The drug product is (3,4)-methylenedioxymethamphetamine HCl. As described in the Introductory Statement, MDMA is also referred to as N,-alpha-Dimethyl-1,3- benzodioxole-5-ethanamine, and is described by the chemical formula C11H15NO2. The drug is a white, crystalline powder. The drug will be administered orally in capsules. Complete details on the chemistry, manufacturing and control of the MDMA HCl to be used are described in Drug Master file # 6293. As described in that file, MDMA was prepared for human consumption by David Nichols, Ph.D., Dept. of Medicinal Chemistry and Pharmacology, Purdue University. The identity and purity of this MDMA was reconfirmed using HPLC in 1997 as described in DMF # 6293 and was found to be 99.87% pure. On August 12, 2002, Chemic Laboratories reanalyzed the MDMA at the request of the sponsor in relation to the study of MDMA-assisted psychotherapy in people with posttraumatic stress disorder, the analysis found it to be more than 99.7% pure. There was no evidence of deterioration at that time, 17 years following original synthesis in 1985.
MDMA is a Schedule I drug and will be handled in accordance with all federal, state, hospital, and university regulations.
Records pertaining to the use of Schedule I compounds will be maintained in accordance with relevant Federal and State Regulations. These records will be kept separate from other records and will be maintained in the Pharmacy at the McLean Hospital in an appropriately secured file cabinet. These records will include:
The control forms, each with a unique identifying number, will be obtained from and tracked by the Pharmacy at McLean Hospital.
As described in "Drugs and Dosage" above, MDMA will be weighed out (calculated as the weight of the hydrochloride salt) into gelatin capsules in combination with lactose used to ensure that all capsules have similar weights. The lowest dose contained in one capsule will be 12.5 mg, which is the supplemental dose offered to participants in the low dose condition, and the highest dose contained in one capsule will be 125 mg, which is the initial dose offered to participants in the Experimental Intervention condition on the second experimental session. Capsules will be prepared in such a way as to prevent investigators and participants from distinguishing contents of a Low Dose capsule from capsules containing Experimental Intervention doses.
Lactose will be used as the inactive compound used in admixture with MDMA to ensure that all doses will be of the same weight.
MAPS claims categorical exclusion from the requirement to submit an environmental assessment (21 CFR 25.15[a]). MAPS claims categorical exclusion (under 21 CFR 25.31[e]) for the study under this IND. To its knowledge, no extraordinary circumstances exist.