There’s a real need for large clinical trials. There have been a few on psilocybin and LSD as preventatives. The big obstacles are recruiting a sufficient number of patients and obtaining funding to study substances that aren’t directly patentable. Demonstrating the efficacy of DMT as an abortive compared to placebo could be done on very few patients and reach high statistical significance. Demonstrating greater efficacy than Sumatriptan—a standard abortive—would be more difficult, as the latter is also fast-acting and effective in the short term. Sumatriptan is widely believed among patients to cause rebound attacks and to lose effectiveness over time, so a proper comparative study would probably need to follow patients over a period of months. I don’t think that DMT would have to be legal (e.g. for personal use) to be studied as a controlled substance—just authorisation would be needed.
To what extent are the legal restrictions on psychedelics also obstacles to running trials with them in major pharmaceutical R&D countries like the US?
There was a small trial that was recently completed at Yale. The administrative hurdles are greater, including DEA approval in the US, but certainly not insurmountable. It might be easier in some other countries with more permissive laws and where psychedelics have already been legally prescribed, like Canada and Switzerland, but approval is still necessary.
There’s a real need for large clinical trials. There have been a few on psilocybin and LSD as preventatives. The big obstacles are recruiting a sufficient number of patients and obtaining funding to study substances that aren’t directly patentable. Demonstrating the efficacy of DMT as an abortive compared to placebo could be done on very few patients and reach high statistical significance. Demonstrating greater efficacy than Sumatriptan—a standard abortive—would be more difficult, as the latter is also fast-acting and effective in the short term. Sumatriptan is widely believed among patients to cause rebound attacks and to lose effectiveness over time, so a proper comparative study would probably need to follow patients over a period of months. I don’t think that DMT would have to be legal (e.g. for personal use) to be studied as a controlled substance—just authorisation would be needed.
To what extent are the legal restrictions on psychedelics also obstacles to running trials with them in major pharmaceutical R&D countries like the US?
There was a small trial that was recently completed at Yale. The administrative hurdles are greater, including DEA approval in the US, but certainly not insurmountable. It might be easier in some other countries with more permissive laws and where psychedelics have already been legally prescribed, like Canada and Switzerland, but approval is still necessary.