8-hour therapy sessions can take place, with enough space for a couch or futon, where a patient may recline and sit up, and two comfortable chairs (one for each co-therapist) within arm’s reach, without feeling cramped. The room may need to be accessible on weekends depending on scheduling or privacy needs. More than one treatment room may be desired or required depending on site capacity and number of therapy pairs. Photo examples of therapy room set up are included below, from existing MDMA-assisted therapy study sites.
• Comfortable: The therapy room(s) convey a warm, welcoming, and comfortable environment, or could be redesigned or decorated to do so. The room has good natural light, non-fluorescent, and ideally windows with blinds or curtains.
• Privacy: The therapy room is a private space, where conversation cannot be overheard by others in the building and outside noises aren’t likely to distract a patient receiving treatment. MDMA-assisted therapy may sometimes involve loud music or noises, which the room and building should be able to accommodate; consider if sound insulation is necessary.
• Overnight Plan: A plan for overnight stays will be reviewed to ensure that safe and comfortable alternative lodging is available, either on-site at the treatment facility or in a suitable location nearby, when it is not advisable for a patient to return home. It is likely that overnight stays will not be required for all participants, however the option must be available.
• Temperature Control: Therapy room(s) have temperature control options with AC and heat or fans and a space heater or can be outfitted with these.
• AV: The site has the ability to install audio and video recording equipment in the therapy room(s). Cameras and microphones may be stored out of view when not in use.
• Sound System: The site has the ability to install quality speakers and a stereo system to play music simultaneously in the therapy room and through headphones.
• Bathroom: There is a bathroom easily accessible from the therapy room, ideally without requiring contact with other people. Non-fluorescent lighting. Shower is optimal but not necessary.
• Loud Activities: MDMA-assisted therapy sessions incorporate music and non- ordinary states, which can sometimes be loud activities. Consider how your site might handle this given concurrent business practices.
• Zoning: The site meets all local and regional zoning laws for medical visits, storage of controlled substances, and overnight (non-medical) stays. Check on any limitations on hours of operation for the business as stipulated by local zoning and city laws.
• Property Agreements: The conduct of protocol activities is not prohibited by any rental, lease, home owner, or any other agreements on the building. The protocol includes 8- hour therapy sessions with music, overnight (non-medical) stays and storage and administration of a controlled substance.
• Internet: The site has high-speed internet or the ability to install it.
• Office Area: For the Study Coordinator and the administrative needs of the business.
• Medical Records: The site has space to store medical records appropriately.
• Computer: The site has one or more computers to support data entry.
• AED: The site has a functioning defibrillator (AED), or the ability to obtain one.
• BPM: The site has a functioning blood pressure machine, or the ability to obtain one.
• Alarm System: Site already has or can install a functional alarm system, with monitoring of main entrances and drug storage, window break sensors, and 24-hour monitoring service. (hardwire, wifi, or magnetic sensors are all likely acceptable)
• Drug Storage Room: Site has a closet or windowless room with solid doors, a locking handle, and a deadbolt. An alarm with key pad entry can be installed on this closet or windowless room. The drug storage area should only be accessible to authorized site staff. Alternatively, institutions may have an on-site pharmacy authorized to store Schedule 1 substances.
• Steel File Cabinet: Steel file cabinet with a file locking bar and ability to add an additional pad lock. (This would be stored in alarmed closet or windowless room.)
• DEA Site Visit and Approval: After an Expanded Access protocol is approved, each site must apply for a DEA Schedule 1 license, which requires an eligible DEA Schedule 1 License Holder (MD or DO usually) and at least one site visit from a local DEA agent. This process can take several weeks or months once initiated. MAPS PBC can provide assistance to MDMA-PTSD sites acquiring Schedule 1 status after an Expanded Access protocol is approved. Sites administering MDMA-assisted therapy with approval from the DEA are subject to DEA audit.
• Site IRB?: Does this site have any required institutional reviews? MAPS PBC uses a central Institutional Review Board (IRB); sites with their own IRB will also need to meet those requirements.
Examples of therapy room set up:
How do I apply to be considered for training and to work on an Expanded Access protocol, once approved?
