Investigator-Initiated Trials Application Form - Multidisciplinary Association for Psychedelic Studies

Please complete the information as prompted in this form to submit a research collaboration request to MAPS Public Benefit Corporation (MAPS PBC). At this time, MAPS PBC can only consider investigator-initiated trial (IIT) proposals pertaining to research with the compound MDMA.
Please read the MAPS Privacy Policy before starting your application.
Proposed Research Concept
Overview*
Please provide a brief (1 paragraph) summary of the major design elements of your proposed research study and describe the impact of your study on psychedelic research (Note that more detailed questions about your study design and qualifications are asked below):
Proposed treatment and comparator*
Please describe the treatment being considered for this study. Please also describe any comparator treatment being considered for this study, if applicable:
Population*
Please describe the population(s) being considered for this study:
Geographic location of study:*
Please describe the geographic location being considered for this study:
Recruitment*
Please describe your methods for participant recruitment. Please also describe your site and/or team's prior experience with this population or in this region with regard to conducting outreach, assessing eligibility, enrolling, and retaining in research protocols (If relevant, include any multilingual staff on your team):
Enrollment*
How many participants are you considering for enrollment in this study? (Note: A typical IIT may enroll between 10 and 40 participants, depending on the indication and procedures.)
Screening*
How many participants do you think you will need to 1) phone screen and 2) clinic screen to achieve your stated enrollment target?
Number of MDMA medicine sessions per participant*
Dosing*
Please describe the dosing schema you are considering for this study:
Preparation and Integration Therapeutic Model*
Please describe the preparation and integration therapeutic model you are considering for this study (if applicable):
Primary Objective and Outcome Measure*
Please state the primary objective and outcome measure being considered for this study:
Secondary Outcome Measure*
Please state the secondary objective and outcome measure being considered for this study:
Exploratory Outcome Measure(s)*
Please state any exploratory objective(s) and outcome measure(s) being considered for this study (if known):
Planned sub-studies*
Please state any planned sub-studies, if any:
Research Setting*
Will your study take place at an institution or within a private practice?
- Institution
- Private Practice
Research Setting*
Please specify the name of the institution or private practice:
Impact of concurrent work*
Is there other research planned or ongoing that requires the participation of the same or similar participant population, the same staff, and or the same resources planned for use in this study? What is the relative timing of those activities and how would they impact the proposed work?
Proposed Study Statistical Analysis Plan
CFR Part 11 compliant software*
Please describe which CFR Part 11 compliant data collection software package you are currently using:
Does your site have a designated database programmer/data manager?*
- Yes
- No
Have you budgeted to hire a database programmer/data manager?*
- Yes
- No
Does your protocol team include a statistician?*
- Yes
- No
Statistical Analysis Plan*
Please provide a brief summary of your statistical analysis plan:
Site human subjects research infrastructure and capacity
Overview*
Describe your site’s access to features necessary to conduct investigational drug clinical trials in humans (e.g., therapy treatment rooms – with accessible bathrooms and showers, point-of-care/CLIA-waived laboratory capability, any necessary imaging capability and facilities, overnight facilities, restricted access data storage, restricted access scheduled substance storage, onsite pharmacy, etc.):
To which IRB (Institutional Review Board) or REC (Research Ethics Committee) do you plan to submit the proposed research:*
Describe this IRB/REC's history of reviewing experimental/scheduled drug research protocols:*
Will you need to submit to any additional IRBs or RECs due to protocol team member affiliations? If so, please describe:*
Please describe your team's past experience applying to an IRB or REC for human subjects research approval:*
Other than the IRB/REC, is there another scientific advisory board who will be reviewing the research, such as that for a grantmaking body to whom you have applied for funding? Please describe:*
Have you done or will you do a community consultation to culturally inform your research, such as with a community advisory board (CAB), focus groups, or interviews with key opinion leaders/key informants? Please describe if applicable:*
MAPS PBC has implemented new JEDI initiatives. We would like to provide you the opportunity to describe your investigative team in terms of self-identification with key JEDI groups, e.g., BIPOC, LGBTQIA+, Veteran, disability status, etc. Note: You may answer that you prefer not to say.*
Investigational New Drug (IND) Application*
Please describe your team's prior experience with applying to a regulatory body for investigational drug research (Investigational New Drug (IND) application to the FDA or similar application to a relevant regulatory authority):
Scheduled Substance License*
Please describe your team's prior experience applying for a scheduled substance license (e.g., DEA Schedule I or local equivalent):
Experience with import permit for an investigational substance*
If you are proposing a study outside of the United States, please describe your team's prior experience applying for an import permit for a scheduled or investigational substance. Please also include links to any relevant country-level regulations about the import of experimental and controlled substances, such as guidance on printed label specifications, container type, etc.
Protocol Collaborators*
We recommend having the following personnel on your research team: a) a study coordinator to assist with regulatory submissions, b) a physician to monitor safety (required), c) at least one licensed mental health provider (required for therapy protocols), d) a statistician, e) a database programmer, and f) MAPS-trained therapists. Please identify the following collaborative roles you have already recruited to participate on the research protocol:
- Select All
- Study coordinator
- Safety clinician
- A licensed mental health provider
- A statistician
- A database programmer/data manager
- MAPS-trained therapists
- None of the above
Training and Supervision
Have you, the investigator, completed the MAPS MDMA-Assisted Therapy training?*
- Yes
- No
How many therapists have you identified for your proposed study team?*
How many of your therapists have completed the MAPS MDMA-Assisted Therapy training already?*
Therapists using this study for full certification*
How many of your therapists plan to use this protocol to become fully certified MAPS therapists? Note: This may not apply to all protocols
Any MAPS Therapy Training Supervisors on your team?*
Are you, the investigator, or is anyone on your therapy team a MAPS Therapy Training supervisor?
- Yes
- No
If your collaboration is approved, are you willing to be a host site for other already trained MAPS therapists in your geographic area to gain either supervision/full certification, or gain supervisor certification? Note: For some large institutions, credentialing external providers may present a barrier to this, so this may not apply to all sites.*
- Yes
- No
Timeline and Funding
Please note all IITs accepted for collaboration will be required to submit a budget for feasibility review.
Timeline*
When is your proposed study start date (first subject first visit, FSFV) for your study? Please note the typical life cycle of an investigator-initiated trial from concept to first subject enrolled is at least one year and often longer (due to the time it takes to get all necessary approvals) and may also be dependent upon availability of investigational drug supply, MAPS PBC strategic priority evaluation, and investigator response time.
Funding Overview*
Please note, arrangement for IIT funding is the responsibility of the Sponsor-Investigator. The IIT program has limited funds available (a few projects per year), which may consist of donations in-kind for study drug or training fees. Do you require that your project be considered for this type of financial support?
- Yes, this project requires funding for training
- Yes, this project requires funding for study drug
- No, this project does not require funding
Funding Description*
Please describe any funding you have already identified for this research proposal or your plan for fundraising. If applicable, describe any donations in kind from your institution or affiliated partners:
Funding Review*
If your project is not fully funded and the MAPS PBC IIT program cannot fund your project, are you still interested in submitting this IIT concept note for our review?
- Yes
- No
Sponsor-Investigator Information
Name and Academic Credentials*
Please include the sponsor-investigator's full name and academic credentials:
Experience*
Please describe the sponsor-investigator's relevant clinical trial or research experience, particularly with providing investigational agents to human subjects (e.g., Phase I-IV), FDA IND research, or working with scheduled substances.
Institutional Affiliation*
Please include the sponsor-investigator's institutional affiliation:
Describe, if any, prior relationships or collaborations with MAPS and/or MAPS PBC:*
Email*
Additional Proposed Collaborators*
Please list any additional proposed collaborators you identified above, and their qualifications:
Please note the requirements to be met if MAPS PBC accepts your concept:*
The MAPS PBC IIT program is highly competitive. We receive many more research proposals each year than we are able to accept. We have set requirements for each step of the collaborative process in order to move projects efficiently through the activation process. Please read the requirements listed below and affirm that you understand each:
- Receipt of initial proposal draft by MAPS PBC in 30 days from concept acceptance notification.
- Evidence of a planned budget in 60 days from concept acceptance notification. (For feasibility review only, MAPS PBC does not provide funding)
- Finalization of proposal in 90 days from concept acceptance notification.
- If advanced to protocol stage, finalization of protocol no more than 180 days from proposal acceptance.
Documents: CV*
Please attach the sponsor-investigator's current and signed CV. Submissions without a CV attachment will not be considered.
Drop files here or

