Rationale of Dose Selection Sample Clauses

Rationale of Dose Selection. This study will compare the effects of psychotherapy sessions assisted by full or low dose MDMA. Low dose will be 40 mg MDMA followed 1.5-2.5 hours later by 20 mg, and the full dose will be 125 mg followed 1.5-2.5 hours later by 62.5 mg. Table 1. Dose Regimen Initial Dose Supplemental Dose Cumulative Dose Low Dose 40 mg 20 mg 60 mg Full Dose 125 mg 62.5 mg 187.5 mg The full MDMA dose to be used in this study is identical to those used in previous studies in the U.S., Switzerland and Israel. Previous researchers have also used doses within this range [62, 63, 65, 67, 79, 96-100]. Prior to the scheduling of MDMA, similar doses and regimens were used in psychotherapy [49, 51, 54]. The initial full dose is expected to produce all the commonly reported effects of MDMA. The supplemental dose will prolong subjective drug effects without producing physiological effects any greater than peak effects occurring after the initial dose. The low dose of MDMA was chosen on the basis of its demonstrated ability to produce detectable subjective effects as a part of the sponsor’s ongoing initiative to optimize the double blind in MDMA-assisted psychotherapy using dose response. It is very similar to doses used in Phase 1 studies [63, 68]. This dose is expected to produce increases in positive mood and tension, in combination with a lower degree of therapeutic effects than the full dose.
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Related to Rationale of Dose Selection

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