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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
Provide an overview (3-4 paragraphs) of the background literature on the indication proposed for study, including epidemiologic data, current state of treatments, previous research by the current team or broader field, and rationale for the current treatment proposal. Note that MAPS PBC can only accept novel study designs with scientific and medical merit which are not replicas of prior MAPS-sponsored work.
Provide a brief (1 paragraph) summary of the major design elements of your proposed research study including study design style, randomization scheme, blinding, visit schedule, and follow-up information. Additionally, describe the impact of your study on psychedelic research (e.g. novel contribution). It is highly advised that a Schedule of Activities (SoA aka Time and Events) table is attached at the end of this submission – proposals accompanied by detailed SoAs will be evaluated more favorably by the review committee than those without. Note that more detailed questions about your study design and qualifications are asked below:
Describe the treatment being considered for this study. Also describe any comparator treatment being considered for this study, if applicable. Describe the safety of the comparator and how it was chosen over other possible comparators. If the comparator is a standard of care, this should be mentioned in the background and rationale section.
Describe the population(s) being considered for this study (age, sex or gender, in/outpatient, occupational group, etc.).
Describe the geographic location being considered for this study.
Describe methods for participant recruitment. Also describe the site and/or team’s prior experience with this population or in this region with regard to conducting participant outreach, eligibility assessment, enrollment, and retention in research protocols (If relevant, include any multilingual staff on the study team).
How many participants are being considered for enrollment?
How many participants will need to be 1) phone screened and 2) clinic screened to achieve the stated enrollment target?
Specify the number of MDMA medicine sessions per participant.
Describe the dosing schema being considered for this study. Note that cGMP MDMA HCl provided by MAPS PBC for IITs comes in the standard formulations of 40 mg and 60 mg capsules. MAPS PBC does not provide API at this time.
- Click here for sample inclusion and exclusion criteria
Refer to the sample IC/EC above for key cardiac, kidney/liver, psychiatric, and reproductive standards based on the psychopharmacologic profile of MDMA. Also consider any additional IC/EC which may be unique to your study population/indication.
Describe the validated and/or manualized preparation and integration therapeutic model being considered for this study. Be specific and do not simply reference “the MAPS model” as replica studies will not be considered for IIT collaboration.
- Click here for FDA's Compendium of Clinical Outcome Assessments by disease area
State the (single) primary objective and outcome measure as well as timepoint being considered for this study. Refer to the FDA’s Compendium of Clinical Outcome Assessments (COAs) by disease area, linked above.
State the (single) secondary objective and outcome measure as well as timepoint being considered for this study.
State the safety objectives and outcome measures considered for this study. May refer to publicly available prior MDMA-AT protocols for safety objectives and outcomes measures standard to MDMA-AT clinical trials.
State any exploratory objective(s) and outcome measure(s) as well as timepoints being considered for this study (if known).
State any planned sub-studies, if any:
Identify the specific risks of administering MDMA or studying MDMA-AT in your specific target population or intervention structure (e.g. elevated cardiac risk, vulnerable population, breach of confidentiality risk of treatment setting/format). Describe the risk/benefit profile of conducting your intervention, and steps taken in each case to minimize risk and why this is acceptable.
Will your study take place at an institution or within a private practice?
Please specify the name of the institution or private practice where the study will take place:
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
Describe the CFR Part 11 compliant data collection software package that will be used.
Provide a detailed summary of your statistical analysis plan, as previously discussed with and reviewed by your statistician. This includes sample size calculations, the test statistic(s) to be calculated, hypotheses to be tested, and any hierarchical or multiple testing correction plans. Note lack of a robust a priori stats plan will lead to a less favorable evaluation of your proposed project by our review committee.
Site human subjects research infrastructure and capacity
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.).
Describe the 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). Note that due to the highly rigorous nature of conducting scheduled drug trials in humans as well as the competitive nature of the program, project teams comprised of investigators with IND filing experience will be most favorably evaluated.
Describe the team’s prior experience applying for a scheduled substance license (e.g., DEA Schedule I or local equivalent).
If proposing a study outside of the United States, describe the team’s prior experience applying for an import permit for a scheduled or investigational substance. 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.
We recommend having the following personnel on the 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 or identified to participate in the research protocol:
Therapy Training
Timeline and Funding
Please note all IITs accepted for collaboration will be required to submit a budget for feasibility review.
When is the proposed study start date (first subject first visit, FSFV) for this study? 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 be dependent on the availability of investigational drug supply, MAPS PBC strategic priority evaluation, and investigator response time.
MAPS PBC is not currently able to provide funding for IITs. As such, it is the expectation by MAPS PBC that sponsor-investigators will arrange for their own funding for their trial(s). Describe any funding you have identified for this research proposal or your plan for fundraising. If applicable, describe any donations in kind from your institution or affiliated partners:
Sponsor-Investigator Information
Provide the Sponsor-Investigator's full name and academic credentials.
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.
Provide the Sponsor-Investigator's institutional affiliation.
List any additional proposed collaborators not already depicted.
Please attach the sponsor-investigator's current and signed CV. Submissions without a CV attachment will not be considered.
Please attach the sponsor-investigator's certificate of ICH GCP training. Submissions without a GCP attachment will not be considered.
Please attach the sponsor-investigator's current license to practice. Submissions without a license will not be considered.
Optional: If available, please attach any completed protocol(s) associated with this submission.
If available, please attach a detailed visit-by-visit time and events table including all procedures and visit windows.
Please read the MAPS Privacy Policy before submitting your application.
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