Accepted file types: pdf, doc, docx, jpg, png, gif, ppt, pptx, Max. file size: 2 GB, Max. files: 5.
Documents: GCP*
Please attach the sponsor-investigator's certificate of ICH GCP training. Submissions without a GCP attachment will not be considered.
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Accepted file types: pdf, doc, docx, jpg, png, gif, ppt, pptx, Max. file size: 2 GB, Max. files: 5.
Documents: License*
Please attach the sponsor-investigator's current license to practice. Submissions without a license will not be considered.
Drop files here or

Accepted file types: pdf, doc, docx, jpg, png, gif, ppt, pptx, Max. file size: 2 GB, Max. files: 5.
Documents: Proposal (Optional)
Optional: If available, please attach any completed proposal(s) associated with this submission.
Drop files here or

Accepted file types: pdf, doc, docx, jpg, png, gif, ppt, pptx, Max. file size: 2 GB, Max. files: 5.
Please read the MAPS Privacy Policy before submitting your application.
Consent Check: Privacy Policy*
- I consent to the MAPS Privacy Policy.
The data collected in this survey will be sent as an email to our relevant team members who process investigator-initiated trial applications, then the data will automatically be removed from our website's database within seven days of your submission. To receive a copy of your data in an email, or to request the deletion of your data, please send an email to privacy@maps.org
Consent Check: Data Collection*
- I consent to the data collection process and I understand how to interact with my data.

Proposed Research Concept

Proposed Study Statistical Analysis Plan

Site human subjects research infrastructure and capacity

Training and Supervision

Timeline and Funding

Sponsor-Investigator Information