On January 16, Health Canada first responded to our Canadian MDMA/PTSD protocol design. They accepted almost all elements of the protocol but had some items they wanted changed. We also asked for a change in the kind of previous treatments for PTSD the subjects will be required to have tried and failed.
On January 20, we submitted our replies, accepting some changes and making our best argument for why it was important to include people who were free from substance abuse histories for the last 6 months rather than for the last 12 months, as Health Canada had suggested. In addition, we asked to be able to include subjects who failed on other psychotherapy and either tried and failed, or refused medication. Health Canada had suggested including only subjects who had failed on other psychotherapy, and had tried and failed to obtain relief from medication – excluding subjects who refused to try medication.
On February 3, we heard from Health Canada that our responses had been accepted and that our protocol design had been fully approved (Hooray!). This shows yet again that it is possible to negotiate with regulatory agencies that put science first.
On January 12, we heard from Health Canada’s chemistry reviewers. We’ve been gathering our replies ever since, which included obtaining a new analysis of the heavy metals and residue on ignition of the MDMA. In addition, Health Canada had a series of questions about the capsules, the lactose filler, and the bottles in which the capsules will be stored.
On February 2, Professor Rudolph Brenneisen from Switzerland provided MAPS with documents regarding the chemical make-up of the MDMA that will be imported to Canada from Switzerland. Ironically, the last bit of information we need to gather is the batch number of the lactose!
We expect to submit the required chemistry information in the next few days. Once the protocol is approved, we can start the process of obtaining the import/export permits for the MDMA from Switzerland, and can then start the study itself.