DEA Issues License After Over One Year

The DEA has, after over one year, issued a license for Dr. John Halpern’s study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer. The final regulatory approval has thus been obtained. Additional approvals have already been received from two Institutional Review Boards (IRB-McLean and Lahey Hospitals) as well as the Food and Drug Administration (FDA) and the Massachusetts Department of Public Health. MAPS has donated over $94,000 to McLean Hospital over the last five years in an effort to initiate the evaluation of MDMA-assisted psychotherapy. One fruit of this support has been Dr. Halpern’s $1.8 million grant from the National Institute on Drug Abuse (NIDA) for a methodologically state-of-the art study started with MAPS funding of the neurocognitive consequences of the use of Ecstasy. Now that the MDMA/cancer anxiety study is fully approved, MAPS is withdrawing from any further financial sponsorship. MAPS, independent of McLean and Dr. Halpern, still hopes to assist with seeking donors interested in now donating directly to McLean Hospital. We believe that this financial distance from MAPS, and more so the rigor of the methodological design of the study itself, will enable the results of the study to be viewed by skeptics as more objective. If the results of the pilot study are promising, MAPS will again explore options for the support of research at McLean Hospital.