To launch the trial, Barnes first had to apply for a license with the DEA for permission to work on a Schedule 1 drug, a process that includes at least one visit from DEA agents. The agents ensure that the compound is kept in a secure facility that only certain personnel can enter and has electronic security measures—something Barnes did not initially have. He also needed to fill out a new form for each stage of his study, and for any changes to the study design.
Hussain says he knew setting up his clinical trial would be difficult, but it proved even more challenging than he had expected. Apart from getting the DEA’s permission, he had to have his protocol approved by the California State Department of Justice and the FDA. He also needed to navigate university politics, convincing staff there that the study would be legal, and wouldn’t damage