Updates related to the US MDMA/PTSD Intern Study MPI-1 can be found below:
MPI-1 Intern Study
May 4, 2012
U.S. Intern Study: FDA Gives Official Go-Ahead for New Boulder Study
On May 4, 2012, the U.S. Food and Drug Administration notified the MAPS clinical team that our new “intern study” of MDMA-assisted psychotherapy for subjects with PTSD had been cleared for initiation. The study will take place in Boulder, Colorado with Marcela Ot’alora as Principal Investigator. The FDA cleared the study as it was designed, with no changes required prior to initiation. The new study will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. The use of interns is an effort both to reduce costs and to train the next generation of psychedelic psychotherapists. The study will be initiated once the study physician has received his Schedule I license from the DEA, which we anticipate will take place within the next month.
U.S. Intern Study: DEA Conducts Inspection of MDMA Storage Facility
On May 3, 2012, an official from the Denver office of the Drug Enforcement Administration conducted an inspection of the safe and facility to be used to store the MDMA for our upcoming intern study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The inspection is required to establish that the MDMA storage site is adequately secure and compliant with federal regulations. However, since the safe was at the study physician’s office rather than where the treatments will take place, it will need to be unbolted from the floor and moved to the treatment location. Once the safe has been moved, a new inspection will be required. Once we have met the DEA’s security requirements, the study physician will be granted his Schedule I license and we will proceed with the study initiation and begin screening subjects.
U.S. Intern Study: Therapist Teams Complete Training in South Carolina
From April 8-11, 2012, the therapist teams for our MDMA-assisted psychotherapy for PTSD “intern” study completed therapist training in Charleston, South Carolina, with MDMA-assisted psychotherapy researchers and co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. The new intern study will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. The intern study will take place in Boulder, Colorado, and will be our second clinical trial site in the United States.
U.S. Intern Study: Protocol Passes 30-Day FDA Review Period, Cleared for Initiation
On March 27, the study protocol for our upcoming U.S. intern study of MDMA-assisted psychotherapy for PTSD was cleared for initiation by the FDA after we received no response during the mandated 30-day review period. We contacted the FDA to verify the status of the protocol and learned that they are very busy and we should hear from them in about three weeks. Our research team originally submitted the protocol to the FDA on February 27. This is not a setback, since the study physician is still waiting on his Schedule I license from the DEA.
U.S. Intern Study: IRB Grants Unconditional Approval for Study Protocol
On March 9, the protocol for our planned U.S. intern study of MDMA-assisted psychotherapy for PTSD received approval from the Institutional Review Board, conditional on the pending approval of the study physician’s Schedule I license. The day before, on March 8, the IRB had requested several changes to the subject informed consent documents. MAPS’ clinical team made the changes, resubmitted the documents, and obtained approval in less than 24 hours. The study initiation meeting will be scheduled once the DEA approves the study physician’s license application, which was submitted on March 6. The DEA has no time limit on its response, but we are hopeful that we will be able to begin the study before the summer.
U.S. Intern Study: IRB Grants Conditional Approval, Protocol Submitted to FDA
On March 8, 2012, the protocol for our planned intern study of MDMA-assisted psychotherapy for PTSD received conditional approval from the Institutional Review Board (IRB) pending a few minor modifications to study documents. The protocol was submitted to the FDA on February 27, and is now awaiting review. This study will take place in Boulder, CO, and will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. This approach will help train a new generation of therapists as well as help reduce study costs. The key question is whether outcomes will be similar to when the male/female co-therapist team is composed of two trained therapists.
The protocol was submitted to the IRB on March 1 and reviewed on March 8, the same day conditional approval was granted. This study will take place in Boulder, Colorado, and will be our second U.S. trial site. The study will explore the effectiveness of MDMA-assisted psychotherapy for PTSD using two different doses of MDMA (125 mg followed by a 62.5 mg supplemental dose, and 40 mg followed by a 20 mg supplemental dose). We are evaluating whether a slightly larger low dose (40 mg) than in our previous studies will be a way to create an effective double blind with just two treatment groups. The study will also enable us to make formal comparisons of the effectiveness of the therapy between different therapeutic teams. The Boulder team will participate in our therapist training program in Charleston, SC, from April 8-11, 2012, before beginning the study.
We have already received pledges of $125,000 for this study—about half the total cost—and are seeking the remaining $125,000.
On February 27, 2012, the protocol for our planned intern study of MDMA-assisted psychotherapy for PTSD was submitted to the U.S. Food and Drug Administration for review. This study will take place in Boulder, CO, and will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure.
MDMA-Assisted Psychotherapy Intern Study Protocol Under Development
On December 9, 2011, the MAPS clinical team met with the site team at Cartographie Psychedelica to plan for our planned intern study of MDMA-assisted psychotherapy for PTSD. This study will investigate the effectiveness of MDMA-assisted psychotherapy when one member of the standard male/female co-therapist team is a healthcare intern. The study will be led by Marcela Ot’alora G., M.A., L.P.C., and will take place in Boulder, CO. At the December 9 meeting, the clinical team began planning for a visit to the study site, and made some final adjustments to the study design. The team discussed the logistics of the trial site and Schedule I license application, reviewed investigator responsibilities according to Good Clinical Practice (GCP) guidelines, and determined how investigators could best prepare themselves for conducting the study. The protocol design stage has now been completed, and documents are being prepared for submission to FDA and Institutional Review Board. Discussions are underway for scheduling a five-day therapist training seminar for the Boulder team.