For sites and therapy providers interested in working on an Expanded Access protocol, there are two layers of application: 1) Site Questionnaire and 2) MDMA Therapy Training Application for Providers. Each site must submit one Site Questionnaire. Additionally, each therapy provider who wishes to complete training in order to qualify to work on an MDMA-assisted therapy protocol must submit an MDMA Therapy Training Application for Providers. Only applicants affiliated with a qualifying site can be considered for training.
Each application takes approximately 30 minutes to complete. You can save and return to work on your application at your convenience by creating a free Formsite account (instructions on first page of each application). Once you have completed the application, the final page will prompt you to confirm and submit. MAPS PBC will review applications on an ongoing basis, as they are received. Applicants can expect a response 3-6 weeks after submitting a complete application.
Site Questionnaire Link:
MDMA Therapy Training Application for Providers Link:
The Site Questionnaire has several sections, including questions about the business and facility with which you are affiliated, and several open response questions. You will be asked to attach photos of the facility and therapy room(s).
The MDMA Therapy Training Application for Providers has several sections, including questions about you, your professional experience and training, the site with which you are affiliated, and several open response questions. You will be asked to attach a current CV or resume, copies of any licenses you hold, and a headshot photograph. The application includes an option to indicate which training cohort(s) you are interested in applying for. Therapy providers will be enrolled in the training program as space allows, with preference given to qualified applicants who are affiliated with an eligible site and physician. Applicants who are not able to enroll in one of the confirmed training cohorts will be placed on a waitlist for a future cohort and will be notified as soon as space becomes available.
Is there Expanded Access outside of the United States and US Territories?
Only sites in the US and US territories may participate in the US FDA Expanded Access program. Over the coming years, as Phase 2 and 3 trials in Europe progress and additional protocols are developed and approved internationally, the MDMA Therapy Training Program plans to offer more training opportunities internationally. Each country has a unique set of regulations; many regions have programs similar to Expanded Access, sometimes called “Compassionate Use.” International programs may become available in the future.
What’s the best way to stay up to date about MDMA PTSD Expanded Access and the MDMA Therapy Training Program?
Please sign up to receive updates via the MDMA Therapy Training Email Newsletter (https://www.maps.org/participate/therapist- training-program) and visit the Connect Portal (https://connect.mdmatherapytraining.com) for networking and general questions on MDMA PTSD Expanded Access.
What are the requirements for a physician?
• Medical Doctor (MD), Doctor of Osteopathy (DO), or another eligible prescriber who could pass a background check and acquire a DEA Schedule 1 license. This could be an MD practicing internal medicine, psychiatry, or any specialty that authorizes them to prescribe medication. The prescribing physician should already carry a DEA Schedule 2-5 license.
• This DEA Schedule 1 license holder is responsible for the management, administration, and storage of MDMA at the site.
• A physician is required to perform medical screening, including medical history and lab work review, conducting a physical, and advising on medication tapering. In addition, the site physician oversees participant safety throughout the study. This physician may be the DEA Schedule 1 license holder or another approved physician(s).
• The site will need to contract with a Cardiologist to conduct EKG at screening.
• The site will need to contract with a lab to perform blood work at screening.
What are the requirements for a therapy team?
Qualified MDMA Therapy Practitioner Applicants must meet the following pre-requisites:
• Graduated from a degree program with a major in the Mental Health or Medicine fields of study, or the equivalent of three or more years of rigorous study within the field of Mental Health or Medicine
• Holds an active license or registration to conduct therapy or counseling as part of a health profession in the jurisdiction they plan to work, or alternatively, meet all other qualifying criteria and have a plan to pair only with a fully licensed therapy who is trained and qualified to work on a MAPS protocol
• Has conducted at least 1,000 hours of therapy or counseling, or alternatively, has provided 1,000 hours of another therapeutic service such as coaching, spiritual guidance, hospice
• At least 20% of those hours were spent working with adults
• Has worked with trauma populations for at least two years
• Has received at least 30 hours of personal therapy or counseling
• Are working with an eligible site that has submitted a Site Questionnaire
Practitioners who believe they meet the eligibility requirements are encouraged to submit an MDMA Therapy Practitioner Training Application for consideration and to reference and utilize the discussion forums within the Connect Portal [https://connect.mdmatherapytraining.com].
