Psychedelia.dk

MDMA er alle tiders pausestof, men jeg ved ikke hvordan det vil virke sammen med al den medicin, du tager. Og hvis du er deprimeret, risikerer du at få det endnu værre bagefter. Men start med at tage en lille dosis (40-50 mg.), og se hvordan det går.

I thought I had solved the now-classic problem of the placebo in psychedelic research in my dissertation, by proposing to use low doses of the drug being tested and compare them to full doses. The low doses, I reasoned, could cause sufficient blinding by generating some confusion among subjects and therapists about whether a low dose or a full dose had been administered, while not providing a full therapeutic effect which would make it difficult to compare outcomes and show a difference between the two groups.

MAPS’ series of Phase 2 studies demonstrated that the lower doses did indeed result in a substantial increase in the percentage of incorrect guesses by subjects, therapists and CAPS raters, so the blinding was sufficient. However, to our surprise, we also found that low doses—while they were sufficient to produce a more effective blind—tended to make subjects anxious and uncomfortable, feeling emotionally activated but still not quite able to suppress their fear responses to their trauma. Lower doses of MDMA actually had the effect of reducing the benefits of therapy compared to an inactive placebo, thereby making it easier to show a statistically significant difference between our full dose and the control condition. Therefore, we proposed to the FDA that our Phase 3 design involve administering the same psychotherapy to both groups while administering full doses of MDMA to one group and inactive placebos to the control group. Now that FDA has provided MAPS with an Agreement Letter, we know that our final results will not be challenged on the basis of an unsuccessful double-blind.