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NEW FDA-APPROVED PSILOCYBIN RESEARCH NEEDS DONATIONS

The first FDA-approved study in over 25 years to examine the use of psilocybin in a patient population is now underway. The principal investigator, Dr. Francisco Moreno, University of Arizona, Tucson, plans to study the use of psilocybin in 10 patients suffering from obsessive-compulsive disorder (OCD). They want to determine if they can replicate in a clinical study several published case reports of patients whose OCD symptoms were reduced after self-experimentation with psilocybin mushrooms.

Study Protocol          Informed Consent Form

February 10, 2004 Eight subjects have been treated so far, and no complications have occurred.

August 20, 2003: Seven subjects have been treated so far, and and eighth has been enrolled. No complications have occurred so far.

August 6, 2002: The second patient in this study was treated.

November 27, 2001: The first patient was treated in the psilocybin/OCD study. The treatment session went well without complication. The study is completely up and running!

October 24, 2001: MAPS organized and funded a series of talks and a Grand Rounds lecture by Dr. Stan Grof to the University of Arizona, Tucson psilocybin/OCD experimental team. Dr. Grof spoke about how to conduct psychedelic psychotherapy research and helped the team prepare for their treatment sessions.

July 2, 2001: We have just received word from Dr. Francisco Moreno that the final approvals from DEA for the psilocybin/OCD study have come through. The DEA certificate of confidentiality (protecting the privacy of the volunteers) was received by the research team; the physicians' DEA Schedule 1 licenses (to handle the psilocybin) were received the week before. The study is now totally approved by all the necessary regulatory agencies. Subject recruitment will now begin.

May 8, 2001: On May 8, we received word from the FDA that they approved for human use the psilocybin MAPS had made at a DEA-licensed lab. The study won't start for about 2 more months since the researchers need to get their DEA licenses to handle psilocybin.

December 28, 2000: MAPS agreed to pay an additional $1850 for an FDA-requested HPLC (high-performance liquid chromatography) analysis of the psilocybin that MAPS had produced for the experiment. This analysis will be completed before the middle of January.

Sepetember 28, 2000: The synthesis of the psilocybin is now completed, with the details of the synthesis to be submitted soon to FDA. FDA review expected to take between 4-8 weeks.

September 14, 2000: Synthesis of the psilocybin is expected to be completed in early October. After the synthesis is completed, the FDA must then review the data about the synthesis and then approve the material for human use, a process that is estimated to take between one and two months.

May 2000: MAPS just sent a check for $10,527 to the University of Arizona Department of Psychiatry, to pay for the psilocybin for the OCD study. Producing the psilocybin will probably take 2-3 months, then the study can start.

January 2000: A manufacturer for the psilocybin has been found. Negotiations are in progress between the university lawyers and the manufacturer because the manufacturer needs a guarantee that it will not be sued in case someone has a bad experience in the study.

MAPS is assisting the researchers to raise $10,527 for their study, the cost of the psilocybin. If you would like to make a tax-deductible contribution to this historic study or would like more information, please contact MAPS at the address below. Progress in the field of psychedelic research is only possible with the support of individuals who care enough to take individual and collective action...

References
Delgado PL, Moreno FA, (Oct-Dec 1998) Hallucinogens, Serotonin and Obsessive-Compulsive Disorder, J of Psychoactive Drugs. 30(4) pp 359-366.

Delgado PL, Moreno FA (1998) Different roles for serotonin in anti-obsessional drug action and the pathophysiology of obsessive-compulsive disorder. Br J Psychiatry Suppl. (35):21-5.

Moreno FA, Delgado PL, (Jul 1997) Hallucinogen-induced relief of obsessions and compulsions. Am J Psychiatry 154(7):1037-8.

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2105 Robinson Avenue
Sarasota, FL 34232
USA
E-mail: info@maps.org
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Tel: 941-924-6277
Fax: 941-924-6265