- Therapy Pair: The MDMA-assisted therapy protocol is administered by a Therapy Pair, two providers who work side-by-side to conduct therapy with a study participant/client.
- One License Minimum: At least one of the providers on a Therapy Pair must be fully licensed, and in good standing, to conduct therapy according to state and local requirements.
- Second Provider: The second provider in a Therapy Pair does not necessarily need to be licensed to conduct therapy but must display training in therapeutic relationship, ethics, and trauma.
- Scope of Practice: Every provider is responsible for working within their scope of practice and competence. Each Therapy Pair must have competencies for working therapeutically with people who have PTSD.
- Training Requirement: All providers must complete the MDMA Therapy Training Program (approx. 100 hours plus Supervision) and fulfill any recertification requirements. An outline of the training program can be found below.
- Supervision Requirement: All trainees must complete one Supervision case, of the first patient they treat. Therapy sessions will be video and audio-taped for review by a Supervisor. Therapy Pairs may select a MAPS Supervisor to work with and meet for a minimum number of supervision hours.
- Cost: Each trainee is responsible for their own tuition and supervision fees and any other expenses necessary to complete the MDMA Therapy Training Program. See description of tuition fees below.
- Required Certifications: Each provider must complete any required certifications, including ICH Good Clinical Practice (GCP) and HIPAA, before working under an Expanded Access protocol, and must maintain certification for the duration of their work on the protocol. The details of these programs will be provided upon acceptance into the MDMA Therapy Training Program.
- Background Check: Each training applicant must submit and be able to pass a background check.
- Documentation: Each training applicant must provide supporting documents (including copies of licenses and certificates held) prior to enrollment.
- Multiple Pairs: Each site may have multiple Therapy Pairs.
- Minimum Age: Providers must be 18 years of age or older.
- Recertification: Providers must maintain their certificate of training in good standing by adhering to ethical practice guidelines and recertifying to maintain active status. One pro-bono case may be required as part of a recertification process in an effort to provide access for patients who do not have financial means to access treatment.
What does the MDMA Therapy Training Program include?
MDMA Therapy Training Program Outline:
(subject to change)
- Part A: Online Course, online course outlines chemistry and history of MDMA, common reactions, possible mechanisms of action, and study design. The online course was developed out of content from the Treatment Manual, study protocols, and scientific literature on the subject.
- Part B: Training Retreat (7 days), therapy video review and live dialogue with Senior MDMA-assisted Therapy Researchers, covers topics in the Treatment Manual. Trainees are taught how to conduct study sessions, provide non-directive therapy, and adhere to treatment protocol.
- Part C: Experiential Learning (3+ days), MAPS PBC is developing a protocol that would provide trainees with the opportunity to work alongside a senior MDMA therapist during an MDMA therapy session, in the spirit of apprenticeship. Additionally, the protocol would provide an opportunity for trainees to receive MDMA-assisted therapy, if they choose to volunteer and are eligible. The experiential opportunity in psychedelic therapy training has proven invaluable according to previous trainees.
- Part D: Practice Session (1 day), Therapy Teams from a given site gather to conduct role play didactic training. Role play scenarios are provided, and each trainee gets a chance to play the role of provider, participant, and observer. Total time: 6-8 hours. The role plays will be video and audio recorded so that recording may be reviewed by a Supervisor.
- Part E: Supervision and Evaluation, trainees receive in-depth video review and clinical supervision during the treatment of their first participant receiving MDMA-assisted therapy. Supervision is provided by Senior MDMA-assisted Therapy Researchers. Timely feedback is given to trainees to maximize learning and enhance the quality of treatment. All therapy sessions for that participant must be audio and video recorded so that recordings may be viewed by a Supervision. A final evaluation is provided in the form of a narrative summary from the Supervisor. Trainees who have satisfied all the training requirements will be granted a certificate of completion.
What is the tuition cost of the MDMA Therapy Training Program?
Tuition information for the 2020 training year will be available in the coming months.
What is the process for a therapy provider to be enrolled in the MDMA Therapy Training Program?
