Open Label Stage Sample Clauses

Open Label Stage. 2 (Low Dose Subjects from Stage 1) a. Subjects will be reminded that participation in Stage 2 is voluntary and optional. b. Subjects who elect to cross over to Stage 2 will undergo the same course of therapy and evaluation as in Stage 1, but with full dose MDMA during three experimental sessions. c. Assessment of PTSD symptoms at the primary endpoint will serve as baseline assessments in Stage 2. d. If the start of Stage 2 is delayed for more than 30 days from the primary endpoint (Visit 12) to the first preparatory session in Stage 2 (Visit 18), the IR will re- administer the CAPS, PDS, BDI-II, GAF and PSQI, and these scores will be used as the baseline for comparison to assessment at the secondary endpoint and the end of Stage 2. e. Subjects entering Stage 2 will meet with both therapists for a single preparatory psychotherapy session. f. Subjects will have the same sequence of experimental sessions and integrative therapy as full dose subjects in Stage 1 in an open-label context (e.g. without unblinding). Visits will be scheduled consecutively according to the Time and Events Table. g. The same outcome measures completed by full dose subjects in Stage 1 will be administered during Stage 2. h. The same safety measures as those in Stage 1 will be administered during Stage 2. i. The End of Stage 2 will be completed in the same manner as the End of Stage 1. (See section 5.2.8) j. Investigators will follow the most recent treatment manual in all matters relating to the Open-Label Stage 2 experimental psychotherapy sessions
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