Part of the reason that this study is designed as a pilot study is to examine how patient self-titration actually works in practice. Given that this is a pilot study, it is not necessary to generate data sufficient to determine a dose-effect relationship. Dr. Leshner expresses the concern that the study is confounded because patients will be given a two-week supply of the study drug each time they go to the clinic for evaluation. The Marinol studies provided patients with bulk supplies of Marinol on a take-home basis and the FDA had no trouble evaluating the data that was generated. When patients came in for evaluation, they brought their bottles along with any unused pills and exchanged them for new supplies.
Most clinical trials give patients sufficient medication to last at least several weeks.
Requiring patients to obtain their medicine on a daily basis would impose too great a burden on both the research team and the patients and would serve no overriding useful purpose. Since giving patients a two-week supply of medication is of special concern to NIDA regarding marijuana, it is possible to utilize microelectronic monitoring methods to determine exactly when each daily allotment of marijuana was taken out of a container that permanently records the date and time of each removal. This technology is already commercially available and can be used in this study if NIDA insists. In this way, the research team will be able to monitor drug use patterns in a very precise manner. Federal Register Vol.