- Affiliate with a treatment facility that is qualified to work on a MDMA PTSD protocol
- Submit MDMA Therapy Training Application for Providers
- Await application review response from the MDMA Therapy Training Program
- If accepted, follow provided instructions to complete enrollment and registration
What is the process for my site to participate in MDMA PTSD Expanded Access, if approved ?
1. Confirm that your site meets initial eligibility by reviewing the facility requirements
2. Identify a qualified therapy team that would work at your site (review Therapy Team requirements in attached document)
3. Identify a qualified physician that would work with your site (see requirements attached)
4. Submit a Site Questionnaire
5. Encourage each therapy provider affiliated with your site to complete an MDMA Therapy Training Application for Providers
6. Await review and response from MAPS PBC
7. If your site and therapy team are accepted, each therapy provider will need to successfully complete the MDMA Therapy Training Program. Upon final evaluation of each trainee, the MDMA Therapy Training Program will issue a certificate of completion, authorizing approved teams to continue treating patients in an MDMA PTSD protocol.
8. MAPS PBC will assist approved sites in walking through the start-up process, including: IRB and DEA Schedule 1 regulatory approvals, drug storage guidelines, training on study procedures, data management, set up of recording equipment, etc.
What are the costs associated with working on a MDMA PTSD Expanded Access protocol, if approved?
In addition to the normal operating costs of a therapy clinic, becoming eligible to work on a MDMA PTSD protocol requires special consideration for delivering MDMA-assisted therapy.
MDMA PTSD Expanded Access, pending approval, is a cost-recovery program, meaning that a fee may be charged to recover the cost of drug and the cost of treatment. A template budget model for sites is being developed and will be shared in this forum once it is available. Each site will set the treatment fee that they will charge patients. Sites are encouraged to set reasonable fees, consider sliding scale, and seek ways of reducing patient cost, such as assessing insurance reimbursement for segments of the treatment (in consultation with MAPS PBC), raising funds to sponsor patients, collaborating with MAPS PBC on the development of Patient Assistance Programs, and offering a percentage of pro-bono service.
The following is an incomplete list of expenses to consider in the delivery of MDMA-assisted therapy:
- Overhead such as rent, utilities, alarm/security, internet, cleaning
- Start-up costs such as DEA registration fee (estimated at $250), furnishing and decorating treatment room (if it is not already), blood pressure cuff, AED machine, drug storage installation, alarm installation, video and audio recording equipment (MAPS PBC will provide recommendations on cost-effective AV equipment- please do not purchase in advance unless your site is already equipped)
- IRB costs including initial review (estimated at $1,100) and subsequent annual review (estimated at $1,100)
- Supplies such as urine tests, paper, postage, batteries, snacks and electrolyte beverages
- Staff time spent on screening, treatment, and administration, including therapy team, physician, coordinator, and other administrative staff
- Medical tests such as EKG, physical exam, clinical labs (some of these expenses may be eligible for insurance reimbursement according to the patient’s healthcare plan)
- Drug costs (MAPS PBC is working to set a reasonable fee for sites to purchase MDMA for the purpose of treating patients on an approved protocol- this information will be provided when it is available)
- Overnight stays in the pending Expanded Access protocol are optional as determined by clinical judgment and the needs of the patient. Expenses associated with overnight stays include but are not limited to: additional rent or lodging fees, additional food costs, laundry. Consider whether additional staff time will impact the expense of an overnight stay, such as additional hours of the therapy team and whether a paid or volunteer Night Attendant will be present.
- Therapy training costs for each therapy provider, including tuition for the MDMA Therapy Training Program, supervision fees, travel to and from training events. Please see Tuition topic in this forum for current fee schedule.
- What other expenses might your site incur in offering MDMA-assisted therapy as a modality?
MAPS PBC is dedicated to making MDMA-assisted therapy an accessible treatment. We hope this sample of anticipated costs is informative and supports you in planning. Sites that are concerned that start-up or operational costs will be a barrier to their participation in the protocol are encouraged to post ideas and questions here. MAPS PBC is making initiatives to support sites in start-up, including the development of templates and resources for fundraising, budgeting, scholarship, and patient assistance programs. Information will be posted in the Connect Portal as soon as it is available.