Summer 2002 Vol. 12, No. 2 From Celebration to Frustration, and Back Again
Approximately one year ago, we reported on the progress of our efforts to study psilocybin as a therapeutic agent in patients who suffer from obsessive-compulsive disorder (OCD) and fail to respond to standard anti-obsessional treatment.
At that time we reviewed the rationale for this study as well as the series of steps undertaken in order to make this project a reality. We will take this opportunity to share with you our progress since that time.
After a number of challenges and delays, we have been able to obtain final Investigational New Drug (IND) approval for research with psilocybin from the U.S. Food and Drug Administration (FDA), with MAPS paying for the synthesis of the psilocybin. We also obtained a certificate of confidentiality from the Drug Enforcement Administration (DEA), which is a legal tool that allows us to collect information from potential subjects without an obligation to report to any regulating bodies or criminal authorities, protecting in this manner the confidentiality of study participants. Since then we have been able to obtain additional research support from organizations such as MAPS, who facilitated the training of staff, and the Heffter Research Institute which provided support for the costly inpatient stays required as part of this protocol. We then obtained a special license from the US DEA to prescribe and dispense psilocybin in the context of this research. Once all requirements were completed we obtained the approval of the University of Arizona Human Subjects Committee, to begin recruitment.
Our team has entertained a large number of inquiries, and approximately fifteen interested subjects have engaged in several aspects of screening and consenting. Out of the subjects that engage in formal screening we are hoping that about 20 to 30% will be eligible to participate in testing. Thus far we have completed testing of one subject and remain very optimistic about the study outcome. Testing takes place in a specialized procedure room at the Psychopharmacology Research Section of the University of Arizona Health Sciences Center. We have recently developed a contract with our hospital that will allow us to admit subjects overnight for observation in the psychiatric unit as mandated by the FDA.
Since testing is very time consuming and requires up to four day-long sessions each separated by about one week, we hope to continue testing subjects at a rate of one per month. In order to accomplish this we still need to work hard at recruiting patients who meet study entry criteria. The MAPS website (http://www.maps.org) has been a major source of referral for us, so we encourage the readership to consider promoting study participation for appropriate subjects.
Another challenge for our study has been the fact that a number of interested subjects live in distant parts of the country, making it difficult to travel and/or remain in Arizona for several weeks at a time. We hope that in the future we may be able to assist participants with some financial support to make their participation possible.
Our group remains very positive about this study, and we hope to be able to share with you exciting results when it is opportune.